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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 2, 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
incorporation or organization) File No.) Identification 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 December 2, 1998, Boston Life Sciences, Inc. announced the initiation of a
preclinical development program for a newly-synthesized "second generation"
technetium-based compound, designated O-1506. This compound differs from the
Company's first generation compound, Altropane, in structure and in the
advantageous substitution of technetium for I123 as the radio-ligand. The
Company reported that O-1506 appears to demonstrate selectivity, binding
characteristics and brain striatal localization that look outstanding relative
to all other reported technetium-based compounds in this class. The Company
believes that the introduction of a user-friendly, technetium-based Parkinson's
diagnostic product has the potential to substantially increase the market for
these agents, particularly in early detection of the disease. The Company will
continue to focus on commercialization of Altropane in the United States, while
planning to develop O-1506 worldwide because of the potential for simpler
manufacturing and distribution considerations.
On December 11,1998, the Company announced that results achieved in animal model
experiments involving the Company's Central Nervous System (CNS) growth factor,
Axogenesis Factor 1 (AF-1), demonstrated re-growth of severed axons within the
optic nerve in mice. Since degenerative injury to the optic nerve produces the
destruction of vision suffered in glaucoma, the Company believes that these
preliminary successes suggest that AF-1 could potentially be used as a treatment
for this major cause of blindness in the developed countries. In these
experiments, the optic nerves in mice were partially severed and the mice were
then treated with one injection of AF-1 administered into the posterior chamber
of the eye. Treated animals showed histologic evidence of substantial optic
nerve regeneration across the lesion, whereas control animals showed
insignificant or no evidence of regeneration in their optic nerves. The Company
noted that a significant amount of additional work needs to be done to confirm
and elaborate these preliminary results as well as optimize drug delivery and
dosing.
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 2, 1998.
99.2 Press Release, dated December 11, 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: December 14, 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 December 2, 1998 4
99.2 Press Release, dated December 11, 1998 5
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Exhibit 99.1
FOR IMMEDIATE RELEASE
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BOSTON LIFE SCIENCES BROADENS PROMINENT POSITION IN DEVELOPMENT OF DIAGNOSTIC
AGENTS FOR PARKINSON'S DISEASE
DECEMBER 2, 1998--BOSTON, MA. BOSTON LIFE SCIENCES, INC. (NASDAQ: BLSI) whose
compound, Altropane/tm/ is the only diagnostic agent for Parkinson's Disease
currently in active advanced human clinical trials, announced that it has
initiated a preclinical development program for a newly-synthesized "second
generation" technetium-based compound (designated O-1506).
This compound differs from Altropane in structure and in the advantageous
substitution of technetium for I/123/ as the radio-ligand.
"In both in vitro and in vivo studies, O-1506 appears to demonstrate
selectivity, binding characteristics, and brain striatal localization that look
outstanding relative to all other reported technetium-based compounds in this
class," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. "Even as
Altropane continues to perform exceedingly well in our clinical trials, we
believe that the subsequent introduction of a user-friendly, technetium-based
Parkinson's diagnostic product has the potential to substantially increase the
market for these agents, particularly in early detection of the disease. The
ability to eventually follow Altropane to market, if approved, with a second-
generation technetium product would, in our view, give BLSI a long-term
competitive advantage in this rapidly emerging diagnostic area. While our
priority is to continue to focus on commercialization of Altropane in the U.S.,
we plan to develop O-1506 worldwide because of potentially simpler manufacturing
and distribution considerations," added Dr. Lanser.
The foregoing contains forward-looking statements with regard to product
development timelines and regulatory filings, which may not be realized due to
the uncertainties inherent in the research and development process.
BLSI is developing novel treatments for cancer, autoimmune disease, and central
nervous system disorders. In addition to Altropane and O-1506, 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; Troponin, an anti-angiogenic
treatment for cancer and eye diseases, 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' NERVE GROWTH FACTOR DEMONSTRATES POTENTIAL AS A NEW
TREATMENT FOR GLAUCOMA
BOSTON, MA--DECEMBER 11, 1998. BOSTON LIFE SCIENCES, INC. (NASDAQ: BLSI)
announced that results achieved in animal model experiments involving the
Company's Central Nervous System (CNS) growth factor Axogenesis Factor 1 (AF1)
demonstrated re-growth of severed axons within the optic nerve in mice. Since
degenerative injury to the optic nerve produces the destruction of vision
suffered in glaucoma, these preliminary successes suggest that AF1 could
potentially be used as a treatment for this major cause of blindness in the
developed countries, the Company said.
"To our knowledge, this is the first time that optic nerve regeneration has
reportedly been achieved by intraocular injection of a single nerve growth
factor. In these experiments, the optic nerves in mice were partially severed
and the mice were then treated with one injection of AF1 administered into the
posterior chamber of the eye. Treated animals showed histologic evidence of
substantial optic nerve regeneration across the lesion, whereas control animals
showed insignificant or no evidence of regeneration in their optic nerves.
Though much work needs to be done to confirm and elaborate these preliminary
results as well as optimize drug delivery and dosing, these exciting data
suggest that AF1 has the potential to be a totally novel approach to the
treatment of glaucoma," stated Dr. Marc E. Lanser, MD, Chief Scientific Officer
of BLSI. "This important in vivo activity of AF1 is consistent with both our
prior in vitro data demonstrating the potent axon regenerative activity of AF1,
and significantly complements our recently reported positive results in
experimental spinal cord axonal regeneration.
The Company's CEO, David Hillson commented, "Coming on top of our previously
reported positive results for Troponin as an anti-angiogenic approach to the
treatment of macular degeneration and diabetic retinopathy, we will want to
include our CNS program for consideration by potential ophthalmic partners.
Given our assessment of the importance of both of these recent experimental
successes, we now believe that the value of our CNS program could potentially
achieve equal status with our more well-known technologies."
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; AF1 and other nerve growth factors for the potential
treatment of stroke and spinal cord injury; Altropane, a radioimaging agent for
the diagnosis of Parkinson's Disease; 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, the implication of experimental results and eventual
clinical indications, any of which may not result in approved products due to
the uncertainties inherent in the research and development process.
For further information please contact:
Marc E. Lanser, MD
Chief Scientific Officer
617-425-0200
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