-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WykdxSgjVku+K4qu8jvcP0v3NyiY2blf/oYq0I5kwDNv8WONH/8h/1/KS23C4bOg pxtpJOmxVKYU+4J0G2IFbg== 0001036050-98-002119.txt : 19981217 0001036050-98-002119.hdr.sgml : 19981217 ACCESSION NUMBER: 0001036050-98-002119 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19981202 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19981216 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BOSTON LIFE SCIENCES INC /DE CENTRAL INDEX KEY: 0000094784 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 870277826 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-06533 FILM NUMBER: 98770405 BUSINESS ADDRESS: STREET 1: 31 NEWBURY ST STREET 2: SUITE 300 CITY: BOSTON STATE: MA ZIP: 02116 BUSINESS PHONE: 6174250200 MAIL ADDRESS: STREET 1: 31 NEWBURY STREET STREET 2: SUITE 300 CITY: BOSTON STATE: MA ZIP: 02116 FORMER COMPANY: FORMER CONFORMED NAME: GREENWICH PHARMACEUTICALS INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: STRATEGIC MEDICAL RESEARCH CORP /DE DATE OF NAME CHANGE: 19790521 8-K 1 FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported) December 2, 1998 ---------------- BOSTON LIFE SCIENCES, INC. -------------------------- (Exact name of registrant as specified in its charter)
Delaware 0-6533 87-0277826 - ------------------------------- ------ --------------------------------- (State or other jurisdiction of (Commission (I.R.S. Employer incorporation or organization) File No.) Identification No.) 31 Newbury Street, Suite 300 Boston, Massachusetts 02116 - --------------------------------------- ----------------- (Address of principal executive offices) Zip Code
Registrant's telephone number, including area code (617) 425-0200 --------------- Item 5. Other Events. ------------- On December 2, 1998, Boston Life Sciences, Inc. announced the initiation of a preclinical development program for a newly-synthesized "second generation" technetium-based compound, designated O-1506. This compound differs from the Company's first generation compound, Altropane, in structure and in the advantageous substitution of technetium for I123 as the radio-ligand. The Company reported that O-1506 appears to demonstrate selectivity, binding characteristics and brain striatal localization that look outstanding relative to all other reported technetium-based compounds in this class. The Company believes that the introduction of a user-friendly, technetium-based Parkinson's diagnostic product has the potential to substantially increase the market for these agents, particularly in early detection of the disease. The Company will continue to focus on commercialization of Altropane in the United States, while planning to develop O-1506 worldwide because of the potential for simpler manufacturing and distribution considerations. On December 11,1998, the Company announced that results achieved in animal model experiments involving the Company's Central Nervous System (CNS) growth factor, Axogenesis Factor 1 (AF-1), demonstrated re-growth of severed axons within the optic nerve in mice. Since degenerative injury to the optic nerve produces the destruction of vision suffered in glaucoma, the Company believes that these preliminary successes suggest that AF-1 could potentially be used as a treatment for this major cause of blindness in the developed countries. In these experiments, the optic nerves in mice were partially severed and the mice were then treated with one injection of AF-1 administered into the posterior chamber of the eye. Treated animals showed histologic evidence of substantial optic nerve regeneration across the lesion, whereas control animals showed insignificant or no evidence of regeneration in their optic nerves. The Company noted that a significant amount of additional work needs to be done to confirm and elaborate these preliminary results as well as optimize drug delivery and dosing. Item 7. Exhibits. -------- The following Exhibits are filed as part of this report on Form 8-K: 99.1 Press Release, dated December 2, 1998. 99.2 Press Release, dated December 11, 1998. 1 SIGNATURES - ---------- Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto authorized. BOSTON LIFE SCIENCES, INC. Dated: December 14, 1998 By: /s/Joseph Hernon ---------------- Joseph Hernon Chief Financial Officer 2 BOSTON LIFE SCIENCES, INC. CURRENT REPORT ON FORM 8-K EXHIBIT INDEX Exhibit No. Page(s) - ----------- ------- 99.1 Press Release, dated December 2, 1998 4 99.2 Press Release, dated December 11, 1998 5 3 EX-99.1 2 PRESS RELEASE, DATED DECEMBER 2,1998 Exhibit 99.1 FOR IMMEDIATE RELEASE --------------------- BOSTON LIFE SCIENCES BROADENS PROMINENT POSITION IN DEVELOPMENT OF DIAGNOSTIC AGENTS FOR PARKINSON'S DISEASE DECEMBER 2, 1998--BOSTON, MA. BOSTON LIFE SCIENCES, INC. (NASDAQ: BLSI) whose compound, Altropane/tm/ is the only diagnostic agent for Parkinson's Disease currently in active advanced human clinical trials, announced that it has initiated a preclinical development program for a newly-synthesized "second generation" technetium-based compound (designated O-1506). This compound differs from Altropane in structure and in the advantageous substitution of technetium for I/123/ as the radio-ligand. "In both in vitro and in vivo studies, O-1506 appears to demonstrate selectivity, binding characteristics, and brain striatal localization that look outstanding relative to all other reported technetium-based compounds in this class," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. "Even as Altropane continues to perform exceedingly well in our clinical trials, we believe that the subsequent introduction of a user-friendly, technetium-based Parkinson's diagnostic product has the potential to substantially increase the market for these agents, particularly in early detection of the disease. The ability to eventually follow Altropane to market, if approved, with a second- generation technetium product would, in our view, give BLSI a long-term competitive advantage in this rapidly emerging diagnostic area. While our priority is to continue to focus on commercialization of Altropane in the U.S., we plan to develop O-1506 worldwide because of potentially simpler manufacturing and distribution considerations," added Dr. Lanser. The foregoing contains forward-looking statements with regard to product development timelines and regulatory filings, which may not be realized due to the uncertainties inherent in the research and development process. BLSI is developing novel treatments for cancer, autoimmune disease, and central nervous system disorders. In addition to Altropane and O-1506, products awaiting FDA review, in clinical trials or in preclinical development by BLSI include THERAFECTIN for the treatment of Rheumatoid Arthritis; AF1 for the potential treatment of stroke and spinal cord injury; Troponin, an anti-angiogenic treatment for cancer and eye diseases, and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies. For further information please contact: Marc E. Lanser, MD Chief Scientific Officer 617/425-0200 4 EX-99.2 3 PRESS RELEASE, DATED DECEMBER 11, 1998 Exhibit 99.2 FOR IMMEDIATE RELEASE --------------------- BOSTON LIFE SCIENCES' NERVE GROWTH FACTOR DEMONSTRATES POTENTIAL AS A NEW TREATMENT FOR GLAUCOMA BOSTON, MA--DECEMBER 11, 1998. BOSTON LIFE SCIENCES, INC. (NASDAQ: BLSI) announced that results achieved in animal model experiments involving the Company's Central Nervous System (CNS) growth factor Axogenesis Factor 1 (AF1) demonstrated re-growth of severed axons within the optic nerve in mice. Since degenerative injury to the optic nerve produces the destruction of vision suffered in glaucoma, these preliminary successes suggest that AF1 could potentially be used as a treatment for this major cause of blindness in the developed countries, the Company said. "To our knowledge, this is the first time that optic nerve regeneration has reportedly been achieved by intraocular injection of a single nerve growth factor. In these experiments, the optic nerves in mice were partially severed and the mice were then treated with one injection of AF1 administered into the posterior chamber of the eye. Treated animals showed histologic evidence of substantial optic nerve regeneration across the lesion, whereas control animals showed insignificant or no evidence of regeneration in their optic nerves. Though much work needs to be done to confirm and elaborate these preliminary results as well as optimize drug delivery and dosing, these exciting data suggest that AF1 has the potential to be a totally novel approach to the treatment of glaucoma," stated Dr. Marc E. Lanser, MD, Chief Scientific Officer of BLSI. "This important in vivo activity of AF1 is consistent with both our prior in vitro data demonstrating the potent axon regenerative activity of AF1, and significantly complements our recently reported positive results in experimental spinal cord axonal regeneration. The Company's CEO, David Hillson commented, "Coming on top of our previously reported positive results for Troponin as an anti-angiogenic approach to the treatment of macular degeneration and diabetic retinopathy, we will want to include our CNS program for consideration by potential ophthalmic partners. Given our assessment of the importance of both of these recent experimental successes, we now believe that the value of our CNS program could potentially achieve equal status with our more well-known technologies." BLSI is developing novel treatments for cancer, autoimmune disease, and central nervous system disorders. Products awaiting FDA review, in clinical trials or in preclinical development by BLSI include THERAFECTIN for the treatment of Rheumatoid Arthritis; AF1 and other nerve growth factors for the potential treatment of stroke and spinal cord injury; Altropane, a radioimaging agent for the diagnosis of Parkinson's Disease; Troponin as an anti-angiogenic treatment for cancer, and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies. The foregoing contains forward-looking statements with regard to product development timelines, the implication of experimental results and eventual clinical indications, any of which may not result in approved products due to the uncertainties inherent in the research and development process. For further information please contact: Marc E. Lanser, MD Chief Scientific Officer 617-425-0200 5 -----END PRIVACY-ENHANCED MESSAGE-----