National Alliance for Hispanic Health Selected by NIH to Lead Hispanic Engagement in Historic All of Us Research Program

Ambitious effort to enroll 1 million people to accelerate research and improve health

WASHINGTON, July 25, 2017 /PRNewswire-USNewswire/ -- "The future of medicine will be treatment and prevention tailored to the individual. But that future will only be realized if more people in this country are a part of our national science base. Today, our nation took a major step forward with the announcement of four organizations, including the National Alliance for Hispanic Health, to support engagement of diverse communities in the All of Us Research Program," said Jane L. Delgado, PhD, MS, President and CEO of the National Alliance for Hispanic Health, the nation's leading Hispanic health advocacy group.

All of Us is an ambitious effort to gather data over time from 1 million or more people living in the United States, with the ultimate goal of accelerating research and improving health. Unlike research studies that are focused on a specific disease or population, All of Us will serve as a national research resource to inform thousands of studies, covering a wide variety of health conditions. Researchers will use data from the program to learn more about how individual differences in lifestyle, environment and biological makeup can influence health and disease. By taking part, people will be able to learn more about their own health and contribute to an effort that will advance the health of generations to come. 

"Community partners are integral to All of Us," said Eric Dishman, director of All of Us at the National Institutes of Health (NIH). "This first-of-its-kind program seeks to include people from all walks of life, and our community partner awardees were selected to help achieve that goal." 

"We're committed to ensuring that participant perspectives are considered throughout every aspect of the program," said Dara Richardson-Heron, M.D., All of Us chief engagement officer. "Guaranteeing a voice to those who are typically underrepresented in medical research is step one."

"The best health outcomes for all can be achieved, but we all must be a part of the answer. All of Us is a historic opportunity to be a part of the solution and create a healthier future for ourselves and all our loved ones.  You can learn more by visiting https://allofus.nih.gov," concluded Dr. Delgado.

About the National Alliance for Hispanic Health (The Alliance)
The Alliance is the foremost science-based source of information and trusted advocate for the best health outcomes for all. The nation's largest network of Hispanic health and human service providers, our community-based members reach more than 15 million persons throughout the U.S. and our national members provide services to more than 100 million people annually. For more information, visit www.healthyamericas.org or call the Alliance's Su Familia Helpline at 1-866-783-2645.

 

View original content:http://www.prnewswire.com/news-releases/national-alliance-for-hispanic-health-selected-by-nih-to-lead-hispanic-engagement-in-historic-all-of-us-research-program-300494084.html

SOURCE National Alliance for Hispanic Health

National Alliance for Hispanic Health Selected by NIH to Lead Hispanic Engagement in Historic All of Us Research Program

Ambitious effort to enroll 1 million people to accelerate research and improve health

WASHINGTON, July 25, 2017 /PRNewswire-USNewswire/ -- "The future of medicine will be treatment and prevention tailored to the individual. But that future will only be realized if more people in this country are a part of our national science base. Today, our nation took a major step forward with the announcement of four organizations, including the National Alliance for Hispanic Health, to support engagement of diverse communities in the All of Us Research Program," said Jane L. Delgado, PhD, MS, President and CEO of the National Alliance for Hispanic Health, the nation's leading Hispanic health advocacy group.

All of Us is an ambitious effort to gather data over time from 1 million or more people living in the United States, with the ultimate goal of accelerating research and improving health. Unlike research studies that are focused on a specific disease or population, All of Us will serve as a national research resource to inform thousands of studies, covering a wide variety of health conditions. Researchers will use data from the program to learn more about how individual differences in lifestyle, environment and biological makeup can influence health and disease. By taking part, people will be able to learn more about their own health and contribute to an effort that will advance the health of generations to come. 

"Community partners are integral to All of Us," said Eric Dishman, director of All of Us at the National Institutes of Health (NIH). "This first-of-its-kind program seeks to include people from all walks of life, and our community partner awardees were selected to help achieve that goal." 

"We're committed to ensuring that participant perspectives are considered throughout every aspect of the program," said Dara Richardson-Heron, M.D., All of Us chief engagement officer. "Guaranteeing a voice to those who are typically underrepresented in medical research is step one."

"The best health outcomes for all can be achieved, but we all must be a part of the answer. All of Us is a historic opportunity to be a part of the solution and create a healthier future for ourselves and all our loved ones.  You can learn more by visiting https://allofus.nih.gov," concluded Dr. Delgado.

About the National Alliance for Hispanic Health (The Alliance)
The Alliance is the foremost science-based source of information and trusted advocate for the best health outcomes for all. The nation's largest network of Hispanic health and human service providers, our community-based members reach more than 15 million persons throughout the U.S. and our national members provide services to more than 100 million people annually. For more information, visit www.healthyamericas.org or call the Alliance's Su Familia Helpline at 1-866-783-2645.

 

View original content:http://www.prnewswire.com/news-releases/national-alliance-for-hispanic-health-selected-by-nih-to-lead-hispanic-engagement-in-historic-all-of-us-research-program-300494084.html

SOURCE National Alliance for Hispanic Health

Creative Medical Technology Holdings Demonstrates AmnioStem Derived Exosomes Inhibit Glioma Growth

Company's Unique Stem Cell Nanotechnology Approach Appears to Stimulate Regeneration of Healthy Brain Cells While Selectively Inhibiting Glioma Brain Cancer

SAN DIEGO and PHOENIX, July 25, 2017 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. (OTCQB:CELZ), a clinical stage stem cell company, announced preclinical data showing exosomes harvested from its patented AmnioStem amniotic fluid stem cell, selectively inhibit growth of glioma brain cancer cells. 

Exosomes are nanoparticles generated by a variety of cells that are critically involved in intercellular communication.  The Company previously filed patents on the use of AmnioStem derived exosomes for treatment of stroke1.  The AmnioStem technology was originally licensed from the University of California San Diego (UCSD), under an exclusive agreement covering issued US Patent #7,569,3852.

"Having seen first-hand the devastation and lack of treatment options in glioma patients, I am excited about the prospect of developing a non-toxic biological approach that eventually may provide benefit to this group of patients," said Santosh Kesari, MD, Ph.D, FANA, FAAN, Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, as well as Director of Neuro-oncology, Providence Saint John's Health Center and leads the Pacific Neuroscience Research Center at Pacific Neuroscience Institute.

"The filed patent application contains data showing that while AmnioStem derived exosomes inhibited proliferation of glioma cells, other stem cell types actually increased proliferation of glioma," said Thomas Ichim, Ph.D, Chief Scientific Officer of Creative Medical Technology Holdings.  "We are currently working under the possibility that AmnioStem stem cells may possess unique biological properties that are different from other types of stem cells."

"From a commercialization perspective, exosomes are simpler to manufacture, store, and deliver as compared to living cells.  Additionally, since exosomes are not replicating cells, we anticipate a less complicated FDA regulatory pathway as compared to cellular based products," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings.

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to www.creativemedicaltechnology.com.

Forward-Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at www.sec.gov.

1 http://www.prnewswire.com/news-releases/creative-medical-technology-holdings-files-patent-on-amniostem-stroke-therapy-300376848.html
2 http://www.prnewswire.com/news-releases/creative-medical-technologies-receives-exclusive-license-to-key-amniotic-fluid-stem-cell-patent-from-university-of-california-system-300356233.html

 

View original content:http://www.prnewswire.com/news-releases/creative-medical-technology-holdings-demonstrates-amniostem-derived-exosomes-inhibit-glioma-growth-300493868.html

SOURCE Creative Medical Technology Holdings, Inc.

Tongue Lab Launches its First Clinical Trial in Prague to Study the TRP’s (Tongue Right Positioner) Impact on Chronic Snoring

PARIS and PRAGUE, July 25, 2017 /PRNewswire/ --

The TRP aims to train and recondition the tongue, returning it to its physiological functions and position, and increasing muscle tone. Using the TRP could reduce, even eliminate, snoring.

Tongue Lab, maker of the TRP (Tongue Right Positioner), launched in Prague its first clinical trial to evaluate the benefits of the TRP on snoring. The TRP is a medical device that enables the tongue to return to its physiological functions and positions, thus increasing muscle tone. The study will be carried out by Dr. Filip Bochnicek, a dentist in Prague, and supervised by Dr. Petr Janda, Director of Prague Clinical Services.

     (Logo: http://mma.prnewswire.com/media/538859/Tongue_Lab_Logo.jpg )

Thirty-five men and women who have been diagnosed as chronic snorers will be enrolled in the study, which will be conducted over nine months. Every three months, their snoring levels will be measured to evaluate the consequences of wearing the TRP while sleeping.

Snoring is related to dysfunctions of the tongue that deplete lingual muscle tone, loosen pharyngeal tissue and reduces the width of the pharynx. During sleep, these weakened muscles are drawn backward in the oral cavity. This backward movement reduces the diameter of the already narrowed pharynx and hinders the passage of air. Snoring is the sound that results with each incoming breath.

Jean-Michel Mauclaire, Founder and President of Paris-based Tongue Lab, warns that snoring is not a trivial matter. It is often linked with high blood pressure and can indicate the presence of obstructive sleep apnea (OSA), which results from the tongue obstructing the pharynx. OSA is a serious condition with significant repercussions, including cardiovascular disease, diabetes, depression, diminished sexual desire and chronic fatigue. OSA often goes undiagnosed. In addition to signaling potentially life-threatening illnesses, snoring, particularly when it reaches 70 decibels or more, has an impact on relationships, particularly for couples and families, and the quality of sleep. A bad night's sleep can affect performance at work, school, behind the wheel and at other moments during the day.

The TRP is a connected, custom-fitted oral device designed to treat the lingual dysfunctions that cause sleep breathing disorders. Unlike other devices that address such disorders, it places no artificial pressure on the teeth, upper airways or pharynx. Used nightly for at least six months, the TRP is worn only over the upper teeth. Patients wearing the TRP are able to speak, consume liquids and swallow normally. Ease of use, comfort and discretion are key to optimizing patient compliance and obtaining lasting results. Discover the TRP here.

Mr. Mauclaire is enthusiastic: "The TRP was invented by Dr. Claude Mauclaire, a pioneering orthodontist who's been studying the impact of training the tongue for more than 40 years. Her initial goal was to avoid a relapse of the orthodontic conditions she'd successfully treated. Using the TRP, her patients experienced other benefits as well. The clinical study we're launching today could enable Tongue Lab and its partners to offer an effective and lasting solution to the hundreds of millions of people around the world who snore. That's exciting!"

About Tongue Lab 

Tongue Lab, created in 2012 with operational headquarters in Paris, France, develops and sells the TRP (Tongue Right Positioner), a connected and patented oral medical device designed to train the tongue. Nightly use of the TRP results in neuromuscular conditioning that enables the tongue to assume and maintain its physiological functions and positions. With the TRP, Tongue Lab offers a solution that permanently corrects lingual dysfunctions, which in turn could possibly prevent or heal sleep breathing disorders. Designed for comfort and easy to use, the TRP is available for children and adults through healthcare professionals. Tongue Lab is committed to helping people of all ages improve their health and the quality of their everyday life. For more information, please visit www.tonguelab.net. You can also follow us on Facebook, Twitter and LinkedIn.

Viriom Obtains First Market Approval of Elsulfavirine (Elpida®) for Treatment of HIV-1 Infection in Russia

- Viriom's 20mg Daily Elsulfavirine (Elpida®)-based Regimen Demonstrated High Efficacy in High and Low HIV Titer Patients with Significantly Improved Safety Compared with 600mg Efavirenz-based Regimens -

SAN DIEGO, July 25, 2017 /PRNewswire/ -- Viriom, Inc (Viriom), a San Diego-based biotech company, today announced that on June 30, 2017 the Russian Ministry of Health (MoH) granted an approval to Viriom's non-nucleoside reverse transcriptase inhibitor (NNRTI) elsulfavirine (brand name Elpida®). Non-nucleoside reverse transcriptase inhibitors block HIV replication. The labeling requested was for the "treatment of HIV-1 infection in combination with other antiretroviral medicines." Viriom's first product on the market, elsulfavirine is a new-generation, potentially the best in class prodrug NNRTI approved for the treatment of the HIV-1 virus due to its potency, pharmacokinetic properties and favorable resistance profile.

The Russian MoH based its approval of elsulfavirine on the results of a 48-week multicenter comparative clinical study conducted in 12 clinical centers.  The results presented to the MoH confirmed an efficacy non-inferior to efavirenz (currently used as a first-line treatment of HIV-1); elsulfavirine demonstrated equally superior efficacy in patients with a high or low HIV titer at baseline.  Overall, it was 2-4 times safer and better tolerated than efavirenz including a lower frequency of adverse events related to the CNS, with no allergic reactions or skin rash observed. Elsulfavirine demonstrated a higher genetic barrier to the development of resistant drug mutations. Elsulfavirine is available as a 20mg capsule to be taken orally. Viriom is continuing the development of fixed dose combinations of elsulfavirine for the treatment of the HIV-1 infection and working towards market registration of elsulfavirine and fixed dose combinations globally. Viriom is also developing long-acting, injectable formulations of parent drug VM1500A for treatment and prevention of the HIV-1 infection based on the unique pharmacokinetic and pharmacodynamic properties of elsulfavirine demonstrated in clinical trials to date.

About Viriom:
Viriom focuses on the treatment, prophylaxis, and eradication of infectious diseases globally. Viriom is developing and commercializing the most innovative and affordable solutions to radically expand global access to antiviral treatments. Viriom's broad, proprietary, and partnered pipeline covers therapeutic, prophylactic, and curative medicines for HIV and viral hepatitis. Learn more at www.viriom.com.

Media Contact:
Ronald Demuth, CFO, Viriom
+1(858)-794-4860x321
rdemuth@viriom.com

Safe Harbor Statement

This document may contain forward-looking statements. Such forward-looking statements are characterized by future or conditional verbs such as "may," "will," "expect," "intend," "anticipate," "believe," "estimate" and "continue" or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Such statements are only predictions and our actual results may differ materially from those anticipated in these forward-looking statements. We believe that it is important to publicly communicate future expectations. However, there may be events in the future that we are not able to accurately predict or control. Factors that may cause such differences include, but are not limited to, the uncertainties associated with product development, the market for our products, the risks associated with dependence upon key personnel and the need for additional financing. We do not assume any obligation to update forward-looking statements as circumstances change. The information in this document is not targeted at the residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local law or regulation. The future expectations, estimations, anticipated events, results, milestones, events, operating and financial information contained in the company's financial projections and all other areas of this document are for illustrative purposes only and are based upon hypothetical assumptions and events over which the company has only partial or no control. All information about future events (projections) were developed by the company's management and are based upon a variety of assumptions with or without benefit of an operating history. The projections are included solely to provide information concerning the company's estimates of future operating results based on these assumptions and, although the company believes that these assumptions are reasonable, they may be incomplete or incorrect, and unanticipated events and circumstances may occur. Actual results will vary from the projections, and these variations may be material and adverse. The projections should be read in conjunction with the assumptions upon which the projections are based. No representation or warranty of any kind is or can be made with respect to the accuracy or completeness of, and no representation or warranty should be inferred from our projections or the assumptions underlying them.

 

 

View original content with multimedia:http://www.prnewswire.com/news-releases/viriom-obtains-first-market-approval-of-elsulfavirine-elpida-for-treatment-of-hiv-1-infection-in-russia-300493634.html

SOURCE Viriom, Inc

ViiV Healthcare Announces Superior Efficacy of Dolutegravir Versus Lopinavir/Ritonavir in Second-line HIV Treatment in Resource-limited Settings

LONDON, July 25, 2017 /PRNewswire/ --

DAWNING study modified to allow patients the opportunity to receive dolutegravir-based regimens 

ViiV Healthcare, the global specialist HIV company, majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive interim results from DAWNING. This is a non-inferiority study conducted to compare second-line treatment of the protease inhibitor-sparing regimen of dolutegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs), with a current WHO-recommended regimen of lopinavir/ritonavir and 2 NRTIs in HIV-1-infected adults. Results are being presented at the International AIDS Society congress in Paris.

(Logo: http://photos.prnewswire.com/prnh/20160223/336449LOGO )

The study's Independent Data Monitoring Committee (IDMC) noted significant and clinically-relevant differences between treatment arms in favour of dolutegravir and recommended that the boosted lopinavir treatment arm be discontinued. Participants receiving lopinavir/ritonavir were offered the opportunity to switch to a regimen with dolutegravir as the core agent, if considered appropriate by the investigator.

The primary endpoint was the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at week 48. The 24-week interim data showed an 82% response rate in the dolutegravir arm versus 69% for lopinavir/ritonavir (p<0.001). Key secondary endpoints include evaluation of the development of viral resistance and measurements of safety and tolerability. No subjects in the dolutegravir arm of the study failed treatment with either integrase or nucleoside resistance. The safety data for dolutegravir at week 24 was consistent with previous dolutegravir studies. Additional data from DAWNING will be presented at future medical meetings.

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented "The initial results from DAWNING are important because they not only provide information that may help guide second-line treatment decisions in resource-limited settings, but also reaffirm the position of dolutegravir at the core of HIV care. We are working with investigators to ensure that dolutegravir can be provided to patients in the control arm and are looking forward to sharing the 48-week results, as soon as they will be available."

Notes to editors   

Tivicay is a registered trademark of the ViiV Healthcare group of companies. For more information on the trials please visit: http://www.clinicaltrials.gov

About the DAWNING study   

DAWNING is a phase IIIb, non-inferiority study conducted to compare a protease inhibitor-sparing regimen of DTG and 2 NRTIs with a current WHO-recommended regimen of LPV/RTV + 2 NRTIs in HIV-1 infected patients failing first-line therapy of a NNRTI + 2 NRTIs (ClinicalTrials.gov: NCT02227238). The IDMC performed periodic reviews of data to protect the ethical and safety interests of patients.

Adult patients failing first-line therapy, with HIV-1 RNA ≥400 copies(c)/mL, were randomised (1:1, stratified by baseline plasma HIV-1 RNA and number of fully active background NRTIs) to 52 weeks of open-label treatment with DTG or LPV/RTV combined with an investigator-selected dual NRTI background, including at least one fully active NRTI.

TIVICAY (dolutegravir) tablets   

Professional Indication(s) and Important Safety Information   

Indications and Usage   

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 30 kg

Limitations of use:  

  • Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R

Important Safety Information   

Contraindications:   

TIVICAY is contraindicated in patients:

  • With previous hypersensitivity reaction to dolutegravir
  • Receiving dofetilide (antiarrhythmic)

Hypersensitivity Reactions:   

  • Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in <1% of subjects receiving TIVICAY in phase III clinical trials
  • Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy if hypersensitivity reaction is suspected

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection:   

  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
  • Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C

Fat Redistribution or accumulation has been observed in patients receiving antiretroviral therapy.

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions: The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment-naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).

Drug Interactions:   

  • Coadministration of TIVICAY with certain inducers of UGT1A and/or CYP3A may reduce plasma concentrations of dolutegravir and require dose adjustments of TIVICAY
  • Administer TIVICAY 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TIVICAY and supplements containing calcium or iron can be taken with food
  • Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments

Pregnancy: TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Nursing Mothers: Breastfeeding is not recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

About ViiV Healthcare  

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com.

About GSK   

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.

SOURCE ViiV Healthcare

ViiV Healthcare Announces Superior Efficacy of Dolutegravir Versus Lopinavir/Ritonavir in Second-line HIV Treatment in Resource-limited Settings

LONDON, July 25, 2017 /PRNewswire/ --

DAWNING study modified to allow patients the opportunity to receive dolutegravir-based regimens 

ViiV Healthcare, the global specialist HIV company, majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive interim results from DAWNING. This is a non-inferiority study conducted to compare second-line treatment of the protease inhibitor-sparing regimen of dolutegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs), with a current WHO-recommended regimen of lopinavir/ritonavir and 2 NRTIs in HIV-1-infected adults. Results are being presented at the International AIDS Society congress in Paris.


     (Logo: http://photos.prnewswire.com/prnh/20160223/336449LOGO )

The study's Independent Data Monitoring Committee (IDMC) noted significant and clinically-relevant differences between treatment arms in favour of dolutegravir and recommended that the boosted lopinavir treatment arm be discontinued. Participants receiving lopinavir/ritonavir were offered the opportunity to switch to a regimen with dolutegravir as the core agent, if considered appropriate by the investigator.

The primary endpoint was the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at week 48. The 24-week interim data showed an 82% response rate in the dolutegravir arm versus 69% for lopinavir/ritonavir (p<0.001). Key secondary endpoints include evaluation of the development of viral resistance and measurements of safety and tolerability. No subjects in the dolutegravir arm of the study failed treatment with either integrase or nucleoside resistance. The safety data for dolutegravir at week 24 was consistent with previous dolutegravir studies. Additional data from DAWNING will be presented at future medical meetings.

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented "The initial results from DAWNING are important because they not only provide information that may help guide second-line treatment decisions in resource-limited settings, but also reaffirm the position of dolutegravir at the core of HIV care. We are working with investigators to ensure that dolutegravir can be provided to patients in the control arm and are looking forward to sharing the 48-week results, as soon as they will be available."

Notes to editors   

Tivicay is a registered trademark of the ViiV Healthcare group of companies. For more information on the trials please visit: http://www.clinicaltrials.gov

About the DAWNING study   

DAWNING is a phase IIIb, non-inferiority study conducted to compare a protease inhibitor-sparing regimen of DTG and 2 NRTIs with a current WHO-recommended regimen of LPV/RTV + 2 NRTIs in HIV-1 infected patients failing first-line therapy of a NNRTI + 2 NRTIs (ClinicalTrials.gov: NCT02227238). The IDMC performed periodic reviews of data to protect the ethical and safety interests of patients.

Adult patients failing first-line therapy, with HIV-1 RNA ≥400 copies(c)/mL, were randomised (1:1, stratified by baseline plasma HIV-1 RNA and number of fully active background NRTIs) to 52 weeks of open-label treatment with DTG or LPV/RTV combined with an investigator-selected dual NRTI background, including at least one fully active NRTI.

TIVICAY (dolutegravir) tablets   

Professional Indication(s) and Important Safety Information   

Indications and Usage   

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 30 kg

Limitations of use:  

  • Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R

Important Safety Information   

Contraindications:   

TIVICAY is contraindicated in patients:

  • With previous hypersensitivity reaction to dolutegravir
  • Receiving dofetilide (antiarrhythmic)

Hypersensitivity Reactions:   

  • Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in <1% of subjects receiving TIVICAY in phase III clinical trials
  • Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy if hypersensitivity reaction is suspected

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection:   

  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
  • Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C

Fat Redistribution or accumulation has been observed in patients receiving antiretroviral therapy.

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions: The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment-naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).

Drug Interactions:   

  • Coadministration of TIVICAY with certain inducers of UGT1A and/or CYP3A may reduce plasma concentrations of dolutegravir and require dose adjustments of TIVICAY
  • Administer TIVICAY 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TIVICAY and supplements containing calcium or iron can be taken with food
  • Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments

Pregnancy: TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Nursing Mothers: Breastfeeding is not recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

About ViiV Healthcare  

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com .

About GSK   

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.


ViiV Healthcare Announces Superior Efficacy of Dolutegravir Versus Lopinavir/Ritonavir in Second-line HIV Treatment in Resource-limited Settings

LONDON, July 25, 2017 /PRNewswire/ --

DAWNING study modified to allow patients the opportunity to receive dolutegravir-based regimens 

ViiV Healthcare, the global specialist HIV company, majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive interim results from DAWNING. This is a non-inferiority study conducted to compare second-line treatment of the protease inhibitor-sparing regimen of dolutegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs), with a current WHO-recommended regimen of lopinavir/ritonavir and 2 NRTIs in HIV-1-infected adults. Results are being presented at the International AIDS Society congress in Paris.


     (Logo: http://photos.prnewswire.com/prnh/20160223/336449LOGO )

The study's Independent Data Monitoring Committee (IDMC) noted significant and clinically-relevant differences between treatment arms in favour of dolutegravir and recommended that the boosted lopinavir treatment arm be discontinued. Participants receiving lopinavir/ritonavir were offered the opportunity to switch to a regimen with dolutegravir as the core agent, if considered appropriate by the investigator.

The primary endpoint was the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at week 48. The 24-week interim data showed an 82% response rate in the dolutegravir arm versus 69% for lopinavir/ritonavir (p<0.001). Key secondary endpoints include evaluation of the development of viral resistance and measurements of safety and tolerability. No subjects in the dolutegravir arm of the study failed treatment with either integrase or nucleoside resistance. The safety data for dolutegravir at week 24 was consistent with previous dolutegravir studies. Additional data from DAWNING will be presented at future medical meetings.

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented "The initial results from DAWNING are important because they not only provide information that may help guide second-line treatment decisions in resource-limited settings, but also reaffirm the position of dolutegravir at the core of HIV care. We are working with investigators to ensure that dolutegravir can be provided to patients in the control arm and are looking forward to sharing the 48-week results, as soon as they will be available."

Notes to editors   

Tivicay is a registered trademark of the ViiV Healthcare group of companies. For more information on the trials please visit: http://www.clinicaltrials.gov

About the DAWNING study   

DAWNING is a phase IIIb, non-inferiority study conducted to compare a protease inhibitor-sparing regimen of DTG and 2 NRTIs with a current WHO-recommended regimen of LPV/RTV + 2 NRTIs in HIV-1 infected patients failing first-line therapy of a NNRTI + 2 NRTIs (ClinicalTrials.gov: NCT02227238). The IDMC performed periodic reviews of data to protect the ethical and safety interests of patients.

Adult patients failing first-line therapy, with HIV-1 RNA ≥400 copies(c)/mL, were randomised (1:1, stratified by baseline plasma HIV-1 RNA and number of fully active background NRTIs) to 52 weeks of open-label treatment with DTG or LPV/RTV combined with an investigator-selected dual NRTI background, including at least one fully active NRTI.

TIVICAY (dolutegravir) tablets   

Professional Indication(s) and Important Safety Information   

Indications and Usage   

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 30 kg

Limitations of use:  

  • Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R

Important Safety Information   

Contraindications:   

TIVICAY is contraindicated in patients:

  • With previous hypersensitivity reaction to dolutegravir
  • Receiving dofetilide (antiarrhythmic)

Hypersensitivity Reactions:   

  • Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in <1% of subjects receiving TIVICAY in phase III clinical trials
  • Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy if hypersensitivity reaction is suspected

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection:   

  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
  • Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C

Fat Redistribution or accumulation has been observed in patients receiving antiretroviral therapy.

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions: The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment-naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).

Drug Interactions:   

  • Coadministration of TIVICAY with certain inducers of UGT1A and/or CYP3A may reduce plasma concentrations of dolutegravir and require dose adjustments of TIVICAY
  • Administer TIVICAY 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TIVICAY and supplements containing calcium or iron can be taken with food
  • Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments

Pregnancy: TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Nursing Mothers: Breastfeeding is not recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

About ViiV Healthcare  

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com .

About GSK   

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.


ViiV Healthcare Announces Superior Efficacy of Dolutegravir Versus Lopinavir/Ritonavir in Second-line HIV Treatment in Resource-limited Settings

LONDON, July 25, 2017 /PRNewswire/ --

DAWNING study modified to allow patients the opportunity to receive dolutegravir-based regimens 

ViiV Healthcare, the global specialist HIV company, majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive interim results from DAWNING. This is a non-inferiority study conducted to compare second-line treatment of the protease inhibitor-sparing regimen of dolutegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs), with a current WHO-recommended regimen of lopinavir/ritonavir and 2 NRTIs in HIV-1-infected adults. Results are being presented at the International AIDS Society congress in Paris.


     (Logo: http://photos.prnewswire.com/prnh/20160223/336449LOGO )

The study's Independent Data Monitoring Committee (IDMC) noted significant and clinically-relevant differences between treatment arms in favour of dolutegravir and recommended that the boosted lopinavir treatment arm be discontinued. Participants receiving lopinavir/ritonavir were offered the opportunity to switch to a regimen with dolutegravir as the core agent, if considered appropriate by the investigator.

The primary endpoint was the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at week 48. The 24-week interim data showed an 82% response rate in the dolutegravir arm versus 69% for lopinavir/ritonavir (p<0.001). Key secondary endpoints include evaluation of the development of viral resistance and measurements of safety and tolerability. No subjects in the dolutegravir arm of the study failed treatment with either integrase or nucleoside resistance. The safety data for dolutegravir at week 24 was consistent with previous dolutegravir studies. Additional data from DAWNING will be presented at future medical meetings.

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented "The initial results from DAWNING are important because they not only provide information that may help guide second-line treatment decisions in resource-limited settings, but also reaffirm the position of dolutegravir at the core of HIV care. We are working with investigators to ensure that dolutegravir can be provided to patients in the control arm and are looking forward to sharing the 48-week results, as soon as they will be available."

Notes to editors   

Tivicay is a registered trademark of the ViiV Healthcare group of companies. For more information on the trials please visit: http://www.clinicaltrials.gov

About the DAWNING study   

DAWNING is a phase IIIb, non-inferiority study conducted to compare a protease inhibitor-sparing regimen of DTG and 2 NRTIs with a current WHO-recommended regimen of LPV/RTV + 2 NRTIs in HIV-1 infected patients failing first-line therapy of a NNRTI + 2 NRTIs (ClinicalTrials.gov: NCT02227238). The IDMC performed periodic reviews of data to protect the ethical and safety interests of patients.

Adult patients failing first-line therapy, with HIV-1 RNA ≥400 copies(c)/mL, were randomised (1:1, stratified by baseline plasma HIV-1 RNA and number of fully active background NRTIs) to 52 weeks of open-label treatment with DTG or LPV/RTV combined with an investigator-selected dual NRTI background, including at least one fully active NRTI.

TIVICAY (dolutegravir) tablets   

Professional Indication(s) and Important Safety Information   

Indications and Usage   

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 30 kg

Limitations of use:  

  • Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R

Important Safety Information   

Contraindications:   

TIVICAY is contraindicated in patients:

  • With previous hypersensitivity reaction to dolutegravir
  • Receiving dofetilide (antiarrhythmic)

Hypersensitivity Reactions:   

  • Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in <1% of subjects receiving TIVICAY in phase III clinical trials
  • Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy if hypersensitivity reaction is suspected

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection:   

  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
  • Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C

Fat Redistribution or accumulation has been observed in patients receiving antiretroviral therapy.

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions: The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment-naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).

Drug Interactions:   

  • Coadministration of TIVICAY with certain inducers of UGT1A and/or CYP3A may reduce plasma concentrations of dolutegravir and require dose adjustments of TIVICAY
  • Administer TIVICAY 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TIVICAY and supplements containing calcium or iron can be taken with food
  • Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments

Pregnancy: TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Nursing Mothers: Breastfeeding is not recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

About ViiV Healthcare  

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com .

About GSK   

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.


HedgePath Pharmaceuticals Receives Clarity From FDA Regarding Pathway to Potential Regulatory Submission

HPPI to proceed with streamlined 505(b)(2) regulatory pathway for SUBA(TM)-Itraconazole as a treatment for Basal Cell Carcinoma Nevus SyndromeFDA provides written guidance on data from HPPI's ongoing clinicial trial and the data requirements for NDA filing and potential FDA approval

TAMPA, Fla., July 25, 2017 /PRNewswire/ -- HedgePath Pharmaceuticals, Inc. (OTCQX: HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced that the U.S. Food and Drug Administration (FDA) has provided further guidance regarding HPPI's ongoing, open-label Phase 2(b) clinical trial studying the effect of SUBA-Itraconazole (SUBA-Cap) oral capsules in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome. 

The FDA's guidance came in the form of a written response by FDA to HPPI's Type-C meeting background package.  Such a meeting is a standard element of the regulatory review process leading to a potential New Drug Application (NDA) to FDA.

Nicholas Virca, President and CEO of HPPI, stated that, "We are pleased with the FDA's guidance, since we believe it adds clarity to our regulatory and clinical road going forward for the BCCNS indication of SUBA-Cap.  FDA confirmed that we may follow the more streamlined 505(b)(2) regulatory pathway, which will allow us to reference safety data from previous third-party itraconazole trials, to be supplemented by our own safety database.  The acceptability of this combined safety database will then be determined by the FDA during the course of its review of the future NDA.  FDA also agreed that no additional nonclinical toxicology studies appear necessary to support filing an NDA for SUBA-Itraconazole under the 505(b)(2) pathway."

Importantly, FDA also indicated that it "[w]ould accept a single study to support an NDA if results show a significant effect on a clinically meaningful endpoint.  The results of the single trial must be sufficiently robust and so compelling that it would be unethical to repeat the study . . . [e]vidence of an objective reduction in tumor burden that is durable is important in order to demonstrate antitumor effects of SUBA-Itraconazole in patients with BCCNS and these data should be collected and independently reviewed."

Mr Virca further stated that, "In light of FDA's additional guidance on what might constitute a clinically significant response, we are now undertaking further detailed analyses of individual tumor responses from our ongoing trial seeking to verify the robustness of our therapy in reducing the tumour burden in BCCNS patients.  We intend to present the results of this additional analysis to FDA and continue discussions with them about the utility of such results in a potential NDA submission."

Readers are cautioned that no assurances can be given that (i) the final study results will match the results previously reported on May 30, 2017 or (ii) the study, when and if completed, will achieve its primary and secondary endpoints or (iii) that the study results will be found by FDA to be sufficient for the filing of a NDA, or that one or more additional studies will not be required or (iv) if an NDA is filed, that it will be approved by FDA.  Further, HPPI is not committing to providing further interim updates prior to the reporting of the final study results.

About BCCNS

BCCNS results from a genetic mutation which causes the Hedgehog pathway (a major regulator of processes in cells) to function improperly, leading to the chronic formation of basal cell tumors, including potentially disfiguring lesions on the face. Industry sources estimate that there are approximately 10,000 patients in the United States with BCCNS, which has qualified SUBA-Itraconazole under the FDA's Orphan Drug Designation Program.

About SUBA-Itraconazole

SUBA-Itraconazole is a patented and proprietary itraconazole formulation that enhances the absorption of itraconazole to improve the bioavailability of orally administered drugs that are poorly soluble.  The U.S. rights to SUBA-Itraconazole for the treatment of cancer are exclusively licensed to HPPI by an affiliate of Mayne Pharma Group Limited.  SUBA-Itraconazole was developed to improve absorption and significantly reduce variability compared to generic itraconazole. These benefits provide enhancements to patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical response and a reduction in the active drug quantity to deliver the required therapeutic blood levels.

About HedgePath Pharmaceuticals

HedgePath Pharmaceuticals, Inc. (OTCQX:HPPI) is a clinical stage biopharmaceutical company that is seeking to repurpose the FDA approved antifungal pharmaceutical itraconazole as a potential treatment for cancer.  HPPI is the exclusive U.S. licensee of a patented formulation of itraconazole, called SUBA-Itraconazole, which clinical studies have shown to have greater bioavailability than generic itraconazole.

The Hedgehog signaling pathway is a major regulator of cellular processes in vertebrates, including cell differentiation, tissue polarity and cell proliferation.  Based on published research, HPPI believes that inhibiting the Hedgehog pathway could delay or possibly prevent the development of certain cancers in humans.  Leveraging research undertaken by key investigators in the field, HPPI plans to explore the effectiveness of SUBA-Itraconazole as an anti-cancer agent and to pursue its potential commercialization.  HPPI is headquartered in Tampa, Florida.  For more information, please visit www.hedgepathpharma.com.

Cautionary Note Regarding Forward Looking Statements

This press release and any statements of representatives and partners of HedgePath Pharmaceuticals, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve significant risks and uncertainties.  Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions.  These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission.  Actual results (including, without limitation, the actual timing for, or actual results of, the Company's clinical trial described herein or the FDA's review of any related New Drug Application by the Company) may differ significantly from those set forth or implied in the forward-looking statements (and may further differ from the interim study results described herein).  These forward-looking statements involve numerous risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control).  The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. 

For more information:

Nicholas J. Virca, President and CEO
nvirca@hedgepathpharma.com

Investor Relations Contact:
Garrison Hasara, CFO and Treasurer
ghasara@hedgepathpharma.com

© 2017 HedgePath Pharmaceuticals, Inc.  All rights reserved.

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SOURCE HedgePath Pharmaceuticals, Inc.