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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 9, 1999
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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.)
137 Newbury Street
8th Floor
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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On November 9, 1999, the Company announced that its scientists at Children's
Hospital, Boston, reported in the Proceedings of the National Academy of
Sciences (PNAS) that a growth-promoting molecule known as Inosine stimulated
axon collateral growth to an extent never previously shown in an animal model
that has many features in common with spinal cord injury in humans.
In this model, one side of the corticospinal tract in rats was severed as it
courses through the brainstem. Inosine was then infused directly into the motor
cortex of the brain, the site of origin for those axons descending into the non-
injured side of the corticospinal tract. After 14 days of treatment, newly grown
axon branches were traced by injecting a dye into the treated nerve cells in the
cortex. Animals were then sacrificed and the spinal cord examined for histologic
evidence of new axon growth.
Almost all of the treated animals showed signs of extensive collateral sprouting
of axons from the uninjured to the injured side of the corticospinal tract
reaching below the level of the hemi-transection. These new axonal branches then
continued to descend down the injured side of the corticospinal tract,
effectively replacing severed axons with new ones. These axons were found to
enter the gray matter of the spinal cord in a normal fashion. The number of
collateral (new) axons ranged up to 2500 per treated animal, compared to 28-170
axons seen in control animals. This is the first time that such extensive
collateral growth in the corticospinal tract has been reported.
The Company stated that this is the first published study demonstrating that the
corticospinal tract can be extensively reconstituted following experimental
injury. Since corticospinal tract regeneration is an absolute prerequisite for
obtaining functional recovery after spinal injury in humans, the Company
believes that these published results demonstrate that it is in the
forefront in the search for potentially important therapeutic agents for spinal
cord injury. The Company believes that these compounds have the potential to
treat other acute and chronic degenerative CNS disorders, such as stroke,
Parkinson's Disease, and Alzheimer's. The Company hopes to bring one or more of
these molecules into clinical testing late next year.
On November 17, 1999, the Company announced that Dr. Larry Benowitz, Director of
the Laboratory for Neuroscience Research in Neurosurgery at Children's Hospital,
Harvard Medical School, has been awarded a grant from the Christopher Reeve
Paralysis Foundation to support his research in axonal regeneration in the
spinal cord. This financial assistance is in addition to the ongoing funding
from the Company.
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 9, 1999.
99.2 Press Release, dated November 17, 1999.
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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: November 19, 1999 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. Pages
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99.1 Press Release, dated November 9, 1999 4 - 5
99.2 Press Release, dated November 17, 1999 6
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Exhibit 99.1
CHILDREN'S HOSPITAL, BOSTON AND BOSTON LIFE SCIENCES REPORT EXTENSIVE AXONAL
REGENERATION IN MAJOR SPINAL CORD PATHWAY AFTER INJURY
- --Results of Animal Studies Reported in Proceedings of the National Academy of
Sciences--
Boston, MA--November 9, 1999--Scientists at Children's Hospital, Boston, have
reported that a growth-promoting molecule known as Inosine stimulated axon
collateral growth to an extent never previously shown in an animal model that
has many features in common with spinal cord injury in humans.
Dr. Larry Benowitz, senior author of the PNAS paper, said that he was rather
amazed at the level of axon growth observed in these studies, since most earlier
efforts using other approaches had shown very little growth of these axons
through the heavily myelinated region of the spinal cord. When his team first
observed the massive crossing of axons from the normal side of the spinal cord
into the injured side, Benowitz assumed that they were seeing some sort of
technical artifact. It was not until they confirmed their results in a number of
animals using independent methods, and after several colleagues looked at these
cases, that Benowitz realized that they had succeeded well beyond their original
expectations. The axon growth obtained in this model of corticospinal tract
injury is unprecedented. Inosine's ability to stimulate regrowth of axons into
areas of the spinal cord below a significant injury is a big step forward in
finding a treatment for spinal cord and other central nervous system injuries.
Dr. Benowitz, whose work in this area is sponsored by Boston Life Sciences, Inc.
and the NIH, is the Director of the Laboratories for Neuroscience Research in
Neurosurgery at Children's Hospital. Other investigators involved in this study
include David Goldberg, Joseph Madsen, Deepa Soni and Nina Irwin.
In this model, one side of the corticospinal tract in rats was severed as it
courses through the brainstem. Inosine was then infused directly into the motor
cortex of the brain, the site of origin for those axons descending into the non-
injured side of the corticospinal tract. After 14 days of treatment, newly grown
axon branches were traced by injecting a dye into the treated nerve cells in the
cortex. Animals were then sacrificed and the spinal cord examined for histologic
evidence of new axon growth.
Almost all of the treated animals showed signs of extensive collateral sprouting
of axons from the uninjured to the injured side of the corticospinal tract
reaching below the level of the hemi-transection. These new axonal branches then
continued to descend down the injured side of the corticospinal tract,
effectively replacing severed axons with new ones. These axons were found to
enter the gray matter of the spinal cord in a normal fashion. The number of
collateral (new) axons ranged up to 2500 per treated animal, compared to 28-170
axons seen in control animals. This is the first time that such extensive
collateral growth in the corticospinal tract has been reported.
The corticospinal tract, whose axons originate far up in the motor cortex of the
brain and then descend down the length of the spine, controls almost all motor
function in the human body. Under normal circumstances, the fiber pathways that
run from the higher centers of the brain down to the spinal cord are not able to
grow back after injury. As a result of this, people with injury to the spinal
cord, or with injury to the descending pathways that send projections to the
spinal cord, can permanently lose their ability to control the body's movements.
The corticospinal tract carries signals from the highest centers of the cerebral
cortex that program voluntary movement down to the nerve cells in the spinal
cord that activate the muscles of the fingers, hands, legs and feet. This
pathway is required for everyday functions ranging from writing or playing an
instrument to walking. Therefore, only agents which specifically stimulate
regenerative axon growth extending down the corticospinal tract have the
potential to be of therapeutic benefit in humans with spinal cord injuries.
Until this study, there have been only a few published reports of comparatively
small amounts of regeneration in the corticospinal tract. Consequently, this
all-important region has been thought to be
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nearly totally unresponsive to nerve regenerative therapies. The significance of
this study is that it shows, for the first time, that the corticospinal tract
indeed appears capable of extensive axon growth if treated with the appropriate
nerve growth factor.
"This is the first published study demonstrating that the corticospinal tract
can be extensively reconstituted following experimental injury," stated Marc E.
Lanser, MD, Chief Scientific Officer of Boston Life Sciences, Inc. "Since
corticospinal tract regeneration is an absolute prerequisite for obtaining
functional recovery after spinal injury in humans, we believe that these
published results, as well as similar unpublished results obtained with another
CNS growth factor sponsored by us at Children's, demonstrate that BLSI is in the
forefront in the search for potentially important therapeutic agents for spinal
cord injury. We believe that these compounds have the potential to treat other
acute and chronic degenerative CNS disorders, such as stroke, Parkinson's
Disease, and Alzheimer's. We hope to bring one or more of these exciting
molecules into clinical testing late next year," added Dr. Lanser.
Inosine, the compound that stimulated this unprecedented level of growth in the
spinal cord, is a naturally occurring substance found in small amounts in cells
throughout the body. Dr. Benowitz' group previously found that Inosine could
stimulate nerve cells in culture to regrow damaged nerve fibers (axons). It
apparently acts by passing directly into nerve cells and activating part of the
cell's genetic program to grow an axon. Prior to this work, Inosine was best
known to biochemists as a molecule that is formed by the breakdown of adenosine,
an essential building block of DNA and RNA and an important signaling molecule
in its own right. The current study is the first to examine whether Inosine
would have similar effects on axon growth when tested directly in an animal
model of brain injury.
"We are delighted with the recognition received by Children's Hospital and Prof.
Benowitz through publication of his work in PNAS. We feel privileged to have our
CNS program now accorded the level of scientific interest recently received by
the company's Antiangiogenesis and Parkinson's/ADHD technologies. We believe
that BLSI is heading into 2000 with the bases loaded," stated David Hillson,
President and CEO.
Children's Hospital, Boston, is the nation's premier pediatric medical center.
Founded in 1869 as a 20-bed hospital for children, today it is a 300-bed
comprehensive center for pediatric and adolescent health care grounded in the
values of excellence in patient care and sensitivity to the complex needs and
diversity of children and families. Children's Hospital is the primary pediatric
teaching affiliate of Harvard Medical School, home to the world's leading
pediatric research enterprise, and the largest provider of health care to the
children of Boston.
BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders. In addition to Inosine, BLSI's products awaiting FDA
review, in clinical trials or in preclinical development include Therafectin(R),
an oral drug for the treatment of Rheumatoid Arthritis; Altropane(TM) an imaging
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 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.
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 Exhibit 99 to the Company's Annual Report on Form
10-K/A.
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Exhibit 99.2
BOSTON LIFE SCIENCES' COLLABORATING SCIENTIST RECEIVES GRANT
FROM CHRISTOPHER REEVE PARALYSIS FOUNDATION
Dr. Benowitz of Children's Hospital, Boston receives two year grant to expand
spinal cord regeneration research
November 17, 1999--Boston, MA--Boston Life Sciences, Inc. (NASDAQ: BLSI)
announced that Dr. Larry Benowitz, Director of the Laboratory for Neuroscience
Research in Neurosurgery at Children's Hospital, Harvard Medical School, has
been awarded a grant from the Christopher Reeve Paralysis Foundation to support
his research in axonal regeneration in the spinal cord. This financial
assistance is in addition to the ongoing funding from BLSI.
Dr. Benowitz is the senior author of a manuscript published in the current issue
of the Proceedings of the National Academy of Sciences which describes the
unprecedented regeneration of axons in the corticospinal tract of the spinal
cord following experimental transection. This regrowth was achieved using
Inosine, a naturally-occurring small molecule licensed to BLSI by Children's
Hospital in Boston.
"The award of this highly competitive grant by the Christopher Reeve Paralysis
Foundation is further evidence of the scientific importance of Dr. Benowitz'
work in this field. This grant should help Dr. Benowitz expand the underlying
science research in Inosine, which in turn may allow BLSI to accelerate the
preclinical studies necessary to support the filing of an Investigational New
Drug (IND) application for the use of Inosine to treat spinal cord injuries and
stroke," stated Marc E. Lanser, MD, Chief Scientific Officer of BLSI.
BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders. In addition to Inosine, BLSI's products awaiting FDA
review, in clinical trials or in preclinical development include Therafectin(R),
an oral drug for the treatment of Rheumatoid Arthritis; Altropane(TM) an imaging
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 and AF-1 for the treatment of acute and
chronic CNS disorders.
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 Exhibit 99 to the
Company's Annual Report on Form 10-K/A.
For further information, please contact:
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Media Contact Analyst Contact Corporate Contact
Jim Weinrebe, ext. 6650 Neil Berkman Boston Life Sciences, Inc.
Lauren Arnold, ext. 6514 Neil Berkman Associates Marc Lanser, MD
Schwartz Communications 310-277-5162 Chief Scientific Officer
781-684-0770 617-425-0200
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