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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) January 26, 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.)
31 Newbury Street, Suite 300
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 January 26, 1999, the Company announced that it had completed an interim
analysis of the Phase II trial of Altropane, its radioimaging agent for the
early diagnosis of Parkinson's Disease ("PD"). The interim results from about
one half of the total number of enrolled subjects indicate that the subjects
with early or mild PD can be reliably and easily differentiated from normal
subjects based on the Altropane scan results. The Company believes that the PD
subjects entered into the current trial resembled quite closely the patient
population that potentially would be candidates for Altropane scanning if and
when the agent becomes commercially available. The Company noted that the Phase
III trial has been designed to test the ability of Altropane to discriminate
between early Parkinson's syndromes and other movements disorders, a distinction
which often poses diagnostic problems for practicing clinicians.
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 January 26, 1999.
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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: January 27, 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. Page(s)
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99.1 Press Release, dated January 26, 1999 4
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Exhibit 99.1
FOR IMMEDIATE RELEASE
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BOSTON LIFE SCIENCES ANNOUNCES INTERIM RESULTS FOR ITS PHASE II TRIAL OF
PARKINSON'S DISEASE DIAGNOSTIC AGENT ALTROPANE
JANUARY 26, 1999, BOSTON, MA--BOSTON LIFE SCIENCES, INC. (NASDAQ: BLSI)
announced that the Company had completed its interim analysis of the Phase II
trial of Altropane, its radioimaging agent for the early diagnosis of
Parkinson's Disease. The trial was designed to demonstrate that subjects with
early and/or mild Parkinson's Disease could be readily differentiated from
normal subjects based on an Altropane brain scan. This trial was different from
the Company's previously reported successful physician's sponsored Phase II
trial in that PD subjects in the current trial had clinically mild disease as
compared to the more advanced disease evaluated in the previous trial. The PD
subjects entered into the current trial consequently resembled quite closely the
patient population that potentially would be candidates for Altropane scanning
if and when the agent became commercially available, the Company said.
The interim results from about one half the total number of enrolled subjects
indicate that subjects with early or mild PD can be reliably and easily
differentiated from normal subjects based on the Altropane scan results. Normal
subjects had a mean striatal binding potential of 1.07 + 0.17 vs 0.44 + 0.19 for
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patients with early/mild PD (p is less than 0.00007). The highest binding
potential for a PD subject (0.66) was still well below the lowest binding
potential seen in the normal subjects (0.9). Qualitative assessment of the scans
revealed moderate to marked decrease in at least one quadrant of the striatum in
the brain of PD subjects compared to the normal subjects.
"We are gratified but frankly not surprised by these preliminary excellent
results of the interim Phase II analysis," stated Marc E. Lanser, MD, Chief
Scientific Officer of BLSI. "We had expected, based on the published studies of
academic groups, that Altropane would be able to reliably differentiate subjects
with mild PD from normal subjects. Having confirmed our expectations with these
results, we can now proceed with added confidence to our Phase III study. The
Phase III trial has been designed to test the ability of Altropane to
discriminate between early Parkinson's syndromes and other movement disorders, a
distinction which often poses diagnostic problems for practicing clinicians,"
added Dr. Lanser.
BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders. In addition to Altropane, BLSI's products awaiting
FDA review, in clinical trials or in preclinical development include
Therafectin, an oral drug for the treatment of Rheumatoid Arthritis; 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.
The foregoing contains certain forward-looking statements with regard to
projected or estimated dates for certain stages of product development, which
may not be realized due to the uncertainties inherent in the research and
development and regulatory processes.
For additional information contact:
Marc E. Lanser, MD
Chief Scientific Officer
617-425-0200
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