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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) December 13, 1999
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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>
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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.)
137 Newbury Street
8th Floor
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 December 13, 1999, the Company announced that its collaborating researchers
at Beth Israel Deaconess Medical Center and Harvard Medical School had
identified and described one of the possible mechanisms by which BLSI's
anti-angiogenic Troponin I inhibits angiogenesis. Laurie Feldman, Ph.D.,
presented the results of the study at the national meeting of the American
Society of Hematology, held in New Orleans, December 3-7, 1999.
The results of the study, entitled Troponin I inhibits endothelial cell
proliferation by interaction with the cell's bFGF receptor, indicated that the
anti-angiogenic properties of Troponin I may be explained by the direct
interaction (and inhibition) of Troponin I with the bFGF receptor on endothelial
cells. Direct interaction of Troponin I with the bFGF receptor results in the
cell's unresponsiveness to basic Fibroblast Growth Factor (bFGF). Because bFGF
is one of the major pro-angiogenic stimuli produced by tumors, this mechanism
may be responsible for the potent in vivo anti-angiogenic and anti-metastatic
effects of Troponin I. Since VEGF (another important pro-angiogenic stimulus)
stimulation of endothelial cell proliferation is similarly inhibited by Troponin
I, it appears likely that Troponin I inhibits both these factors by similar
mechanisms; i.e., by direct inhibition of their respective receptors.
The Company noted that it hopes to initiate a Phase I/II human study in sarcomas
and prostate cancer patients at the Dana Farber Cancer Institute in Boston
during the first half of 2000.
On December 17, 1999, the Company released details of a human clinical study
demonstrating that its diagnostic radioimaging agent, Altropane(TM), had
detected an abnormal elevation in the number of dopamine transporters (DATs) in
the brains of subjects with longstanding Attention Deficit Hyperactivity
Disorder (ADHD). The study appeared in the December 18, 1999 issue of the
journal The Lancet.
The Company believes that this was the first clinical study to demonstrate that
there is a measurable biochemical abnormality in patients with ADHD. In this
trial, adult patients with expertly-diagnosed, longstanding ADHD underwent
Altropane-SPECT brain scans, and a Striatal Binding Potential (SBP) was
calculated for each patient. The SBP is an indirect measure of the quantity of
dopamine transporters (DATs) in the brain. Each and every ADHD patient had a SBP
that was at least two standard deviations above the mean SBP of age-matched
controls. These results demonstrated that abnormal levels of the DAT were
directly associated with the clinical symptoms of ADHD in this patient group.
Altropane is a small molecule invented by researchers at Harvard and the
Massachusetts General Hospital that binds with extremely high affinity and
specificity to the DAT. Consequently, the amount of Altropane taken up by the
brain is directly proportional to the number of DATs that are present in any
given area of the brain. In Parkinson's Disease (PD), there is a marked decrease
in the number of DATs in the striatal region of the brain. As a result,
Altropane uptake is substantially diminished. This marked decrease in Altropane
uptake in PD is the basis for BLSI's diagnostic test for early PD. For this
application, Altropane is now in a Phase III trial and if successfully
completed, will be submitted for marketing approval next year. Conversely, as
now suggested by The Lancet study, ADHD appears to be associated with an excess
number of DATs in this same region and thus Altropane has the potential to prove
to be a powerful diagnostic for ADHD as well.
ADHD is the most commonly diagnosed behavioral disorder in children and is the
fastest growing psychiatric disorder in adults. Since 1990, the total number of
American children diagnosed with ADHD has risen from 900,000 to over 5.5
million, and the use of stimulant medication such as Ritalin(R) has increased
700% in the same period. ADHD is currently diagnosed according to a set of
behavioral criteria defined in the Diagnostic and Statistical Manual (DSM) used
by psychiatrists. However, it has not been possible to validate these criteria
against an objective biological standard, since such a standard has never been
established and does not currently exist.
The Company hopes to initiate Phase II/III testing for the diagnosis of ADHD
early in 2000. The clinical protocol for the ADHD study is currently under
review by radioimaging and ADHD experts at the Massachusetts General Hospital
and Children's Hospital at the University of Pennsylvania.
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 December 13, 1999.
99.2 Press Release, dated December 17, 1999.
1
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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: December 20, 1999 By: /s/Joseph Hernon
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Joseph Hernon
Chief Financial Officer
2
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BOSTON LIFE SCIENCES, INC.
CURRENT REPORT ON FORM 8-K
EXHIBIT INDEX
Exhibit No. Pages
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99.1 Press Release, dated December 13, 1999 4
99.2 Press Release, dated December 17, 1999 5 - 6
3
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Exhibit 99.1
FOR IMMEDIATE RELEASE
MECHANISM OF BLOOD VESSEL INHIBITION OF TROPONIN I, BOSTON LIFE SCIENCES' ANTI-
ANGIOGENIC, PRESENTED AT AMERICAN SOCIETY OF HEMATOLOGY MEETING
December 13, 1999--Boston, MA--Boston Life Sciences, Inc. (NASDAQ: BLSI)
announced that its collaborating researchers at Beth Israel Deaconess Medical
Center and Harvard Medical School have identified and described one of the
possible mechanisms by which BLSI's anti-angiogenic Troponin I inhibits
angiogenesis. The results of the study were presented by Laurie Feldman, Ph.D.,
at the recent national meeting of the American Society of Hematology, held in
New Orleans, December 3-7, 1999.
The results of the study, entitled Troponin I inhibits endothelial cell
proliferation by interaction with the cell's bFGF receptor, indicate that the
anti-angiogenic properties of Troponin I may be explained by the direct
interaction (and inhibition) by Troponin I with the bFGF receptor on endothelial
cells. Direct interaction of Troponin I with the bFGF receptor results in the
cell's unresponsiveness to basic Fibroblast Growth Factor (bFGF). Since bFGF is
one of the major pro-angiogenic stimuli produced by tumors, this mechanism may
be responsible for the potent in vivo anti-angiogenic and anti-metastatic
effects of Troponin I. Since VEGF (another important pro-angiogenic stimulus)
stimulation of endothelial cell proliferation is similarly inhibited by Troponin
I, it appears likely that Troponin I inhibits both these factors by similar
mechanisms; i.e., by direct inhibition of their respective receptors.
"The fact that Troponin I has now been shown to work by direct inhibition of the
bFGF receptor, and the prospect that Troponin I inhibits VEGF by a similar
mechanism makes Troponin I somewhat unique in this regard," stated Marc E.
Lanser, MD, Chief Scientific Officer of BLSI. "To our knowledge, no other
anti-angiogenic factor has been shown to work by direct inhibition of both the
bFGF and VEGF receptors. This mechanism, if confirmed through further
experimentation, could have significant potential advantages, since it would
allow for inhibition of the two most important pro-angiogenic stimuli without
having to administer a mixture of antibodies or small molecules against
intracellular targets.
Dr. Lanser noted that the Company expects to initiate a Phase I/II human study
in sarcomas and prostate cancer patients at the Dana Farber Cancer Institute in
Boston during the first half of 2000.
BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders. In addition to Troponin I, BLSI's products awaiting
FDA review, in clinical trials or in preclinical development include:
Altropane(TM), a radioimaging agent for the diagnosis of Attention Deficit
Disorder and Parkinson's Disease; AF-1 and Inosine, nerve growth factors for the
treatment of stroke and spinal cord injury and Therafectin(R), an oral drug for
the treatment of Rheumatoid Arthritis.
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 expected timing and results of clinical trials, schedules of
IND, NDA, and other regulatory submissions, 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: results of
scientific data from clinical trials; delays in the regulatory or development
processes; the ability to obtain intellectual property protection, the
availability of financing, 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 additional information, please contact:
Corporate Investor Media
Marc Lanser, M.D. Maria Zapf Jim Weinrebe
Chief Scientific Officer Investor Relations Schwartz Communications
617.425.0200 617.425.0200 781.684.0770
<PAGE>
Exhibit 99.2
THE LANCET PUBLISHES CLINICAL RESULTS OF BOSTON LIFE SCIENCES'
ALTROPANE(TM) FOR USE IN THE DIAGNOSIS OF
ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
December 17, 1999--Boston, MA--Boston Life Sciences, Inc. (NASDAQ:BLSI) released
details of a human clinical study demonstrating that its diagnostic radioimaging
agent, Altropane(TM), has detected an abnormal elevation in the number of
dopamine transporters (DATs) in the brains of subjects with longstanding
Attention Deficit Hyperactivity Disorder (ADHD). The study appears in the
current issue of the prestigious British medical journal The Lancet.
Dr. Alan Fischman, senior author of The Lancet study, and Chief of Nuclear
Medicine at the Massachusetts General Hospital stated, "the findings in this
study are very significant, and demonstrate that Altropane potentially could be
of great value in establishing the existence of an objective biological
abnormality in ADHD."
Upon reviewing the study, psychiatrist Edward Hallowell, M.D, nationally
recognized expert in ADHD and author of the book Driven to Distraction, stated,
"Altropane is the most promising development I've seen in a long time in terms
of our coming up with an actual physical test that could help us pin down the
diagnosis of ADHD."
"There is currently great concern among parents, educators and health
professionals regarding the accuracy of current psychosocial criteria used to
diagnose ADHD, particularly in children, and the related problem of
inappropriate use of potentially addictive stimulant medication for this
poorly-defined condition. If the positive results obtained in our initial study
in adults are further confirmed in children, we expect that Altropane will prove
to be of immense value in helping health professionals and parents to deal with
these important issues. Given its potential use to objectively diagnose ADHD in
students as well as young adults who exhibit symptoms of inattentiveness and
hyperactivity, Altropane can also provide a definitive basis for the use of
medication in those patients who might otherwise be reluctant to initiate drug
therapy," stated Marc Lanser, MD, Chief Scientific Officer of BLSI.
John Heavener, Chief Executive Officer of CHADD, the nation's leading advocacy
organization dealing with ADHD stated, "Altropane is potentially a valuable tool
in reinforcing the diagnosis of the ADHD, and in providing the public with proof
the disorder exists. We receive 200 to 300 calls everyday asking about the
diagnosis and treatment of ADHD and we are encouraged that Altropane may be a
meaningful tool in advancing the science used to diagnose the disorder."
"To our knowledge, this is the first clinical study to demonstrate that there is
a measurable biochemical abnormality in patients with ADHD. In this trial, adult
patients with expertly-diagnosed, longstanding ADHD underwent Altropane-SPECT
brain scans. In the scan, a Striatal Binding Potential (SBP) was calculated for
each patient. The SBP is an indirect measure of the quantity of dopamine
transporters (DATs) in the brain. Each and every ADHD patient had a SBP that was
at least two standard deviations above the mean SBP of age-matched controls.
These results demonstrated that abnormal levels of the DAT are directly
associated with the clinical symptoms of ADHD in this patient group," added Dr.
Lanser.
Altropane is a small molecule invented by researchers at Harvard and the
Massachusetts General Hospital that binds with extremely high affinity and
specificity to the DAT. Consequently, the amount of Altropane taken up by the
brain is directly proportional to the number of DATs that are present in any
given area of the brain. In Parkinson's Disease (PD), there is a marked decrease
in the number of DATs in the striatal region of the brain. As a result,
Altropane uptake is substantially diminished. This marked decrease in Altropane
uptake in PD is the basis for BLSI's diagnostic test for early PD. For this
application, Altropane is now in a Phase III trial and if successfully
completed, will be submitted for marketing approval next year. Conversely, as
now suggested by The Lancet study, ADHD appears to be associated with an excess
number of DATs in this same region and thus Altropane has the potential to prove
to be a powerful diagnostic for ADHD as well.
<PAGE>
ADHD is the most commonly diagnosed behavioral disorder in children and is the
fastest growing psychiatric disorder in adults. Since 1990, the total number of
American children diagnosed with ADHD has risen from 900,000 to over 5.5
million, and the use of stimulant medication such as Ritalin(R) has increased
700% in the same period. ADHD is currently diagnosed according to a set of
behavioral criteria defined in the Diagnostic and Statistical Manual (DSM) used
by psychiatrists. However, it has not been possible to validate these criteria
against an objective biological standard, since such a standard has never been
established and does not currently exist. Consequently, the DSM criteria have
generated widespread concern and, in the view of many critics, often are
misapplied and misinterpreted. The lack of a clear-cut, demonstrated biological
basis for ADHD has led to a great deal of confusion concerning the diagnosis of
ADHD and has even provoked skepticism regarding the very existence of the
disorder.
"With 5-10% of approximately 55 million school-age children currently diagnosed
with some form of ADHD, roughly 1.5 million initial visits for ADHD per year,
and with approximately 1.5 million adults diagnosed with ADHD, the Company
believes that Altropane has the potential, if approved, to become one of the
largest selling radio-pharmaceutical diagnostics ever developed. We hope to
initiate Phase II/III testing for the diagnosis of ADHD early in 2000. The
clinical protocol for the ADHD study is currently under review by radioimaging
and ADHD experts at the Massachusetts General Hospital and Children's Hospital
at the University of Pennsylvania," stated David Hillson, CEO of BLSI.
BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders. In addition to Altropane(TM), which is presently in
Phase III testing for the diagnosis of Parkinson's Disease, BLSI's products
awaiting FDA review, in clinical trials or 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; transcription factors that may control the expression
of molecules associated with autoimmune disease and allergies; and
Therafectin(R), an oral drug for the treatment of Rheumatoid Arthritis.
###
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 expected timing and results of clinical trials, schedules of
IND, NDA, and other regulatory submissions, 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: 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 of financing, 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:
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Media Contact Investor Contact Corporate Contact
Jim Weinrebe, ext. 6650 Maria Zapf Boston Life Sciences, Inc.
Lauren Arnold, ext. 6514 Boston Life Sciences, Inc. Marc Lanser, MD
Schwartz Communications 617.425.0200 Chief Scientific Officer
781.684.0770 617.425.0200
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6
