-----Oorspronkelijk bericht-----
Van: Pick Mahaffey <[log in to unmask]>
Aan: [log in to unmask] <[log in to unmask]>
Datum: donderdag 16 maart 2000 16:14
Onderwerp: PD diagnosis
Boston Life Sciences Announces Completion of Phase III Altropane Trial
Enrollment
http://biz.yahoo.com/bw/000315/ma_boston__1.html
Wednesday March 15, 11:42 am Eastern Time
Company Press Release
Boston Life Sciences Announces Completion of Phase III Altropane Trial
Enrollment
BOSTON--(BW HealthWire)--March 15, 2000--Boston Life Sciences, Inc.
(NASDAQ:BLSI - news) announced that enrollment in the Company's Phase III
trial for the use of Altropane to diagnose early Parkinson's Disease (PD)
has been completed. Approximately 160 patients were enrolled in 20 sites
throughout the U.S.
``We are pleased to have completed this milestone in the development of
Altropane to diagnose early PD. Completion of the trial and analysis of the
data will take place during the second quarter of this year, during which
time we will be working on our cGMP manufacturing capacity. We are looking
forward to filing for marketing approval later this year,'' stated Dr. Marc
Lanser, Chief Scientific Officer of BLSI.
``There is currently no objective test for PD. Clinical diagnosis of
early PD can be problematic, since studies have reported that as much as
25-30% of early cases may be misdiagnosed. The most common condition that
can be misdiagnosed as PD is Benign Essential Tremor, a condition which does
not require treatment and which does not respond to conventional PD therapy.
We believe that the use of Altropane in early PD will focus on increasing
the accuracy and timeliness of the diagnosis and thus facilitate earlier and
more appropriate treatment. This is especially true in younger individuals,
in whom the diagnosis of PD is ordinarily not readily considered,'' added
Dr. Lanser.
There are approximately 250,000 individuals per year in the U.S. who see
a physician because of the onset of a movement disorder. Of these, 50,000
patients per year are diagnosed with PD. The Company believes that the
market for Altropane for this indication could be $50-$75 million per year.
In addition to the PD indication, BLSI is developing Altropane for the
diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). The Company
plans to initiate a Phase II trial for the ADHD indication in the second
quarter of this year.
BLSI is developing novel diagnostics and therapeutics for Parkinson's
Disease and Attention Deficit Hyperactivity Disorder (ADHD) as well as
treatments for cancer, autoimmune disease, and central nervous system
disorders. BLSI's products in development include: Altropane, a radioimaging
agent for the diagnosis of Parkinson's Disease and ADHD; 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; novel therapies for the treatment of Parkinson's Disease
and ADHD; 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, discussions with regulatory agencies, schedules of IND, NDA
and all other regulatory submissions, the timing of product introductions,
the possible approval of products, and the market size 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: the availability and adequacy of financial resources, the ability
to obtain intellectual property protection, delays in the regulatory or
development processes, results of scientific data from clinical trials, the
outcome of discussions with potential partners, regulatory decisions, 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.
