<PAGE>
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 21, 2000
-------------------
BOSTON LIFE SCIENCES, INC.
--------------------------
(Exact name of registrant as specified in its charter)
<TABLE>
<S> <C> <C>
Delaware 0-6533 87-0277826
- ------------------------------------------ ------ ------------------------------------
(State or other jurisdiction of (Commission (I.R.S. Employer Identification No.)
incorporation or organization) File No.)
137 Newbury Street
8th Floor
Boston, Massachusetts 02116
- ------------------------------------------ -----------------
(Address of principal executive offices) Zip Code
</TABLE>
Registrant's telephone number, including area code (617) 425-0200
-----------------
<PAGE>
Item 5. Other Events.
-------------
On January 21, 2000, the Company announced that its collaborating scientists had
recently identified a previously unknown biological pathway through which optic
nerve regeneration is apparently stimulated, and that this discovery could
greatly enhance the development of BLSI's proprietary central nervous system
axonal growth factors.
The discovery of this novel pathway (included in the pending patent rights
licensed to the Company through its CNS research program) impacts specifically
on potential ophthalmic applications. Consequently, therapeutic treatment for
glaucoma is now encompassed within the possible uses of AF-1 and Inosine. Both
of these axonal growth factors, which are covered by patents licensed to BLSI,
were previously reported by the Company's collaborating scientists to
significantly stimulate optic nerve regeneration in rats following experimental
injury. However, until now, the exact mechanism by which this occurred was not
known.
The Company also announced that AF-1, which is a naturally occurring proprietary
small molecule, recently demonstrated an ability to stimulate regeneration of
the spinal cord following partial transection in a manner similar to that
achieved by Inosine, another of the Company's CNS small molecule growth factors.
The remarkable spinal cord regenerative effects of Inosine were reported in the
November 9, 1999 issue of the Proceedings of the National Academy of Sciences
(PNAS).
On January 25, 2000, the Company announced that it had completed plans for the
clinical development of Altropane(TM) for the diagnosis of Attention Deficit
Hyperactivity Disorder (ADHD). The Company's plans were finalized following
discussions with the FDA regarding the appropriate structure of the Phase II and
III clinical trials. The Company expects to initiate its Phase II/III program at
the end of the first quarter of 2000. The model for the Phase II/III trials will
be based on the recent study published in The Lancet, which documented the
ability of Altropane to detect a highly statistically significant excess in the
number of dopamine transporters (DATs) in the midbrain of subjects with long-
standing ADHD as compared to normal individuals. The Company believes that the
detection of this physiological abnormality in ADHD individuals will demonstrate
Altropane's effectiveness as a diagnostic imaging agent for ADHD.
The Company also announced that it would submit a Fast Track application for
Altropane in the ADHD indication based on `unmet medical need', since there is
no objective biologic test for ADHD currently available. The Company noted that
its Phase III trials for Altropane as a diagnostic for Parkinson's Disease was
expected to be completed at the end of the first quarter of 2000. Based on the
combined ADHD and Parkinson's Disease patient populations, the Company's
preliminary market projections indicate a combined potential of 300,000 to
500,000 scans per year.
Item 7. Exhibits.
---------
The following Exhibits are filed as part of this report on Form 8-K:
99.1 Press Release, dated January 21, 2000.
99.2 Press Release, dated January 25, 2000.
1
<PAGE>
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: January 28, 2000 By: /s/ Joseph Hernon
-------------------------
Joseph Hernon
Chief Financial Officer
2
<PAGE>
BOSTON LIFE SCIENCES, INC.
CURRENT REPORT ON FORM 8-K
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit No. Pages
----------- -----
<S> <C> <C>
99.1 Press Release, dated January 21, 2000 4 - 5
99.2 Press Release, dated January 25, 2000 6 - 7
</TABLE>
3
<PAGE>
Exhibit 99.1
BOSTON LIFE SCIENCES' CENTRAL NERVOUS SYSTEM PROGRAM IDENTIFIES
OPTIC NERVE REGENERATION PATHWAY
Glaucoma Added to the Company's Spinal Cord Injury and Stroke Drug Development
January 21, 2000--Boston, MA--Boston Life Sciences, Inc. (NASDAQ: BLSI)
announced that the recent identification by the Company's collaborating
scientists of a previously unknown biological pathway through which optic nerve
regeneration is apparently stimulated, will greatly enhance the development of
BLSI's proprietary central nervous system axonal growth factors. These findings
will soon be submitted in an extensive monograph to a premier neurological
journal.
The discovery of this novel pathway (included in the pending patent rights
licensed to BLSI through its CNS research program) impacts specifically on
potential ophthalmic applications. Consequently, therapeutic treatment for
glaucoma is now encompassed within the possible uses of AF-1 and Inosine. Both
of these axonal growth factors (covered by patents licensed to BLSI) were
previously reported by the Company's collaborating scientists to significantly
stimulate optic nerve regeneration in rats following experimental injury.
However, until now, the mechanism by which this occurred was obscure.
Dr. Marc Lanser, Chief Scientific Officer of BLSI, commented, "though we have
understood for some time the mechanism by which Inosine and AF-1 significantly
stimulates nerve regeneration in the corticospinal tract of the spinal cord, the
pathway underlying AF-1's ability to regenerate the optic nerve appeared to be
more complicated. These latest findings on the optic nerve have provided a much
broader platform upon which we expect to expand the development of these
compounds into glaucoma treatment. Glaucoma, which is a major cause of blindness
in the U.S., results from abnormally high intra-ocular pressure which in turn
causes irreversible ischemic destruction of the optic nerve. Present treatment
consists of normalizing intra-ocular pressure but cannot regenerate the
destroyed optic nerve. Noninvasive treatment with AF-1 has the potential to
regrow the optic nerve by stimulating the retinal ganglia cells to regenerate
the axons comprising the optic nerve and thus re-establish their connections in
the visual cortex of the brain, thereby restoring vision."
BLSI also announced that AF-1, which is a naturally occurring proprietary small
molecule, has now been demonstrated to stimulate regeneration of the spinal cord
following partial transection in a manner similar to that achieved by Inosine,
another of the Company's CNS small molecule growth factors. The remarkable
spinal cord regenerative effects of Inosine were reported in the November 9,
1999 issue of the Proceedings of the National Academy of Sciences (PNAS).
"The PNAS article documents the heretofore unprecedented scientific findings
that the long motor tracts of the spinal cord can be regenerated by
administering Inosine directly to the motor cortex of animals," stated Dr.
Lanser. "In a follow-up to the PNAS article, we have recently repeated the
experiments using AF-1 and found the same extraordinary regenerative growth in
the spinal cord. Based on those impressive results, we are aggressively pursuing
pre-clinical development of both AF-1 and Inosine for spinal cord injury and
stroke. We will now add glaucoma."
"In addition to being in the advantageous position of possessing two naturally-
occurring small molecules having potentially extraordinary, broad-based CNS
nerve regenerative properties, our program also has been able to synthesize a
family of small molecule analogues through utilization of our proprietary
knowledge delineating the mechanism by which these molecules work. We believe
that this growing portfolio of CNS growth agents places us within the forefront
of CNS regeneration," added Dr. Lanser.
BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders. In addition to fusion toxins, BLSI's products in
clinical trials or in preclinical development include: Altropane(TM), a
radioimaging agent for the diagnosis of Parkinson's Disease and Attention
Deficit Hyperactivity Disorder; Troponin I, a naturally-occurring anti-
angiogenesis factor for the treatment of solid tumors; AF-1 and Inosine, nerve
growth factors for the treatment of acute and chronic CNS disorders; and
transcription factors that may control the expression of molecules associated
with autoimmune disease and allergies.
4
<PAGE>
Statements made in this press release other than statements of historical fact
represent forward-looking statements. Such statements include, without
limitation, statements regarding expectations or beliefs as to future results or
events, such as the adequacy of the Company's capital resources, discussions
with regulatory agencies, expected timing and results of clinical trials,
schedules of IND, NDA and all other regulatory submissions, the possible
approval of products, the timing of product introductions, the market size for
the Company's products and possible advantages of the Company's products. All
such forward-looking statements involve substantial risks and uncertainties and
actual results may vary materially from these statements. Factors that may
affect future results include: regulatory decisions, results of scientific data
from clinical trials; delays in the regulatory or development processes; the
ability to obtain intellectual property protection, the outcome of discussions
with potential partners, the availability and adequacy of financial resources,
market acceptance of the Company's products and other possible risks and
uncertainties that have been noted in reports filed by the Company with the
Securities and Exchange Commission, including the Company's Annual Report on
Form 10-K/A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
<TABLE>
<CAPTION>
Media Investors Corporate
<S> <C> <C>
Jim Weinrebe Maria Zapf Boston Life Sciences, Inc.
Schwartz Communications Boston Life Sciences, Inc. Marc Lanser, M.D.
781.684.0770 617.425.0200 Chief Scientific Officer
617.425.0200
</TABLE>
5
<PAGE>
Exhibit 99.2
BOSTON LIFE SCIENCES ADVANCES START OF CLINICAL TRIAL FOR
ATTENTION DEFICIT HYPERACTIVITY DISORDER
Clinical development based on recently-reported results published in The Lancet
January 25, 2000--Boston, MA--Boston Life Sciences, Inc. (NASDAQ: BLSI)
announced that the Company has completed its plans for the clinical development
of Altropane(TM) for the diagnosis of Attention Deficit Hyperactivity Disorder
(ADHD). The Company expects to initiate its Phase II/III program at the end of
the first quarter of 2000. The Company's plans were finalized after discussing
with the FDA the appropriate structure for the Phase II and III clinical trials.
The structure of these trials is based on the data recently published in the
medical journal The Lancet. The Lancet article documented the ability of
Altropane to detect a highly statistically significant excess in the number of
dopamine transporters (DATs) in the midbrain of subjects with long-standing ADHD
compared to normal individuals. The Company believes that the detection of this
physiological abnormality in ADHD individuals will demonstrate Altropane's
effectiveness as a diagnostic imaging agent for ADHD.
"We will be submitting a Fast Track application for Altropane in the ADHD
indication based on `unmet medical need', since there is presently no objective
biologic test for ADHD available," stated Marc Lanser, MD, and Chief Scientific
Officer of BLSI.
"Based on the compelling human data recently published in The Lancet by Dr. Alan
Fischman, Chief of Nuclear Medicine at the Massachusetts General Hospital, we
plan to perform a 40 subject Phase II trial in order to expand the database on
normal individuals and to elaborate on the findings of The Lancet study. We will
then proceed with two parallel Phase III studies in adults 20 - 40 years of age.
Upon obtaining successful results of these trials, we will then file for
marketing approval for Altropane to diagnose ADHD in adults. Upon completion of
these parallel adult trials, in line with guidance from the FDA, we will
initiate a comprehensive Phase III study in children in order to expand the
indication for this diagnostic to serve the millions of schoolchildren for whom
the diagnosis of ADHD is often a perplexing issue for doctors, educators and
parents. The same diagnostic agent, Altropane, is currently completing a Phase
III trial for the diagnosis of Parkinson's Disease. Approximately 85% of patient
enrollment is completed. We expect to finish that study at the end of the first
quarter of this year, and to file for marketing approval for the Parkinson's
Disease indication as soon as possible thereafter," added Dr. Lanser.
"We are extremely excited by the total market prospects for Altropane in both PD
and ADHD," commented David Hillson, the Company's President and Chief Executive
Officer. "It is estimated that 250,000 individuals per year present to their
physician with new, undiagnosed movement disorders, and are therefore candidates
for an Altropane scan to diagnose or rule-out early Parkinson's Disease. In the
far larger ADHD market, a conservatively estimated 1.5 million adults between
the ages of 20 to 40 are tentatively diagnosed with ADHD. The most significant
single market is, of course, the 5 million children who are categorized as ADHD.
The annual incidence (new cases) is about 500,000. We believe that an effective
diagnostic for ADHD will provide a much-needed objective basis for therapeutic
intervention with drugs such as Ritalin(R). Totaling the use of Altropane for
both PD and ADHD indications, this imaging agent has the potential, if approved,
to become one of the largest selling radiopharmaceuticals ever developed. Our
preliminary projections point toward a combined potential of 300,000 to 500,000
scans per year."
BLSI is developing novel diagnostics for Parkinson's Disease and ADHD as well as
treatments for cancer, autoimmune diseases, and central nervous system
disorders. In addition to Altropane, BLSI's products in preclinical development
include: Troponin I, a naturally-occurring anti-angiogenesis factor for the
treatment of solid tumors; AF-1 and Inosine, nerve growth factors for the
treatment of acute and chronic CNS disorders; fusion toxins for the treatment of
cancer and multiple sclerosis; and transcription factors that may control the
expression of molecules associated with autoimmune disease and allergies.
6
<PAGE>
Statements made in this press release other than statements of historical fact
represent forward-looking statements. Such statements include, without
limitation, statements regarding expectations or beliefs as to future results or
events, such as expected timing and results of clinical trials, discussions with
regulatory agencies, schedules of IND, NDA and all other regulatory submissions,
the timing of product introductions, the possible approval of products, the
market size for the Company's products and possible advantages of the Company's
products. All such forward-looking statements involve substantial risks and
uncertainties and actual results may vary materially from these statements.
Factors that may affect future results include: regulatory decisions, results of
scientific data from clinical trials; delays in the regulatory or development
processes; the ability to obtain intellectual property protection, the outcome
of discussions with potential partners, the availability and adequacy of
financial resources, market acceptance of the Company's products and other
possible risks and uncertainties that have been noted in reports filed by the
Company with the Securities and Exchange Commission, including the Company's
Annual Report on Form 10-K/A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
<TABLE>
<CAPTION>
Media Investors Corporate
<S> <C> <C>
Jim Weinrebe Maria Zapf Boston Life Sciences, Inc.
Schwartz Communications Boston Life Sciences, Inc. Marc Lanser, MD
781.684.0770 617.425.0200 Chief Scientific Officer
www.bostonlifesciences.com 617.425.0200
</TABLE>
7
