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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) January 20, 1998
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BOSTON LIFE SCIENCES, INC.
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(Exact name of registrant as specified in its charter)
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<CAPTION>
<S> <C> <C>
Delaware 0-6533 87-0277826
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(State or other jurisdiction of (Commission (I.R.S. Employer Identification No.)
incorporation or organization) File No.)
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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 that based on further extensive analysis of
data from the Company's recently completed Phase III trial of Therafectin and
the input obtained from its special panel of clinical rheumatologists, the
Company intends to file an amendment to its current NDA seeking marketing
approval for Therafectin.
A number of important findings in the analysis of the data strongly suggest
therapeutic efficacy. The findings include the following: Applying the widely-
accepted "Paulus" criteria of therapeutic efficacy, there was a highly
statistically significant difference in the percentage of Therafectin patients
meeting the Paulus criteria for therpeutic efficacy as compared to the
percentage of placebo patients meeting the Paulus criteria (p less than 0.02).
Among the predefined secondary efficacy variables, the reduction in the number
of swollen joints, the ESR results, Functional Class scores, and the CLINHAQ (a
quality of life measurement) were all statistically significant in favor of
Therafectin. In addition, after withdrawing non-steroidal medication, all
clinical secondary variables returned to baseline or better in the Therafectin
group, while in the placebo group, these clinical variables remained
statistically significantly worse than baseline. Applying the American College
of Rheumatology (ACR) "50% improvement" criteria to the number of swollen
joints, 36% of Therafectin patients experienced at least 50% decrease in the
number of swollen joints, compared to 23% of placebo patients, a statistically
significant difference (p less than 0.04). Finally, in the subgroup of patients
(about half the total number) entering the study with greater than the median
number of swollen joints (ten), all the primary variables as specified in the
trial protocol were statistically significant, as were the secondary variables.
The Company's decision to file for marketing approval reflects the advice that
it received from an ad hoc panel of clinical rheumatologists that was convened
to evaluate the cumulative data on Therafectin and to assess the potential
clinical utility of the drug. The consensus of the panel was that the
cumulative safety and efficacy data on Therafectin justified its use by
clinicians looking for a safe alternative to other more toxic drugs that are
used to treat Rheumatoid Arthritis.
BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders.
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 January 20, 1998.
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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: January 27, 1998 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(s)
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99.1 Press Release, dated January 20, 1998 6-7
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Exhibit 99.1
FOR IMMEDIATE RELEASE
BOSTON LIFE SCIENCES ANNOUNCES RESULTS OF ITS EXTENSIVE ANALYSIS OF PHASE III
THERAFECTIN DATA
Boston MA, January 20, 1998. Boston Life Sciences, Inc. (NASDAQ: BLSI)
announced today that, based upon further extensive analysis of data from the
Company's recently completed Phase III Rheumatoid Arthritis trial of Therafectin
and the input obtained from its special panel of clinical rheumatologists, that
the Company intends to seek marketing approval for Therafectin.
"We are very gratified that a significant number of important findings in the
analysis of the data as embodied in the medical report of the trial strongly
suggest therapeutic efficacy", stated Marc Lanser, MD, Chief Scientific Officer
of BLSI. "These findings include the following: Applying the widely-accepted
"Paulus" criteria of therapeutic efficacy (at least a 20% improvement in 4 of 6
measures: joint tenderness scores, joint swelling scores, physician's and
patient's global assessment, erythrocyte sedimentation rate (ESR), and morning
stiffness), there was a highly statistically significant difference in the
percentage of Therafectin patients meeting the Paulus criteria for therapeutic
efficacy as compared to the percentage of placebo patients meeting the Paulus
criteria (p less than 0.02). Among the predefined secondary efficacy variables,
the reduction in the number of swollen joints, the ESR results, Functional Class
scores, and the CLINHAQ (a quality of life measurement) were all statistically
significant in favor of Therafectin. In addition, after withdrawing non-
steroidal medication, all clinical secondary variables returned to baseline or
better in the Therafectin group, while in the placebo group, these clinical
variables remained statistically significantly worse than baseline. Applying the
American College of Rheumatology (ACR) "50% improvement" criteria to the number
of swollen joints, 36% of Therafectin patients experienced at least a 50%
decrease in the number of swollen joints, compared to 23% of placebo patients, a
statistically significant difference (p less than 0.04). Finally, in the
subgroup of patients (about half the total number) entering the study with
greater than the median number of swollen joints (ten), all the primary
variables as specified in the trial protocol were statistically significant, as
were the secondary variables."
"In our opinion, statistically significant improvement in the important clinical
variables related to joint swelling, functional class, and "quality of life"
experienced by the Therafectin patients demonstrates the clinical efficacy of
Therafectin. Because the beneficial effect is most obvious on joint swelling,
we believe that the other improvements are secondary to Therafectin's apparent
ability to favorably impact the underlying disease. We are not surprised that
patients with more active disease received the greatest overall benefit from the
drug, since patients with mild disease have "less room" to improve; therefore
any drug effect would be more difficult to demonstrate in mild disease," added
Dr. Lanser.
"Our intention to seek marketing approval grows out of the advice we received
from an ad hoc panel of clinical rheumatologists that was convened to evaluate
the cumulative data on Therafectin and to assess the potential clinical utility
of the drug. The consensus of the panel was that the cumulative safety and
efficacy data on Therafectin justified its use by clinicians looking for a safe
alternative to the other more toxic drugs now being used to treat Rheumatoid
Arthritis", stated David Hillson, President and CEO of BLSI. "Based on the
favorable data emanating from the trial and the consensus of the Panel, we are
looking forward to further early interaction with the FDA following completion
of our new data package," added Mr. Hillson.
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BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders. In addition to Therafectin, products in clinical
trials or in preclinical development by BLSI and its collaborating scientists
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 the prospects
for Therafectin and the timing of regulatory filings. Actual results may vary
materially, and there can be no assurance that regulatory approval will be
obtained. Among the meaningful factors that could affect the results obtained
are the difficulties in preparing for or attaining necessary regulatory
approvals and other matters.
For additional information contact:
Marc E. Lanser, MD
Chief Scientific Officer
617-425-0200
