Boston Life Sciences Completes Final License Fee Payment for Exclusive, Worldwide Rights to Develop and Commercialize Phase II S
27 März 2007 - 5:33PM
PR Newswire (US)
Company gains sole responsibility for Cethrin development
HOPKINTON, Mass., March 27 /PRNewswire-FirstCall/ -- Boston Life
Sciences, Inc. (NASDAQ:BLSI), a biotechnology company focused on
diagnostic and therapeutic products for central nervous system
disorders, announced today that it has paid the final $7.5 million
license fee installment for Cethrin. Under the previously disclosed
exclusive, worldwide license with BioAxone Therapeutic Inc. of
Montreal, Canada, BLSI assumes development and commercialization of
Cethrin, as well as other specified compounds subject to the
license, to treat acute spinal cord injury (SCI) and other serious
central nervous system disorders. In addition to the up-front
license fee now paid, the license provides for possible performance
milestones, and if approved, on- going royalties based on sales of
Cethrin. "Since we announced the licensing of Cethrin in January,
we have been working closely with BioAxone's team to facilitate an
orderly transfer of the technology, pre-clinical and clinical data,
clinical materials, regulatory documents and a host of critical
clinical site and vendor relationships, as well as continuation of
the monitoring of the ongoing Phase I/IIa clinical study in acute
spinal cord injury. Payment of this final license fee installment
enables us to assume full responsibility for the Cethrin program
from here forward and to pursue our clinical development and
commercial goals for the product" said Mark Pykett, the Company's
President and Chief Operating Officer. About Cethrin Cethrin is a
recombinant protein drug intended to facilitate the re-growth of
axons during the critical period immediately after a major injury
to the spinal cord. Following an SCI, about two-thirds of patients
undergo decompression/stabilization surgery. In this surgery,
Cethrin is delivered in a single dose directly onto the dura mater
of the injured region of the spinal cord without the need for
further invasive procedures. Positive interim results from a Phase
I/IIa clinical trial with Cethrin were recently reported. The
primary endpoint of the open-label trial was to demonstrate the
safety and tolerability of Cethrin in patients who have suffered a
complete cervical or thoracic spinal cord injury. A total of 37
patients was enrolled at nine centers in the US and Canada at
Cethrin doses between 0.3 mg and 6.0 mg. Results from a six-week
follow up indicated the treatment was safe and well tolerated. The
study also had an efficacy component based on the American Spinal
Injury Association's (ASIA) scale for assessment of sensory and
motor function in patients. The reported interim data indicate
that, after six weeks, 31 percent of patients recovered some
sensory and/or motor function below the level of their injury and
improved from a complete ASIA A injury to a less severe injury on
the ASIA scale. The U.S. Food and Drug Administration (FDA) has
designated Cethrin as an "Orphan Drug". The Company believes that
this designation could provide BLSI considerable strategic
advantages. Orphan Drug designation gives the Company seven-year
market exclusivity after FDA approval, waives select fees and
streamlines the requirements for clinical development, potentially
helping to accelerate the approval process and reduce costs. Orphan
Drug designation also provides certain tax advantages. There are
approximately 11,000 new cases of SCI each year in the US. The
average age of injury is 38. The estimated health care and living
costs that are directly attributable to SCI vary greatly according
to severity of the injury. The National Spinal Cord Injury
Statistical Center estimates that the direct lifetime care costs
for a patient with the most-severe injury and complete loss of
function below the injury site is $2.9 million. That figure is
dramatically reduced for people who have partial function, with
current estimates in the $650,000 range. Restoring even limited
function to those who otherwise would have complete loss of
function could reduce total medical costs by millions of dollars
each year and dramatically improve the quality of life for patients
and their families. About Boston Life Sciences, Inc. Boston Life
Sciences, Inc. (BLSI) is engaged in the research and clinical
development of diagnostic and therapeutic products for central
nervous system (CNS) disorders. ALTROPANE(R) molecular imaging
agent is in Phase III clinical trials for the diagnosis of
Parkinsonian Syndrome (PS) and Phase II clinical trials for the
diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). The
company's research and pre-clinical CNS programs include Inosine
for the treatment of stroke, a DAT blocker for the treatment of
Parkinson's disease, and a second generation technetium-based
molecular imaging agent for PS and ADHD. BLSI's current research
collaborations include Harvard Medical School and Children's
Hospital Boston. Safe Harbor The foregoing release contains certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward- looking
statements include statements regarding Boston Life Sciences'
future expectations, beliefs, intentions, goals, strategies, plans
or prospects regarding the future, including the Company's
licensing arrangement with BioAxone, including the development and
commercialization of Cethrin, the prospects of the Company's CNS
therapeutics program, the Company's strategies to develop and
commercialize axon regeneration technologies and the breadth of the
Company's technologies and intellectual property portfolio.
Forward- looking statements can be identified by terminology such
as "anticipate," "believe," "could," "could increase the
likelihood," "estimate," "expect," "intend," "is planned," "may,"
"should," "will," "will enable," "would be expected," "look
forward," "may provide," "would" or similar terms, variations of
such terms or the negative of those terms. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors including those risks, uncertainties and factors referred
to in the Company's Quarterly Report on Form 10-Q for the quarter
ended September 30, 2006 filed with the Securities and Exchange
Commission under the section "Risk Factors," as well as other
documents that may be filed by Boston Life Sciences from time to
time with the Securities and Exchange Commission. As a result of
such risks, uncertainties and factors, the Company's actual results
may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking
statements contained herein. Boston Life Sciences is providing the
information in this press release as of this date and assumes no
obligations to update the information in this press release. BLSI
Contacts: Meredith Patin - Investors 508-497-2360 ext. 239 Sharon
Correia - Media 508-497-2360 ext. 224 DATASOURCE: Boston Life
Sciences, Inc. CONTACT: Investors, Meredith Patin, +1-508-497-2360
ext. 239, Media, Sharon Correia, +1-508-497-2360 ext. 224, both of
Boston Life Sciences, Inc. Web site:
http://www.bostonlifesciences.com/
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