antiquity
02-25-2002, 11:16 AM
Boston Life Sciences Completes Chemical and Biological Equivalence Testing for Its Parkinson's Diagnostic ALTROPANE
BOSTON--(BW HealthWire)--Feb. 25, 2002--
Company incorporates results of testing in pre-NDA Briefing Document
submitted to FDA
Boston Life Sciences, Inc. (NASDAQ: BLSI) announced that it has completed the testing it believes is necessary to document the chemical and biologic equivalence of the commercial supply of the Company's product candidate for the diagnosis of Parkinsonian Syndromes, ALTROPANE(TM), to that used in its clinical trials of the drug. These studies were necessitated by the change of manufacturer and process from clinical trial scale to full cGMP commercial scale. The results of these equivalency studies revealed no detectable differences in chemical or biologic properties between the two sources of material, the Company said.
"Although it took more time than we anticipated to complete the testing, we are pleased with the results, and have incorporated them in the pre-NDA Briefing Document the Company has submitted to the FDA," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. In connection with that submission, Dr. Lanser added that the Company has requested a teleconference with the FDA to discuss, among other things, the scheduling of a pre-NDA meeting. The Company hopes this meeting will be held during the second quarter.
BLSI is developing novel diagnostics and therapeutics for Parkinson's Disease (PD) and Attention Deficit Hyperactivity Disorder (ADHD) as well as treatments for cancer, autoimmune disease, and central nervous system disorders. BLSI's products in development include: ALTROPANE(TM) and FLUORATEC(TM) radioimaging agents for the diagnosis of PD and ADHD; Troponin I, a naturally-occurring anti-angiogenesis factor for the treatment of solid tumors; AF-1 and Inosine, nerve growth factors for the treatment of acute and chronic CNS disorders;novel therapies for the treatment of PD and ADHD; and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies.
Statements made in this press release other than statements of historical fact represent forward-looking statements. Such statements include, without limitation, statements regarding expectations or beliefs as to future results or events, such as the expected timing and results of clinical trials, discussions with regulatory agencies, schedules of IND, NDA and all other regulatory submissions, the timing of product introductions, the possible approval of products, and the market size and possible advantages of the Company's products. All such forward-looking statements involve substantial risks and uncertainties, and actual results may vary materially from these statements. Factors that may affect future results include: the availability and adequacy of financial resources, the ability to obtain intellectual property protection, delays in the regulatory or development processes, results of scientific data from clinical trials, the outcome of discussions with potential partners, regulatory decisions, market acceptance of the Company's products, and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K.
CONTACT:
Boston Life Sciences, Inc.
Marc Lanser
617.425.0200
mlanser@bostonlifesciences.com
[This message was edited by seneca on Feb 26, 2002 at 04:24 AM.]
[This message was edited by seneca on Feb 26, 2002 at 04:26 AM.]
[This message was edited by seneca on Feb 26, 2002 at 04:27 AM.]
BOSTON--(BW HealthWire)--Feb. 25, 2002--
Company incorporates results of testing in pre-NDA Briefing Document
submitted to FDA
Boston Life Sciences, Inc. (NASDAQ: BLSI) announced that it has completed the testing it believes is necessary to document the chemical and biologic equivalence of the commercial supply of the Company's product candidate for the diagnosis of Parkinsonian Syndromes, ALTROPANE(TM), to that used in its clinical trials of the drug. These studies were necessitated by the change of manufacturer and process from clinical trial scale to full cGMP commercial scale. The results of these equivalency studies revealed no detectable differences in chemical or biologic properties between the two sources of material, the Company said.
"Although it took more time than we anticipated to complete the testing, we are pleased with the results, and have incorporated them in the pre-NDA Briefing Document the Company has submitted to the FDA," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. In connection with that submission, Dr. Lanser added that the Company has requested a teleconference with the FDA to discuss, among other things, the scheduling of a pre-NDA meeting. The Company hopes this meeting will be held during the second quarter.
BLSI is developing novel diagnostics and therapeutics for Parkinson's Disease (PD) and Attention Deficit Hyperactivity Disorder (ADHD) as well as treatments for cancer, autoimmune disease, and central nervous system disorders. BLSI's products in development include: ALTROPANE(TM) and FLUORATEC(TM) radioimaging agents for the diagnosis of PD and ADHD; Troponin I, a naturally-occurring anti-angiogenesis factor for the treatment of solid tumors; AF-1 and Inosine, nerve growth factors for the treatment of acute and chronic CNS disorders;novel therapies for the treatment of PD and ADHD; and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies.
Statements made in this press release other than statements of historical fact represent forward-looking statements. Such statements include, without limitation, statements regarding expectations or beliefs as to future results or events, such as the expected timing and results of clinical trials, discussions with regulatory agencies, schedules of IND, NDA and all other regulatory submissions, the timing of product introductions, the possible approval of products, and the market size and possible advantages of the Company's products. All such forward-looking statements involve substantial risks and uncertainties, and actual results may vary materially from these statements. Factors that may affect future results include: the availability and adequacy of financial resources, the ability to obtain intellectual property protection, delays in the regulatory or development processes, results of scientific data from clinical trials, the outcome of discussions with potential partners, regulatory decisions, market acceptance of the Company's products, and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K.
CONTACT:
Boston Life Sciences, Inc.
Marc Lanser
617.425.0200
mlanser@bostonlifesciences.com
[This message was edited by seneca on Feb 26, 2002 at 04:24 AM.]
[This message was edited by seneca on Feb 26, 2002 at 04:26 AM.]
[This message was edited by seneca on Feb 26, 2002 at 04:27 AM.]