Schizophrenia Daily News Blog

New GABA-targeted Schizophrenia Medication in Phase II Clinical Trials - BioLineRX

BioLineRx Initiates Phase II Trial of a GABA-Enhanced Antipsychotic Medication Designed for the Treatment of Schizophrenia; Results of Phase IIa Trials Expected Q4 2007.

The following news story is about a new medication that is being tested by an Israeli company. The new medication is entering what is called "Phase II" testing of the three-stage FDA new medication approval process. It is still early in the testing process so it is unknown at this time if this medication will pass all these tests and be proven to be both safe and effective. It is, however, important in that it demonstrates that researchers are working on new medications that early testing has suggested will be improvements over the older medications. Stay tuned for future news on this, and other medications. It will likely be another 3 or 4 years before this specific medication will be proven effective or not.

Marketing/Press release from BiolineRX:

BioLineRx Ltd. an Israeli drug development company, today announced the initiation of a Phase II clinical trial on schizophrenic patients for the maximal tolerated dose determination of BL-1020. BL-1020 is a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.

"The dose ranges in this Phase II trials are based on results in previous clinical studies, which were performed on healthy volunteers. Based on our previous results, we believe that BL-1020 has the potential to be clinically efficacious with minimal therapy-limiting side effects. We very much look forward for the results of these Phase IIa trials expected sometime during the fourth quarter of 2007." commented Morris C. Laster, MD, chief executive officer of BioLineRx.

The trial is designed as an open-label, multi-center, 6-week, sequential cohort study which is expected to be conducted in 5 centers in Israel and 12 centers in Romania. The primary objective of the study is to determine the maximal tolerated dose of BL-1020 in 60 patients with schizophrenia or schizo-affective disorder.

"There is a clear need for new antipsychotic drugs with increased efficacy and better tolerability, as currently available drugs while effective have patient compliance issues related to the drugs' side effect profile," said Professor Michael Davidson, Director Department of Psychiatry, Sheba MedicalCenter and the principal medical advisor of the trial. "Phase I studies have shown a very favorable safety profile for BL-1020, while retaining efficacy. We are looking forward to testing this novel compound on patients with schizophrenia."

About BL-1020

BL-1020 is an orally available GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia. Data from preclinical and phase I studies demonstrated that the compound may retain the efficacy of currently available typical and atypical antipsychotic drugs while achieving a much higher safety profile as evidenced by a lack of metabolic or extrapyramidal side effects.

BL-1020 is being developed by BioLineRx, Ltd. under a worldwide exclusive license from Ramot at Tel Aviv University Ltd. and Bar-Ilan Research and Development Company Ltd., the technology transfer arms of Tel Aviv University and Bar-Ilan University respectively.

About Schizophrenia

Schizophrenia is a serious mental disorder that affects about 1% of the world's population. It is a multifactorial disease characterized by delusions and hallucinations, emotional withdrawal and apathy,poor attention and disorganization. In 2002, the overall cost of schizophrenia in the United States was estimated at $62.7 billion, and the market for schizophrenia therapy in the U.S. is estimated to reach approximately $10 billion in 2012.