YM BIOSCIENCES ANNOUNCES FDA LIFTS CLINICAL HOLD ON AEROLEF(R) AND CLEARANCE OF A PHASE II CLINICAL TRIAL
2008年6月20日 - 6:00AM
PRニュース・ワイアー (英語)
- Dr. Ali Raza To Lead Further Development Of AeroLEF As President
Of AeroLEF Division - MISSISSAUGA, ON, June 19
/PRNewswire-FirstCall/ -- YM BioSciences Inc.
(AMEX:YMIAMEX:TSX:AMEX:YMAMEX:AIM:AMEX:YMBA), an oncology company
that identifies, develops and commercializes differentiated
products for patients worldwide, today announced that the Clinical
Hold imposed by the US Food and Drug Administration (FDA) on the
development of YM's AeroLEF(R) has been lifted. The lifting of this
Hold permits YM to resume the expansion into the US of the Phase II
clinical development of AeroLEF. AeroLEF is being developed as a
novel and effective approach to the management of acute pain by
delivering a proprietary formulation of inhaled, nebulized,
free-and-liposome-encapsulated fentanyl. The free fentanyl results
in rapid onset of analgesia while the liposome-encapsulated
fentanyl produces the unique extended duration of pain relief. The
FDA cleared a Phase II protocol in June 2007 to proceed with
AeroLEF's first trial in the US, however, immediately prior to the
End-of-Phase II meeting scheduled and held in January 2008, the FDA
imposed a Clinical Hold, now lifted. YM is also pleased to announce
that Dr. Ali Raza has been engaged as President of the AeroLEF
Division to lead the product's further development. Dr. Raza has
held a number of leadership roles in established and
development-stage pharmaceutical companies. He led the global
development of CRESTOR(R) (rosuvastatin), a product approved in
more than 60 countries and which is competing for market leadership
with Lipitor(R). Earlier this year he achieved regulatory clearance
for and initiated a major Phase III clinical program for a fentanyl
product being developed in more than 50 research centers in Europe.
"I am delighted to have joined the AeroLEF team at YM BioSciences
and look forward to moving rapidly to the late-stage, international
development of this unique product," said Dr. Raza. "We welcome Dr.
Raza and have high confidence that his breadth of experience in
global drug development will significantly reinforce our team's
ability to realize the substantial value of AeroLEF's unique
approach to the treatment of pain. The scientific pedigree and
unique advantages of this product have been established and safety
and efficacy data have been reported from previous clinical trials,
including in three poster presentations at the Annual Meeting of
the American Pain Society in May 2008," said David Allan, Chairman
and CEO. "We also greatly appreciate the timely review by the FDA
to our responses and the constructive approach of the Agency."
About YM BioSciences YM BioSciences Inc. is an oncology company
that identifies, develops and commercializes differentiated
products for patients worldwide. In addition to AeroLEF, the
Company's other late-stage product, nimotuzumab, is a humanized
monoclonal antibody that targets the epidermal growth factor
receptor (EGFR). It is approved in several countries for treatment
of various types of head and neck cancer. This press release may
contain forward-looking statements, which reflect the Company's
current expectation regarding future events. These forward-looking
statements involve risks and uncertainties that may cause actual
results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not
limited to, changing market conditions, the successful and timely
completion of clinical studies, the establishment of corporate
alliances, the impact of competitive products and pricing, new
product development, uncertainties related to the regulatory
approval process and other risks detailed from time to time in the
Company's ongoing quarterly and annual reporting. Certain of the
assumptions made in preparing forward-looking statements include
but are not limited to the following: that nimotuzumab will
continue to demonstrate a competitive safety profile in ongoing and
future clinical trials; that AeroLEF(TM) will continue to generate
positive efficacy and safety data in future clinical trials; and
that YM and its various partners will complete their respective
clinical trials within the timelines communicated in this release.
We undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise. DATASOURCE: YM BioSciences Inc.
CONTACT: Enquiries: James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Email: ; Thomas Fechtner, the Trout Group LLC, Tel.
(646) 378-2931, Email: ; Nominated Adviser, Canaccord Adams
Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500
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