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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) November 3, 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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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.)
31 Newbury Street, Suite 300
Boston, Massachusetts 02116
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(Address of principal executive offices) Zip Code
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Registrant's telephone number, including area code (617) 425-0200
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Item 5. Other Events.
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On November 3, 1998, Boston Life Sciences, Inc. announced that the Company had
received a Notice of Issuance of its patent on the use of Troponin I to treat
angiogenic diseases. The patent, assigned USP# 5,837,680 is due to issue on
November 17, 1998. The Company believes that the issued claims are extremely
extensive and cover the use of Troponin to treat solid tumors, eye diseases,
atherosclerosis, hypertrophic scarring (including in the spinal cord),
arthritis, and psoriasis, among others. The Company expects that the issuance
of this patent will serve to further increase the interest of potential
corporate partners since ultimate patent protection is always a concern of
potential pharmaceutical partners.
On November 10, 1998, Boston Life Sciences, Inc. announced that its
collaborating scientists had presented new findings regarding the regulation of
axon growth in CNS nerve cells. These findings were presented on November 8,
1998 at the annual meeting of the Society for Neuroscience by Dr. Larry Benowitz
and colleagues from the Children's Hospital and Harvard Medical School in
Boston, and have just been published in The Journal of Biological Chemistry. The
Company regards these findings as extremely important since they describe the
intracellular pathway that may control axon growth in all nerve cells. The
Company believes that its compound may have the unique ability to regenerate
axons in the functionally important pyramidal tracts that descend along the
entire length of the spinal cord. However, the Company cautioned that only
clinical trials can determine whether these preliminary anatomic results will
translate into functional recovery in humans.
On November 12, 1998, Boston Life Sciences, Inc. reported that results of its
Phase III trial of its Rheumatoid Arthritis (RA) drug, Therafectin, were
presented at the annual meeting of the American College of Rheumatology in San
Diego, California on November 10, 1998. Highlighted in the ACR presentation were
the statistically significant differences in favor of THERAFECTIN observed in
the Paulus Criteria, the number of patients experiencing at least a 50%
reduction in swollen joints, duration of morning stiffness, erythrocyte
sedimentation rate, and the Clinical Health Assessment Questionnaire (CLINHAQ).
The Company believes that if approved, Therafectin's outstanding safety profile
established in clinical trials and off-protocol use by RA patients should
enhance its appeal as a first line therapy. The Company also noted that at a
projected annual cost of $1,200 per patient, Therafectin could occupy a useful
position in the broad RA market. The Company cautioned that there can be no
assurance that such approval will be forthcoming.
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 November 3, 1998.
99.2 Press Release, dated November 10, 1998.
99.3 Press Release, dated November 12, 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: November 12, 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
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Exhibit No. Page(s)
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99.1 Press Release, dated November 3, 1998 4
99.2 Press Release, dated November 10, 1998 5
99.3 Press Release, dated November 12, 1998 6
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Exhibit 99.1
FOR IMMEDIATE RELEASE
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BOSTON LIFE SCIENCES COMMENTS ON ISSUANCE AND SIGNIFICANCE OF ANTI-ANGIOGENESIS
PATENT COVERING MAJOR DISEASES
November 3, 1998, Boston, MA- Boston Life Sciences, Inc. (NASDAQ: BLSI)
announced that the Company had received Notice of Issuance of its patent on the
use of Troponin I to treat a broad spectrum of angiogenic diseases. The patent
was assigned USP# 5,837,680 and is due to issue November 17, 1998, the Company
said.
"The issued claims are extremely extensive; covering the use of Troponin to
treat solid tumors, eye diseases, atherosclerosis, hypertrophic scarring
(including in the spinal cord), arthritis, and psoriasis, among others," stated
Dr. Marc Lanser, Chief Scientific Officer of BLSI. "Evidence is accumulating at
a rapid pace indicating that in addition to metastatic growth, anti-angiogenesis
may play an important role in treatment strategies to address coronary
atherosclerosis and spinal cord injury. With this patent, and our latest
results from our recent, extensive pre-clinical metastases studies, our stake in
the anti-angiogenesis sector continues to grow more and more meaningful," added
Dr. Lanser.
David Hillson, President and CEO added: "Troponin has interested a number of
potential corporate partners based upon both the efficacy results in inhibiting
tumor metastases as well as retinal neovascularization. We believe that BLSI
programs to extend Troponin into the areas of heart disease and spinal injury
represent huge additional opportunities. We expect that the issuance of the
patent will serve to further increase that interest, since ultimate patent
protection is always a concern of potential pharmaceutical partners."
BLSI is developing novel treatments for cancer, autoimmune disease, and central
nervous system disorders. In addition to Troponin I, 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; 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 further information please contact:
Marc E. Lanser, MD
Chief Scientific Officer
617-425-0200
4
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Exhibit 99.2
FOR IMMEDIATE RELEASE
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BOSTON LIFE SCIENCES' COLLABORATING SCIENTISTS ELUCIDATE THE
MECHANISM UNDERLYING AXON REGENERATION IN THE CENTRAL NERVOUS
SYSTEM (CNS)
NOVEMBER 10, 1998--BOSTON, MA. BOSTON LIFE SCIENCES, INC. (NASDAQ: BLSI)
announced that its collaborating scientists have presented new findings
concerning the regulation of axon growth in CNS nerve cells. These findings
were presented on November 8, 1998, at the annual meeting of the Society for
Neuroscience by Dr. Larry Benowitz and colleagues from the Children's Hospital
and Harvard Medical School in Boston. The findings have additionally just been
published in The Journal of Biological Chemistry, vol. 273; pp. 29626-29634;
1998, the Company said.
"We regard these findings as extremely important, since they describe for the
first time the intracellular pathway that may control axon growth in all nerve
cells. We believe BLSI has established a very promising proprietary position
regarding therapeutic intervention in this pathway; one that includes our two
lead nerve regeneration compounds," stated Dr. Marc Lanser, Chief Scientific
Officer at BLSI. "Subsequent research by our collaborating scientists in
animals using one of BLSI's licensed compounds has not only reinforced the
potential importance of this pathway in regenerating nerve cell axons, but also
indicates that our compound has the apparent unique ability to regenerate axons
in the functionally important pyramidal tracts that descend along the entire
length of the spinal cord. Upon further confirmation of these preliminary
anatomic findings, it would be, to our knowledge, the first time that any
compound has been shown to substantially regenerate axons in the pyramidal
tract, which is absolutely vital for achievement of functional recovery in
humans," added Dr. Lanser.
Given the importance of pyramidal tract regeneration, we believe that these
results obtained in a highly recognized model demonstrate BLSI's leading role in
the field of CNS nerve regeneration. However, only clinical trials can
determine whether these preliminary anatomic results will translate into
functional recovery in humans," stated David Hillson, President of BLSI. "This
success has strengthened our commitment to the development of these compounds
for spinal cord injury, stroke, and eventually chronic CNS degenerative diseases
as well," added Mr. Hillson.
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; Altropane, a radioimaging agent for the diagnosis of
Parkinson's Disease; AF1 and others for the potential treatment of stroke and
spinal cord injury; 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, which may not be realized due to the uncertainties inherent in the
research and development process, including applying laboratory results to the
design and completion of clinical trials.
For further information please contact:
Marc E. Lanser, MD
Chief Scientific Officer
617-425-0200
5
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Exhibit 99.3
FOR IMMEDIATE RELEASE
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RESULTS OF BOSTON LIFE SCIENCES' PHASE III THERAFECTIN STUDY PRESENTED AT
AMERICAN COLLEGE OF RHEUMATOLOGY MEETING
November 12, 1998--Boston, MA. Boston Life Sciences, Inc. (NASDAQ: BLSI)
announced that results of its Phase III trial of its Rheumatoid Arthritis drug
THERAFECTIN were presented at the annual meeting of the American College of
Rheumatology (ACR) in San Diego, California on November 10, 1998. The
presentation, entitled "Amiprilose Hydrochloride (THERAFECTIN) for the Treatment
of Rheumatoid Arthritis" was made by Dr. David Trentham, Chief of Rheumatology,
Beth Israel Deaconess Hospital, and Associate Professor of Medicine, Harvard
Medical School, Boston, MA.
Highlighted in the ACR presentation were the statistically significant
differences in favor of THERAFECTIN observed in the Paulus Criteria, the number
of patients experiencing at least a 50% reduction in swollen joints, duration of
morning stiffness, erythrocyte sedimentation rate, and the Clinical Health
Assessment Questionnaire (CLINHAQ). The abstract of the presentation concluded:
"This study provides an independent confirmation that the novel and nontoxic
carbohydrate, amiprilose HCl, provides an effective approach to the treatment of
RA."
"If THERAFECTIN is approved, we believe that its outstanding safety profile
established in four clinical trials as well as several years of off-protocol use
by RA patients should enhance its appeal as a first line therapy, though there
can be no assurances that such approval will be forthcoming. We also note that
at a projected annual cost of $1,200 per patient per year, THERAFECTIN could
occupy a useful position in the broad RA market. We expect to complete initial
arrangements for commercial tablet manufacturing and packaging in the next
several weeks," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI.
The double-blind, randomized multi-center Phase III trial was completed
approximately one year ago, and an amendment to the outstanding NDA containing
the study results was submitted to the FDA on June 30, 1998. A summary of the
results of this trial was reported in a company press release dated January 20,
1998.
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; Altropane, a radioimaging agent for the diagnosis of
Parkinson's Disease; AF1 and others for the potential treatment of stroke and
spinal cord injury; 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, regulatory filings and approvals, and commercial
manufacturing and market projections, which may not be realized due to the
uncertainties inherent in product development and regulatory processes.
For further information please contact:
Marc E. Lanser, MD
Chief Scientific Officer
617-425-0200
6
