Moscow, Russia, October 8, 2013 - Dr. Vadim Bichko, Chief Scientific Officer of Viriom, presented positive interim results of Phase Ib/IIa study with VM-1500, a new HIV NNRTI (non-nucleoside reverse transcriptase inhibitor), at the 15th Annual International Meeting of the Institute of Human Virology (held September 8-11, 2013, in Moscow, Russia).
In part I of the trial, a placebo-controlled randomized study of the safety and pharmacokinetics of VM-1500 in healthy volunteers, 12 healthy volunteers were randomized to receive a single oral dose of 20 or 40 mg VM-1500 or placebo. VM-1500 was well-tolerated; no significant adverse events (SAE) were reported.
In part II of the study, the safety, tolerability, and antiviral activity of VM-1500 were assessed in HIV-1 infected patients. A total of 16 HIV-1 infected, treatment-naive subjects were randomized to receive 20 or 40 mg VM-1500 or placebo QD for 7 days. The 20 mg dose was safe and well-tolerated, and no SAEs were reported during VM1500 administration. Pharmacokinetic analyses confirmed high drug exposure and long half-elimination time, supporting once-daily dosing. All 7 HIV-1 infected subjects from the 20 mg cohort achieved strong virologic response with a median HIV RNA reduction of 1.73 log10 IU/ml after 7 days of treatment.
Clinical studies conducted to date demonstrate that VM-1500 is a well-tolerated, safe, and effective HIV NNRTI. An international Phase II study is scheduled to begin in Q1 of 2014.
In 2009, Viriom Ltd. was the first company in Russia to complete a technology transfer licensing arrangement with the Swiss company F. Hoffmann-La Roche, and obtained the rights to develop and manufacture an innovative candidate for treating HIV/AIDS in Russia and the CIS. Viriom completed a program of pre-clinical trials, and is currently conducting a number of clinical trials in Russia and internationally.
Andrey Ivaschenko, Chairman of ChemRar High-Tech Center commented, “This was the first transfer deal involving a big international pharma, where development has been assigned to a Russian company to take [a drug] all the way to manufacturing. Therefore, it is very important that the initial clinical trials support the expectations of the partners, and there is now a significant likelihood that the best drug in this class in the world will be created in Russia.”
Viriom’s development of VM-1500 was among the first projects supported by the Russian Ministry of Industry and Trade under the auspices of the federal targeted program “Development of the Pharmaceutical and Medical Industry in the Russian Federation for the Period of 2020 and beyond”.
Viriom Ltd. is a ChemRar company involved in developing innovative antiviral drugs and combinations, treatment methods, and diagnostics. Viriom conducts scientific research in Russia, using the experience and knowledge of Russian scientists, and abroad within the framework of a broad international partnership. The Viriom project was approved by the Russian President’s Commission on Modernization. The ChemDiv Research Institute is Viriom's major partner in pre-clinical and clinical research. Clinical studies within Russia are conducted at regional centers and on the campus of the Moscow City Center for Preventing and Treating AIDS. Among Viriom’s international partners are Hoffmann-La Roche, Fox Chase Cancer Center (Philadelphia, PA), the Scripps Research Institute (San Diego, CA), the Moscow Physics and Technology Institute, and the M.P. Chumakov Institute for Poliomyelitis and Viral Encephalitis (Moscow, Russia). www.viriom.com
International Virology Week Conference
The applied research conference “International Virology Week” is a global initiative where leading Russian and international scientists meet to discuss the most pressing issues in the development of new antiviral drugs, as well as optimal techniques to diagnose and prevent various viral infections. This year, the conference attracted more than 100 leading virologists from Western Europe and the US.
One of the key themes of the global conference was the fight against HIV infection. According to data from WHO and UNICEF, there are currently around 34 million people infected with HIV; and this number increases annually by around half a million.* Thanks to the latest methods of treatment, it has been possible to reduce mortality significantly; and to increase the length and quality of life of infected patients. But the main problem for world scientists remains the development of a drug that can completely destroy the virus. According to Alexei Mazus, head of the Moscow City Center for Preventing and Treating AIDS, Russia has expertise in working to resolve this issue. This conference was supported by the Moscow Department of Public Health, the Moscow City Center for Preventing and Treating AIDS, the Institute for Human Virology, and the Global Virological Network. www.virologyweek2013.ru
*Global HIV/AIDS Response: epidemic update and health sector progress towards Universal Access: progress Report 2011. Geneva, World Health Organization, 2011