GeneCure Biotechnologies reported clinical data of the first-in-human novel therapeutic HIV vaccine trial

Therapeutic HIV vaccine showed promising safety and efficacy


Peachtree Corners GA, May 13, 2015 (GLOBE NEWSWIRE) -- GeneCure Biotechnologies, a clinical stage biotechnology company developing novel human vaccines based on its patented lentiviral delivery platform technology, announced today that its Chief Executive Officer, Dr. Frank Tung presented a talk entitled A Randomized, Double blinded, Placebo Controlled Trial of a Therapeutic HIV Vaccine at the 18th annual meeting of the American Society of Gene and Cell Therapy in New Orleans, Louisiana, USA.

Although current antiretroviral therapies (ART) are effective in controlling viral load in HIV infected patients, the virus typically re-emerges soon after secession of ART. Dr. Tung’s presentation focused on GeneCure’s ongoing therapeutic HIV vaccine (HIVAX) clinical trial investigating its potential of controlling viral load in HIV-infected patients. HIVAX was tested for safety and immunogenicity in 15 HIV-infected patients undergoing ART. Patients were randomized 2 to 1 to receive HIVAX or placebo (as control). The primary endpoints were safety and immunogenicity. HIVAX was well tolerated without severe adverse effects and was highly immunogenic in all HIVAX vaccinated HIV patients. Robust CD8+ T cell responses, which play a critical role for recognition and killing of HIV infected cells, were stimulated in all HIVAX vaccinated patients. Following the vaccination, ten patients who received HIVAX suspended ART for 12 weeks in order to assess their ability to control virus re-emergence. Median viral load at the end of the 12-week ART interruption was significantly lower (6.7 folds and 25 folds) than two control cohorts (unvaccinated) described in previously published studies. Furthermore, three HIVAX vaccinated patients extended ART interruption for up to 2 years and still maintain stable CD4+ T cell counts and low viral loads.

HIVAX shows great potential as a therapeutic HIV vaccine to reduce the dependency and adverse effects associated with ART. Based on this promising data, GeneCure is currently recruiting more HIV patients for subsequent clinical trials.

About GeneCure Biotechnologies

GeneCure Biotechnologies is a private biotechnology company developing novel human vaccines based on its patented lentiviral delivery platform. The mission of the company is to develop safe, potent and simple to use human vaccines to manage chronic viral infections and cancers. GeneCure’s lead product is a therapeutic HIV vaccine that is currently being tested as a first-in-human, proof-of-concept therapy for HIV infected patients. Other products in the pipeline include therapeutic Hepatitis C and B vaccines for chronic infected patients. GeneCure also possesses in-house GMP manufacture capabilities for the production of clinical grade materials.

Forward-Looking Statements

This news release contains forward-looking statements, which are based on company’s current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in the statements due to a variety of factors, over which GeneCure Biotechnologies has no control. These forward-looking statements speak only as of the date hereof. GeneCure Biotechnologies disclaims any obligation to update these forward-looking statements.


            

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