Boston Life Sciences Acquires Rights to Develop and Commercialize Promising Phase II Spinal Cord Injury Drug, Cethrin(R), in Exc
04 1월 2007 - 11:26PM
PR Newswire (US)
Interim Results Report Drug's Safety and Possible Recovery of
Function After Debilitating Injury; FDA "Orphan Drug" Status
Provides Important Strategic Advantages; Conference Call Scheduled
for Friday, January 5, 2007 - 10:00 AM EST HOPKINTON, Mass., Jan. 4
/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 entered into an exclusive, worldwide license with BioAxone
Therapeutic Inc. of Montreal, Canada, to develop and commercialize
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. The license provides for an up-front
license fee, possible performance milestones, and on-going
royalties based on sales of Cethrin after approval. Cethrin was
designed to specifically target the cellular response to an acute
SCI, promote the re-growth of injured axons, and restore sensory
and motor function. Research in animal models has shown that
re-growth of injured axons after an SCI restores motor and sensory
function. In November 2006, BioAxone reported interim results from
a Phase I/IIa clinical trial of Cethrin in acute spinal cord injury
patients indicating drug safety, tolerability and the potential to
promote recovery of motor function and sensation. "The licensing of
Cethrin enables us to continue toward our goal of transforming BLSI
into a CNS-focused therapeutics company. We believe Cethrin, if
approved, could also be great news for the thousands of people who
suffer devastating spinal cord injuries every year," said BLSI
Chairman and Chief Executive Officer, Peter Savas. "Our primary
technology focus is on stimulating the growth of nerve axons to
help restore sensory and motor function after severe nerve damage
such as that which occurs in spinal cord injury, stroke or ocular
injury. This license represents another successful step in our
strategy to assemble, develop and commercialize compelling axon
regeneration technologies. In May 2006, we announced that we had
extended our portfolio of intellectual property related to
axon-regeneration through an agreement with Children's Hospital
Boston for technologies under development in the labs of Drs. Larry
Benowitz and Zhigang He. We believe that the license for Cethrin
and the licenses with Children's Hospital Boston position BLSI as a
potential leader in the pursuit of effective therapies to reverse
the effects of traumatic central nervous system injuries and
provide us with what we believe is one of the broadest sets of
technologies in the industry for achieving this aim." "After
conducting an exhaustive worldwide search of CNS candidates, we are
very enthusiastic about the licensing of Cethrin because we believe
it adds considerable tactical and strategic value to our new
product pipeline and intellectual property estate," commented Mark
Pykett, President and Chief Operating Officer. "Cethrin is a
clinical stage compound supported by what we believe are compelling
pre-clinical data, encouraging early clinical trial results and
Orphan Drug designation. If successfully developed and approved,
Cethrin could address a significant unmet medical need in acute
spinal cord injury." 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. According to BLSI Chief Medical Officer, Mark
Hurtt, "We believe the early efficacy findings are promising. 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. Further, the study
indicates that improvement in function may be dose dependent. We
plan to continue the existing trial protocol to explore this effect
in increasingly higher doses." 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. Other License Information The BioAxone
license agreement provides for an up-front license fee of $10
million payable in 2 installments ($2.5 million of which was paid
on execution and $7.5 million due on or before March 31, 2007),
possible performance milestones of up to $25 million, the majority
of which are due and payable only after approval and achievement of
certain specified sales goals, and on- going royalties based on
sales of Cethrin after approval. To fund the initial $2.5 million
of the license fee, the Company utilized borrowings available to it
under the promissory notes from Robert and Thomas Gipson. The
Company plans to secure additional debt or equity financing to fund
the $7.5 million remainder of the license fee. Conference Call
Details The company will host a conference call on January 5, 2007
at 10:00am EST to discuss the license agreement with BioAxone. To
access the conference call, please dial (719) 457-2621 domestic and
(800) 210-9006 internationally. The code for this conference call
is 1940703. A replay of the call will be available on the IR
section of our website, http://www.bostonlifesciences.com/, until
Friday, January 19, 2007. Glossary of Terms: ASIA Impairment Scale:
The extent of injury is defined by the American Spinal Injury
Association (ASIA) Impairment Scale (modified from the Frankel
classification), using the following categories: A - Complete: No
sensory or motor function is preserved in sacral segments S4-S5. B
- Incomplete: Sensory, but not motor, function is preserved below
the neurologic level and extends through sacral segments S4-S5. C -
Incomplete: Motor function is preserved below the neurologic level,
and most key muscles below the neurologic level have muscle grade
less than 3. D - Incomplete: Motor function is preserved below the
neurologic level, and most key muscles below the neurologic level
have muscle grade greater than or equal to 3. E - Normal: Sensory
and motor functions are normal. Axon: A long fiber of a nerve cell
(a neuron) that acts somewhat like a fiber-optic cable carrying
outgoing messages. The neuron sends electrical impulses from its
cell body through the axon to target cells. Each nerve cell has one
axon. An axon can be over 20 cm (a foot) in length. Dura mater:
Literally, hard mother (in Latin). The outermost, toughest, and
most fibrous of the three membranes (meninges) covering the brain
and the spinal cord. Orphan Drug Designation: Orphan Drug
designation is granted by the FDA's Office of Orphan Products
Development to a drug or biologic that is intended for use in a
rare disease or condition. A rare disease is classified as
effecting fewer than 200,000 in the United States. The Orphan Drug
Act was enacted to encourage the development of treatments for
these small patient populations by providing incentives: (1) seven
year market exclusivity to sponsors on approved products, (2) a
tax-credit of 50 percent of the cost of conducting clinical trials,
(3) federal research grants for clinical testing of new therapies
to treat and/or diagnose rare diseases, (4) exemption from PDUFA
application fees. 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, or 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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