Immunitor Company today announced that the results of the three-year follow-up study of its therapeutic HIV vaccine, V-1 Immunitor (V1), showed a dramatic survival benefit in patients at the final stage of AIDS. Compared to untreated control group V1 has extended life expectancy by nearly sixteen times. The study was just published in a special September issue of Biomedicine and Pharmacotherapy featuring new approaches in chemotherapy and immunotherapy of HIV/AIDS.
(PRWEB) October 3, 2005 -- Immunitor Company today announced that the results of the three-year follow-up study of its therapeutic HIV vaccine, V-1 Immunitor (V1), showed a dramatic survival benefit in patients at the final stage of AIDS. Compared to untreated control group V1 has extended life expectancy by nearly sixteen times. The study was just published in a special September issue of Biomedicine and Pharmacotherapy featuring new approaches in chemotherapy and immunotherapy of HIV/AIDS.
In 2001 as part of a charity program V1 has been offered at a Buddhist hospice for end-stage AIDS patients in Thailand. Out of 117 approached individuals, 53 decided to take V1 and 64 declined the treatment. Patients in both groups did not differ in age, gender, or severity of disease. All patients were in the terminal stage of disease at initiation of study and had received similar palliative care. None of the patients had received conventional antiviral drugs. After nine weeks all patients who refused V1 have died. In contrast, 56.6% in the group that took V1 remained alive. Kaplan-Meier survival estimate showed that median short-term survival time for non-treated and treated patients was 4 and 10 weeks respectively. The difference was statistically significant (p=0.000089).
The preliminary results of this study were first published in 2002 indicating that V1 therapy doubled median survival time. However, at that time long-term survival data due to V1 administration was not known and now this new study reveals the results of a follow-up over a 3-year period. Patients who remained alive resumed normal daily activity and were followed until the last patient died at 142 weeks. Based on the main outcome, time to death, patients who have been treated with V1 had a 15.8 times longer life expectancy than the control group (p=0.000001). As in all previous studies, V1 was extremely well tolerated and had not caused any safety concerns.
"We believe the data from this study is unprecedented and represents the veritable breakthrough since none of currently available treatments can offer such a long survival benefit," said Ms. Orapun Metadilogkul, M.D., director and president of Occupational and Environmental Medicine Association of Thailand and principal investigator of this study. "Survival, rather than surrogate markers like T-lymphocyte counts or viral load, is a single and most straightforward clinical endpoint, defining unequivocally the merit of an anti-HIV therapy. The life-extending benefit combined with excellent safety profile is promising for many AIDS patients in developing countries who have very few treatment options available to them", she added.
In addition to its immunotherapy for AIDS indication, Immunitor's product pipeline also includes product candidates for microbial and fungal infections, H5N1 avian flu vaccine, and cancer vaccine. For more information about the company and its programs, visit www.immunitor.com.
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