The safety and efficacy study of this drug at seven clinical centres in the country is expected to enroll up to 40 patients with Glioblastoma who have experienced their first relapse. The Indian trial is part of Peregrine's overall Cotara brain cancer development program worldwide.
The office of Drug Controller General of India has confirmed that the Peregrine's global trial application has been cleared for clinical development studies in India and the trials may be started shortly at the selected centers.
The Tustin-based Peregrine Pharmaceuticals is a leader in biopharmaceutical research and developer of potential cancer and hepatitis C treatments, has a portfolio of innovative clinical stage and pre-clinical product candidates for the treatment of cancer and viral diseases.
Its anti-viral Bavituximab is currently in Phase I studies for hepatitis C infection and pre-clinical studies in influenza and other life-threatening viral infections and bavituximab anti-cancer is in a Phase I trial for solid tumor cancers at present.
It is learnt that that a leading clinical research organisation, which has strong presence in India, has been assigned to initiate trials of this novel brain cancer drug trials in the country.
Cotara is an experimental new treatment for brain cancer that links a radioactive substance designed for medical uses -- a radioactive isotope -- to a targeted monoclonal antibody. This monoclonal antibody is designed to bind to a type of DNA that is exposed only on dead and dying cells.
Solid tumors, including brain tumors, have a significant number of dead and dying cells at their center, and Cotara's targeting mechanism enables it to home in on these dying tumor cells, delivering its radioactive "payload" directly to these cells at the center of the tumor mass.
Cotara thus literally destroys the tumor "from the inside out" with minimal radiation exposure to healthy tissue.
The drug is delivered through a special method called convection-enhanced delivery, which uses a catheter to bypass the blood brain barrier and target the specific tumor site in the brain, directing Cotara to the tumor more precisely.
This type of delivery has been shown to achieve up to a 10,000-fold greater concentration in local therapy exposure than conventional intravenous drug administration, while minimising unwanted exposure.
In previous clinical studies Cotara has demonstrated encouraging results in a number of patients with advanced brain cancer. One study demonstrated a greater than 50 per cent increase in median survival time in a group of patients suffering from late stage glioblastoma multiforme who were treated with Cotara.
This was considered a promising development in this serious and deadly disease. The new trial aims to provide clinical data in a timely manner that can be combined with the dosimetry and safety data we will be gathering from the ongoing US study to guide the further clinical and commercial development of Cotara, said sources.
According to sources, since Peregrine has opted for including India also in its global trial, it is expected that the company my be introducing this drug in the country after the successful completion of the studies.