Genocea Reports Fourth Quarter and Year-End 2015 Financial Results

However, neither result was statistically significant. On October 7, 2015, Genocea reported positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. On the ratings front, Genocea has been the subject of a number of recent research reports. The Company operates through business of developing and commercializing vaccines segment. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p < 0.0001), the primary endpoint of the study and a measure of anti-viral activity. Several key areas of focus will be planning and management, execution monitoring and budget in alignment with department goals, inventory management and logistics. At the company’s heart is a group of scientists with broad international experience in drug discovery and development, and know-how gained at both large and small pharmaceutical companies. AIC246 (Letermovir) was initially tested in healthy volunteers to study drug-drug interactions with Midazolam, Tacrolimus and Cyclosporine showing moderate increases in the co-administered drug concentrations. It is aimed at preventing colonization of the upper airway by all serotypes of pneumococcus. In the USA, it affects about 1.2 million individuals and in Europe about 0.8 million. The phase 1 and phase 2 clinical development of AIC499 is being supported by the Innovative Medicines Initiative (IMI) within the COMBACTE-MAGNET project. But the data show that the experimental vax did not meet its primary endpoint, which was the number of patients having CMV viremia through one year after the first injection of the study drug. Genocea intends to explore additional dose combinations in its upcoming Phase 2 dose optimization study, which may identify a dose which further improves the magnitude or durability of effect of GEN-003. This means ATLAS identifies – not just predicts - antigens to which patients are responding, and can distinguish between those that stimulate productive T cell responses (CD4+ and CD8+ T cells) and those that are irrelevant or may actually inhibit response.
Conventional plaque reduction assays can be very subjective and therefore not reproducible between laboratories. In January 2015, Genocea announced that it completed enrollment early in its Phase 2 dose optimization clinical trial for GEN-003, its first-in-class treatment for genital herpes. In this article, we review vaccine approaches for genital herpes that currently show pre-clinical and clinical promise. A major step for the company was achieved by signing a licence agreement with Merck & Co. GDP rose by 2.9% during the third quarter on an annualized basis, more than double the second quarter growth rate of 1.4% and the highest rate in two years. is another significant milestone for AiCuris” said Prof. TheBody.com fills you in on the topic, when you have genital herpes how often will i break out, with a wealth of fact sheets, expert advice, community perspective, the latest news/research, and much more.

granting Astellas an exclusive, worldwide, royalty-bearing license to develop and commercialize ASP0113 for the control and prevention of cytomegalovirus infection in immunocompromised patients, including transplant recipients, and transplant donors. Nevertheless, pritelivir potently decreases shedding at appropriate doses based on its mode of action and long half-life. Unfortunately, there have been few new pharmacological answers for preventing herpes and many similar diseases that can take root outside of the bloodstream and evade traditional vaccines. Viral shedding is what causes the spread of genital herpes. The Company operates through business of developing and commercializing vaccines segment. GEN-004 has a unique mechanism of action designed to generate a Th17 T cell-mediated immune response, preventing or reducing pneumococcal colonization in the nasopharynx. Trial data will be further analyzed and detailed results will be submitted for publication.

San Diego-based Otonomy has been closely watched for some time because of its experimental drug for Meniere’s disease, which causes vertigo, hearing loss, and steady ringing in the ears (tinnitus). Additionally, the secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy, which were evaluated by an independent, blinded Adjudication Committee, were similar in both treatment groups. If you have any questions or encounter any issues in changing your default settings, please email isfeedback@nasdaq.com. With the new investment, AnGes’ equity position in Vical will increase from 2.4% to approximately 18.6% of Vical’s outstanding shares. ET. Astellas is conducting the trial, and Vical is providing development, regulatory and manufacturing support. The FDA’s Fast Track program is designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need.

Its focus comprise discovery, research and development of novel antiviral and antibacterial agents in the indications Human Cytomegalovirus, Herpes simplex, HIV, Hepatitis B, and (multi)resistant bacterial infections treated in the hospital. stock quotes reflect trades reported through Nasdaq only.