-----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, Dy5FTirMLCXVzwQuixGMtWUSArsjVsinB7yf8BBXqB/3+Qkv3oVFxTuhjd3GwxNQ Y7qAWkCPBM2aM97kJyBrxg== 0001036050-97-000822.txt : 19971014 0001036050-97-000822.hdr.sgml : 19971014 ACCESSION NUMBER: 0001036050-97-000822 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19970930 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19971010 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: 97693495 BUSINESS ADDRESS: STREET 1: 31 NEWBURY ST STREET 2: SUITE 300 CITY: BOSTON STATE: MA ZIP: 02116 BUSINESS PHONE: 6178908263 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) September 30, 1997 ---------------------- 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. ------------ 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 (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 variables were the number of painful joints, the number of swollen joints, the patient's global assessment, and the physician's global assessment. The results were analyzed on an Intent to Treat (ITT), Last Observation Brought Forward (LOBF) basis. The Company reported that preliminary analysis of the results did not demonstrate a statistically significant difference between Therafectin and placebo in the percentage of patients achieving "Therapeutic Success". 40% of patients receiving Therafectin and 33% of patients receiving placebo achieved "Therapeutic Success". The Company also noted that in centers that enrolled at least 10 patients, 48% of Therafectin patients achieved "Therapeutic Success" as compared to placebo patients who achieved "Therapeutic Success" in 29% of cases. Among 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. 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. While Therafectin performed better than placebo, the Company expressed its disappointment that the primary endpoint fell short of statistical significance. The Company will seek input and advice from an advisory panel of rheumatologists to help determine whether to proceed with a submission of an amendment to the pending NDA seeking approval for the drug. The focus of the Company will remain on the development of all of the products in its portfolio, including Altropane, a Parkinson's Disease diagnostic imaging agent projected to complete clinical trials in the first half of 1998; Troponin, its anti-angiogenic agent for which an IND filing is planned for the first half of 1998; Axogenesis Factor 1, a Central Nervous System growth factor; and C-maf a novel T-cell switch factor. The Company believes its current cash is adequate to sustain its R&D programs through 1999. Item 7. Exhibits. -------- The following Exhibits are filed as part of this report on Form 8-K: 99.1 Press Release, dated September 30, 1997. 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: October 9, 1997 By:/s/ Joseph Hernon ------------------ Joseph Hernon Chief Financial Officer BOSTON LIFE SCIENCES, INC. CURRENT REPORT ON FORM 8-K EXHIBIT INDEX Exhibit No. Page - ----------- ---- 99.1 Press Release, dated September 30, 1997 5 EX-99.1 2 PRESS RELEASE Exhibit 99.1 FOR IMMEDIATE RELEASE BOSTON LIFE SCIENCES ANNOUNCES RESULTS OF ITS PHASE III TRIAL FOR THERAFECTIN(R) September 30, 1997--Boston, MA--Boston Life Sciences, Inc. (NASDAQ: BLSI) announced the results of its double-blind, placebo-controlled Phase III trial of Therafectin(R) for the treatment of Rheumatoid Arthritis (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), Last Observation Brought Forward (LOBF) basis. Preliminary analysis of the results did not demonstrate a statistically significant difference between Therafectin and placebo in the percentage of patients achieving "Therapeutic Success", the Company said. 40% of patients receiving Therafectin and 33% of patients receiving placebo achieved "Therapeutic Success". The Company also noted that in centers that enrolled at least ten patients, 48% of Therafectin patients achieved "Therapeutic Success" as compared to placebo patients who achieved "Therapeutic Success" in 29% 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 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 diagnostic imaging agent which is projected to complete clinical trials in the first half of 1998; Troponin, 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, and central nervous system disorders. In addition to THERAFECTIN, BLSI's products in clinical trials or in preclinical development include Troponin I, 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 and allergies. For additional information contact: Marc E. Lanser, MD or S. David Hillson Chief Scientific Officer President and CEO 617-425-0200 ### -----END PRIVACY-ENHANCED MESSAGE-----