The experiment will test the level of effective doses in schizophrenia patients - Phase IIa results of the clinical tests are expected to be received during the fourth quarter of 2007
The drug development company, Bioline RX, announced today the start of phase II clinical trials in schizophrenia patients to evaluate the optimal dose in patients of BL-1020, an innovative molecule for the treatment of schizophrenia.
"This is an important milestone in the history of Bioline and the development of BL-1020," said Dr. Maurice Lester, CEO of Bioline R.X. "The dosage in the phase II trial is based on previous clinical trials, which were conducted on healthy volunteers. In light of the results of the trials so far, we believe that BL-1020 has the potential to be effective and at the same time cause minimal side effects. We look forward to the Phase IIa results of the clinical trials expected to be received next quarter."
The experiment is expected to be conducted in 5 centers in Israel and 12 centers in Romania for 6 weeks. The main goal of the experiment is to determine the effective doses in patients of two doses of the drug in 60 schizophrenia patients and patients suffering from schizo-affective disorder.
In preparation for the Phase II trial, Beauline R. Ex. An international conference of researchers held in Jerusalem on June 14-18. Seventy psychiatrists and medical teams from 17 centers in Israel and Romania participated in a conference designed to train them for the clinical research. During the conference, the researchers were introduced to the drug, learned the trial protocol and underwent training and refresher procedures and various psychiatric questionnaires.
Professor Michael Davidson, director of the psychiatry department at Sheba Medical Center, said, "There is a clear need for new antipsychotic drugs that will be more effective and better tolerated by patients. The existing drugs are indeed effective, but the patients' response to the drug is impaired due to the side effects. Phase I human clinical trials have shown that BL-1020 has an excellent safety profile and maintains a good level of efficacy. We would be happy to test this new molecule on schizophrenia patients."
About BL-1020
BL-1020 is an antipsychotic drug taken by mouth to treat schizophrenia. According to tests conducted in models of schizophrenia in laboratory animals and in phase I of clinical tests in humans, it was found that the drug is effective in treating the symptoms of the disease and at the same time significantly reduces the degree of side effects compared to the drugs accepted for the treatment of this disease.
The rights for BL-1020 were purchased from the technology commercialization companies, Ramot Company of Tel Aviv University and the Research and Development Company of Bar Ilan University. The drug is the product of the invention of Professor Avraham Nodelman from the Department of Biochemistry at Bar Ilan University, and Dr. Ada Rafali, Professor Avraham Weizman and Dr. Irit Gil-Ed from the Sackler Faculty of Medicine at Tel Aviv University.
About schizophreniaSchizophrenia is a serious mental illness that affects about 1% of the world's population. It is a disease characterized by delusions and hallucinations, emotional detachment and apathy, and poor attention and level of organization. In 2002, the total cost of treating schizophrenia in the US was estimated at $62.7 billion, and the US market for schizophrenia drugs is expected to reach $10 billion in 2012.
