The results are expected to be received in the third quarter of 2009 * The company moved two months ahead of the original date planned for the completion of the recruitment of all 360 schizophrenia patients * CEO Dr. Maurice Lester: "We are encouraged by the rapid rate of recruitment of patients for the trial which is usually a tremendous obstacle in completing a trial of this magnitude "
Bioline R.X., a drug development company with products in advanced clinical and pre-clinical development stages, completed the recruitment of 360 schizophrenia patients as part of the second phase (2b) of the clinical trials for the evaluation of BL-1020, an innovative drug for the treatment of schizophrenia. In doing so, the company was able to advance by two months the original date set for the completion of the recruitment of patients. In July 2008, Bioline R.X. began phase 2b clinical trials in schizophrenia patients to evaluate the efficacy, safety, and tolerability of BL-1020.
Schizophrenia is a serious mental illness that affects about 1% of the world's population. It is a disease characterized by false thoughts and hallucinations, emotional detachment and apathy, poor attention and level of organization. Schizophrenia is the most common serious mental illness: 24 million people suffer from schizophrenia worldwide. In 2002, the total cost of treating schizophrenia in the US alone was estimated at $62.7 billion, and the US market for schizophrenia drugs is expected to reach $10 billion in 2012.
The trial was conducted under an IND approval received from the American Food and Drug Administration (FDA), and took place in the USA, Romania and India with the aim of proving that BL-1020 has the potential to be a new generation antipsychotic drug that will be effective and have minimal side effects.
As part of the experiment, the patients were randomly divided into four groups: two groups that were treated with a low or high dose of BL-1020, a group that was treated with risperidone, which is an approved drug for the treatment of schizophrenia, and an Invo (placebo) group. Each patient received the drug for six weeks. The purpose of the experiment was to test the effectiveness and safety of BL-1020 in different doses - in comparison to ibuprofen and risperidone. The drugs available today are not always effective and in addition cause severe side effects such as metabolic changes such as obesity and diabetes and motor side effects such as Parkinson's-like symptoms.
Dr. Morris Lester, CEO of Bioline R.X., states that "We are happy to report that 100% of patients have been recruited for the BL-1020 clinical trial, which is earlier than we first estimated. Completing the recruitment of patients means that within 6 weeks from today the experiment will end and within a few months we will be informed of the results of the experiment. We are encouraged by the rapid rate of recruitment of patients, which is usually a huge obstacle in completing a trial of this magnitude. In addition, an independent committee to check the safety of the experiment has already examined the first 50 patients and approved the continuation of the experiment and the recruitment of the rest of the patients since no unusual side effects were found. We are also very encouraged by the very low dropout rate of the patients in the trial relative to what is accepted in other trials in the field."
Dr. Lester also said that "We hope that BL-1020 will significantly improve the quality of treatment for patients suffering from schizophrenia, and we look forward to the results of phase 2b of the trials to be received in the third quarter of 2009. In accordance with the business model of Bioline R.X., we hope that the results of the trial will form the basis for cooperation with an international pharmaceutical company that has the resources and expertise needed to complete the development and marketing of BL-1020, for the well-being of schizophrenia patients."
Today there are two groups of antipsychotic drugs: the classic or typical (typical), which are drugs of the old generation, and atypical (atypical) drugs of a newer generation. In both groups, the patients' response to treatment was limited due to the many side effects of the drugs. The typical antipsychotic drugs cause motor side effects, while the atypical drugs cause metabolic changes including obesity, adult diabetes and changes in the distribution of adipose tissue.
About BL-1020
The BL-1020 drug for the treatment of schizophrenia can be taken by mouth. Previous clinical trials conducted there have shown that BL-1020 is effective without causing motor or metabolic side effects that limit the use of existing drugs. The results of phase 2a clinical trials for BL-1020 in schizophrenia patients showed an improvement in efficacy and safety without significant changes in body weight or the level of motor symptoms. In addition, animal experiments - showed significant improvements in cognition (level of thought) - a clear medical need that still has no answer in schizophrenia patients.
The rights for BL-1020 were purchased under an exclusive and worldwide license 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 Beauline R. Ex.
Beauline R. X., a drug development company with products in advanced clinical and pre-clinical development stages, traded on the Tel Aviv Stock Exchange, focuses on building a drug pipeline for existing medical needs. The company's leading drugs are BL-1020 for the treatment of schizophrenia and BL-1040 for the treatment of damaged heart tissue due to myocardial infarction. Other products in development include drugs for the treatment of cancer, and diseases of the central nervous system, heart, metabolism, inflammatory and autoimmune diseases.
The company works to promote medicines from the early stages of development, through the stages of pre-clinical and advanced clinical trials. By collaborating with researchers, universities and biotechnology companies, Bioline R. X aims to enrich the drug pipeline of global pharmaceutical companies. The company was founded in 2003 by leading parties in the field of life sciences in Israel, including Teva, the venture capital funds Giza and Pitango, Hadasit and the Jerusalem Development Authority.
