GeoVax to Collaborate with Georgia State University On Development of Therapeutic Hepatitis B Vaccine

Targeting Chronic Hepatitis B Infections Affecting More Than 240 Million People Worldwide

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that it has entered into a research collaboration agreement with Georgia State University Research Foundation (GSU) to advance the Company’s development of a therapeutic vaccine for treatment of chronic Hepatitis B Virus (HBV) infections.

The project will include the design, construction, characterization and animal testing of multiple vaccine candidates using GeoVax’s MVA-VLP vaccine platform. Vaccine antigens include both GeoVax and GSU’s proprietary designed sequences. The vaccine design, construction, and characterization will be performed at GeoVax with further characterization and immunogenicity studies in mice conducted at GSU in collaboration with the Shenzhen Graduate School of Peking University. Unique functional assays developed by Dr. Ming Luo, Professor in the Department of Chemistry at Georgia State University, and performed at Peking University will provide key information on vaccine efficacy.

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2016 Top Stories in Gastroenterology: Tenofovir Reduces Risk of HBV Transmission to Infants

Babies born to mothers with chronic hepatitis B virus (HBV) and high HBV DNA levels remain at risk for HBV transmission and development of chronic infection despite routine immunoprophylaxis at the time of birth. Treatment of pregnant women with an oral antiviral agent (lamivudine, telbivudine, or tenofovir) during the third trimester was recommended to reduce maternal HBV DNA levels, although high-quality studies were lacking to establish the efficacy of this approach to reduce mother-to-child transmission. During the past year, Pan and colleagues published results from a randomized controlled trial providing compelling evidence that treatment of mothers with HBV DNA levels >200,000 IU/mL with tenofovir during the third trimester reduces the risk of mother-to-child HBV transmission.1

In this study, 200 HBeAg-positive mothers with HBV DNA levels >200,000 IU/mL were randomized to tenofovir 300 mg daily from 30 to 32 weeks’ gestation until week 4 postpartum, or to a control group whom received no antiviral therapy. All babies received hepatitis B immune globulin and vaccination at time of birth. Mothers did not breastfeed on tenofovir. HBV transmission was assessed at week 28 postpartum.

Main findings

  • In intention-to-treat analysis, in which patients who were lost to follow-up or discontinued treatment were considered as treatment failures, the HBV transmission rate was 5% (5/97) in the tenofovir group compared with 18% (18/100) in controls.

 

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Hepatitis B More Prevalent in Type 2 Diabetes Patients

HealthDay News — Patients with type 2 diabetes have higher prevalence of chronic hepatitis B virus infection (CHB), according to a study published online in the Journal of Diabetes Investigation.

Jun Lu, PhD, from the Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, and colleagues investigated the prevalence of CHB status in different diabetes subtypes among a Chinese population. Participants included 381 cases with adult-onset autoimmune diabetes, 1365 patients with type 2 diabetes, and 1365 controls without diabetes.

The researchers found that patients with type 2 diabetes had higher prevalence of CHB than the controls in the overall population (13.5 vs 10.0%; P = 0.004) and among patients with normal hepatic function (13.3 vs 8.8%; P = 0.002). However, CHB status was not different between patients with adult-onset autoimmune diabetes and the controls. The odds ratio of CHB increased about 1.5-fold in patients with type 2 diabetes, compared to the control group, even after adjustment for age, gender, and body mass index, regardless of hepatic function.

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European Commission Grants Marketing Authorization for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection

Vemlidy® is the First New Treatment for Chronic Hepatitis B Infection to be Approved in the European Union in Nearly a Decade —

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Vemlidy® (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg).

The marketing authorization allows for the marketing of TAF in the 28 countries of the European Union, Norway and Iceland.

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