Myeloxen

In 2010 the OJSC "Pharmsynthez" has completed preclinical studies of "Myeloxen", a finished drug for treatment of multiple sclerosis.
The traditional therapy for this disease is limited to application of only one agent - glatiramer acetate. So the actual problem is to create a relatively cheap and effective preparation in order to change the course of the disease. Glatiramer acetate is known under the name "Copaxone" and is produced by the company Teva Ltd., Israel. There are no analogs of this preparation at the market.
Multiple sclerosis is an advanced progressive disease of the central nervous system accompanied by various neurologic symptoms. The disease usually occurs in young and middle age people under the influence of a series of internal and external factors. Multiple sclerosis leads to difficulties in moving up to full paralysis, and difficulties in sensation, as well as to loss of control over neuropsychological conditions. Hundreds of thousands of people suffer from Multiple sclerosis. Therefore it is highly important to find the preparation superior to Glatiramer acetate in ability to correct the immune response to the myelin basic protein.
For this purpose the OJSC "Pharmsynthez" has used up-to-date knowledge in the field of MS pathogenesis as well as modern immunology and nanotechnologies. The result was creation of “Myeloxen”, active pharmaceutical ingredient and finished drug. «Myeloxen» is a lyophilizate for injections, representing peptide vaccine. The active ingredient of the preparation is a set of peptides homologous to immunogenic sites of the myelin basic protein. According to preclinical in vivo studies, the treatment with this preparation is more effective than with "Copaxone". According to studies on experimental animals, "Myeloxen" has no toxic, anaphylactogenic, allergic, immunotoxic, teratogenic and mutagenic properties and doesn’t influence the reproductive function. The quality of the finished drug meets all the requirements of national and international standards and Pharmacopoeias.
The clinical trials and procedure of state marketing authorization of "Myeloxen" preparation are to begin in 2011.