Boston Life Sciences Announces Results of its Phase III Trial for Therafectin.BOSTON--(BUSINESS WIRE)--Sept. 30, 1997--Boston Life Sciences Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BLSI BLSI Boston Life Sciences, Inc. ) announced the results of its double-blind, placebo-controlled Phase III trial of Therafectin(R) for the treatment of Rheumatoid Arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. (RA). The primary efficacy variable was "Therapeutic Success", defined as a return to baseline or better in the number of painful joints, swollen joints, and global assessments at the final visit. The secondary efficacy variables were the number of painful joints, the number of swollen joints, the patient's global assessment, and the physician's global assessment (among others). The results were analyzed on an Intent to Treat (ITT ITT Initial Teacher Training (UK) ITT I Think That ITT Invitation To Tender ITT Individual Time Trial (professional cycling) ITT Intention-To-Treat ITT In This Thread (forums) ), Last Observation Brought Forward (LOBF) basis. Preliminary analysis of the results did not demonstrate a statistically significantly difference between Therafectin and placebo in the percentage of patients achieving "Therapeutic Success", the company said. Forty percent of patients receiving Therafectin and 33 percent of patients receiving placebo achieved "Therapeutic Success". The company also noted that in centers that enrolled at least ten patients, 48 percent of Therafectin patients achieved "Therapeutic Success" as compared to placebo patients who achieved "Therapeutic Success" in 29 percent of cases. Among the secondary efficacy variables, the improvement in the number of swollen joints in patients receiving Therafectin was, however, highly statistically significantly better than in those patients receiving placebo (p less than 0.007). Consistent with the previously established excellent safety profile of Therafectin, there were no significant adverse events attributable to the drug during the course of the study, the company said. "While Therafectin once again performed better than placebo, we are obviously disappointed that the primary endpoint fell short of statistical significance," said Marc Lanser, MD, Chief Scientific Officer of BLSI. "In view of the excellent safety profile of Therafectin, and the previous statistically significant successful trial combined with at least three supportive trials, we think it is responsible and prudent for us to seek input and advice from an advisory panel of rheumatologists that we will assemble to help us determine whether to proceed with a submission of an amendment to the pending NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any seeking approval for the drug." David Hillson, president of BLSI added, "We gave this drug the additional clinical trial that we felt it deserved, given its superior safety profile and previous trial results. We expect to have further comment regarding our future plans for Therafectin following receipt of input from our newly assembled advisory panel. "Our focus remains on the development of all of the products in the original BLSI portfolio. These include Altropane, our Parkinson's Disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. diagnostic imaging agent which is projected to complete clinical trials in the first half of 1998; Troponin troponin /tro·po·nin/ (tro´po-nin) a complex of muscle proteins which, when combined with Ca2+, influence tropomyosin to initiate contraction. tro·po·nin n. , our anti-angiogenic agent for which an IND filing is planned for the first half of 1998; Axogenesis Factor 1, our Central Nervous System growth factor; and C-Maf, a novel T-cell switch factor. The cost to BLSI of the Therafectin trial was approximately $3.5 million. We believe that our current cash is adequate to sustain the company's current R&D programs through 1999." The foregoing contains certain forward-looking statements with regard to projected or estimated dates for submission of certain regulatory filings and completion of certain stages of product development which may not be realized due to the uncertainties inherent in the research and development and regulatory processes. BLSI is developing novel treatments for cancer, autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause , and central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . In addition to THERAFECTIN, BLSI's products in clinical trials or in preclinical development include Troponin I troponin I n. A subunit of troponin found in muscle and cartilage that inhibits the formation of blood vessels and is under investigation as a potential cancer therapy. , a natural anti-angiogenesis factor for the treatment of solid tumors; Axogenesis Factor 1 (AF-1), a novel Central Nervous System growth factor; Altropane, a radioimaging agent for the diagnosis of Parkinson's Disease; and transcription factors that may control the expression of molecules associated with autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma and allergies. CONTACT: Marc E. Lanser, MD Chief Scientific Officer S. David Hillson President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 617/425-0200 or Martin E. Janis & Co. Inc. Bev Jedynak 312/943-1100 |
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