-----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, MqPQx34PbZe3lAO63+wBmA8s3sHBoDfFbjQMoXGKrYf4E3ncl1oevfVtJdFoszLu I1o4QwVlcX+5mxebsj31oQ== 0001036050-98-001231.txt : 19980803 0001036050-98-001231.hdr.sgml : 19980803 ACCESSION NUMBER: 0001036050-98-001231 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19980701 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19980729 SROS: NASD 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: 98672917 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 (DATED 07/01/98) 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) July 1, 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 Identification No.) incorporation or organization) File 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 July 1, 1998, Boston Life Sciences, Inc. announced that it had submitted an amendment to the pending NDA for THERAFECTIN. The amendment is comprised of the results of the Company's Phase III trial of THERAFECTIN as well as the manufacturing data pertaining to the clinical supplies used in the study. The results of the trial had previously been summarized in a January 20, 1998 Company Press Release. The Company has requested marketing approval based on the results of the trial and the previous data contained in the THERAFECTIN NDA. THERAFECTIN is a carbohydrate-based small molecule that has been developed as an oral treatment of Rheumatoid Arthritis. The Company believes, based on its favorable safety profile and convenient oral dosing, that THERAFECTIN, if approved, could receive significant market acceptance. On July 14, 1998, Boston Life Sciences, Inc. announced that in animal studies, BLSI's anti-angiogenic product Troponin I appeared to inhibit blood vessel formation in an animal eye model of retinal neovascularization. Prior animal studies had also indicated that Troponin inhibited metastatic tumor growth. A single intra-ocular injection of Troponin significantly inhibited retinal angiogenesis in this model. The Company considers these results highly encouraging, since it did not optimize either dosing or delivery of Troponin to the retina in these experiments. Based on these results, the Company hopes to move forward as rapidly as possible with the development of Troponin for the potential treatment of Macular Degeneration and Diabetic Retinopathy, two important angiogenic eye diseases affecting millions of individuals. Discussions with potential corporate partners to co-develop these and potentially other ophthalmic indications are ongoing, although no specific agreements have yet been reached. BLSI is developing novel treatments for cancer, autoimmune diseases, and central nervous system disorders. Item 7. Exhibits. -------- The following Exhibits are filed as part of this report on Form 8-K: 99.1 Press Release, dated July 1, 1998. 99.2 Press Release, dated July 14, 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: July 27, 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 July 1, 1998 4 99.2 Press Release, dated July 14, 1998 5 3 EX-99.1 2 NEWS RELEASE (DATED 7/1/98) Exhibit 99.1 FOR IMMEDIATE RELEASE --------------------- BOSTON LIFE SCIENCES ANNOUNCES SUBMISSION OF NDA AMENDMENT FOR THERAFECTIN/R/ Boston, MA--July 1, 1998. Boston Life Sciences, Inc. (NASDAQ: BLSI) announced that it had submitted an amendment to the pending NDA for THERAFECTIN. The amendment is comprised of the results of the Company's Phase III trial of THERAFECTIN as well as the manufacturing data pertaining to the clinical supplies used in the study. The results of the trial had previously been summarized in a January 20, 1998 Company Press Release. The Company has requested marketing approval based on the results of the trial and the previous data contained in the THERAFECTIN NDA. THERAFECTIN is a carbohydrate-based small molecule that has been developed as an oral treatment of Rheumatoid Arthritis. "We believe, based on its favorable safety profile and convenient oral dosing, that THERAFECTIN, if approved, would receive significant market acceptance", said Marc Lanser, MD, Chief Scientific Officer at BLSI. BLSI is developing novel treatments for cancer, autoimmune disease, and central nervous system disorders. In addition to THERAFECTIN, products in clinical trials or in preclinical development by BLSI include Troponin I, a naturally- occurring anti-angiogenesis factor for the potential treatment of solid tumors; AF1 for the potential treatment of stroke and spinal cord injury; 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 and allergies. This press release contains forward-looking statements regarding market prospects for THERAFECTIN. Actual results may vary materially, and there can be no assurance that regulatory approval will be obtained, or that if obtained, that THERAFECTIN will receive significant market acceptance. For additional information contact: David Hillson President and CEO 617-425-0200 4 EX-99.2 3 NEWS RELEASE (DATED 7/14/98) Exhibit 99.2 FOR IMMEDIATE RELEASE --------------------- BOSTON LIFE SCIENCES' ANTI-ANGIOGENIC TROPONIN IS SHOWN IN ANIMAL STUDIES TO INHIBIT RETINAL ANGIOGENESIS Boston, MA --July, 14, 1998. Boston Life Sciences, Inc. (NASDAQ: BLSI) announced that in animal studies, BLSI's anti-angiogenic product Troponin I appeared to inhibit blood vessel formation in an animal eye model of retinal neovascularization. Prior animal studies had also indicated that Troponin inhibited metastatic tumor growth. A single intra-ocular injection of Troponin significantly (p less than 0.0005) inhibited retinal angiogenesis in this model. "In addition to our gratifying results in the treatment of cancer, we are pleased to have received further evidence of Troponin's potent anti-angiogenic activity in an additional model of angiogenesis", stated Marc Lanser, MD, Chief Scientific Officer of BLSI. "We consider these results highly encouraging, since we did not optimize either dosing or delivery of Troponin to the retina in these experiments. Therefore in addition to development for cancer applications, we hope to move forward as rapidly as possible with the development of Troponin for the potential treatment of Macular Degeneration and Diabetic Retinopathy, two important angiogenic eye diseases affecting millions of individuals. Discussions with potential corporate partners to co-develop these and potentially other ophthalmic indications are ongoing, although no specific agreements have yet been reached," said Dr. Lanser. BLSI is developing novel treatments for cancer, autoimmune disease, and central nervous system disorders. In addition to Troponin I, a naturally-occurring anti-angiogenesis factor for the potential treatment of solid tumors and eye diseases, products under FDA review, in clinical trials or in preclinical development by BLSI include THERAFECTIN for the treatment of Rheumatoid Arthritis; AF-1 for the potential treatment of stroke and spinal cord injury; 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 and allergies. The foregoing contains certain forward-looking statements with regard to product development timelines and corporate partnering discussions, which may not be realized due to the uncertainties inherent in the research and development and negotiating processes. For further information please contact: Marc E. Lanser, MD Chief Scientific Officer 617-425-0200 5 -----END PRIVACY-ENHANCED MESSAGE-----