Peptimmune Initiates Trial Of PI-2301 In Multiple Sclerosis Patients

Peptimmune, Inc a private biotechnology company, announced today that the doctors treated the first participant in a clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in patients with secondary progressive MS (SP-MS). PI-2301 is a new peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.
Phase Ib multiple ascending dose, double-blind, placebo-controlled, randomized study will include up to fifty-three subjects with SP-MS, who will receive the drug once a week for four doses escalating cohorts. After you create security for potentially therapeutic doses and proof of pharmacologic mechanism, the company plans to begin its Phase II study in patients with multiple sclerosis in early 2009.
PI-2301 is a second generation peptide copolymer from a similar class of compounds in the form of Copaxone (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response to the immune system and thereby control of pathogenic autoimmune response observed in some disease. In one step of increasing the dose, double-blind, placebo-controlled, randomized study, all doses of PI-2301 was safe and well tolerated and no serious side effects were observed. Pharmacodynamic assays demonstrated evidence of immune exposure in accordance with the pharmacologic mechanism of action for PI-2301, and a dose-dependent pharmacokinetics was observed.
PI-2301 has been optimized using the new platform Peptimmune peptide chemistry and in preclinical studies, showed a much more powerful and effective than Copaxone in treating disease models of multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases in which immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has introduced a high-quality synthesis and analytical methods that provide the highest level from batch to batch reproducibility in the production of PI-2301.
More than 400,000 Americans with multiple sclerosis (MS), MS, and may affect more than 2.5 million people worldwide. MS an autoimmune disease in which the immune system reacts against individuals of several components of nerve-insulating myelin. The effects of these immune attack can range from relatively benign to somewhat disabling to devastating as communication between the brain and other parts of the body is disturbed.

New Compounds May Lead to Treatments for Ebola, Marburg Viruses

There is currently no vaccine or effective treatment of Ebola and Marburg filoviruses, two deadly viruses that cause hemorrhagic fever, but a new discovery of U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and AVI BioPharma could lead to the first vaccine may protect against viruses that have a 90% mortality in humans.PMO compounds block viral replication in animal studies
Travis K. Warren Research and his colleagues have found two compounds from a family known as antisense phosphorodiamidate morpholio oligomers, or in the PMO. These compounds block critical genetic viral sequences, viral replication to stop long enough to give the immune system time to protect against viruses and remove it from the body.
Nine monkeys exposed to Ebola virus, and eight of them received PMO compound called AVI-6002. The compound is protected 60% of monkeys infected with Ebola virus. In the second experiment, three of the five monkeys in each group survived at a dose of 40 mg of AVI-6002 per kilogram of body weight.
A second compound called PMO AVI-6003 protected 100% of the monkeys infected with Marburg virus Lake Victoria (Merv). Furthermore, it was more than 90% effective in mice and guinea pigs.

Both compounds appeared to protect animals when administered up to one hour after exposure, suggesting they may also be used to treat people who accidentally become infected in laboratories and hospital.
Ebola and Marburg viruses are usually transmitted through blood and body fluids. However, infection can occur through droplets, causing serious concern as a potential weapon in biological warfare or terrorism.
The researchers presented new applications of the study drug (IND) for AVI-6002 and AVI-6003, to U.S. Food and Drug (FDA) and are clinically tested on a small group of volunteers man.
According to the UN World Health Organization (WHO), about 1850 cases of Ebola have occurred since 1976, resulting in approximately 1,200 deaths.