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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
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BOSTON LIFE SCIENCES, INC.
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(Exact name of registrant as specified in its charter)
Delaware 0-6533 87-0277826
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(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
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(Address of principal executive offices) Zip Code
Registrant's telephone number, including area code (617) 425-0200
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Item 5. Other Events.
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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.
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The following Exhibits are filed as part of this report on Form 8-K:
99.1 Press Release, dated September 30, 1997.
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SIGNATURES
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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
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Joseph Hernon
Chief Financial Officer
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BOSTON LIFE SCIENCES, INC.
CURRENT REPORT ON FORM 8-K
EXHIBIT INDEX
Exhibit No. Page
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99.1 Press Release, dated September 30, 1997 5
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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
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