Adherex Announces Agreement for STS Phase III Data
14 5월 2008 - 9:30PM
Marketwired
RESEARCH TRIANGLE PARK, NORTH CAROLINA (AMEX: ADH), a
biopharmaceutical company devoted to solving problems for patients
with cancer, announced today a license agreement with the
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
(NKI-AVL) for the exclusive use of data from a Phase III trial
conducted by Dr. Charlotte Zuur and colleagues of the NKI-AVL with
sodium thiosulfate (STS) to prevent hearing loss in adults with
head and neck cancer, published in the Journal of Clinical Oncology
in August 2007 and entitled "Ototoxicity in a Randomized Phase III
Trial of Intra-Arterial Compared With Intravenous Cisplatin
Chemoradiation in Patients with Locally Advanced Head and Neck
Cancer". The agreement includes an exclusive license to data from a
planned study intended to provide long-term follow-up on the
hearing status, disease-free status and overall survival of
patients from the completed Phase III trial.
"This agreement and the long-term follow-up data are valuable
additions to our ongoing STS Phase III studies with SIOPEL and the
Children's Oncology Group and our planned trial in adult head and
neck cancer patients," said Dr. William P. Peters, Chairman and CEO
of Adherex. "As many as 2,000 children and up to 30,000 adults in
the U.S. alone are at risk for platinum chemotherapy related
hearing loss annually. With this trial, we will have safety and
efficacy data for an aggregate of more than 550 patients in our
ongoing and completed Phase II and Phase III studies."
"Cisplatin related hearing loss is frequent, significant and
irreversible," said Dr. Charlotte Zuur of the Netherlands Cancer
Institute. "Our studies have indicated that STS can significantly
prevent the hearing loss commonly seen with cisplatin therapy, with
a reduction in the need for hearing aids noted in our study, and
without jeopardizing the effectiveness of the chemotherapy in these
patients."
As previously reported in the Journal of Clinical Oncology, the
NKI-AVL Phase III trial included 158 randomized patients with head
and neck cancer being treated with cisplatin and demonstrated a 13%
reduction in the need for hearing aids with no effect on
progression-free and overall survival at two years. The goal of the
planned follow-up study is to further evaluate hearing status,
disease-free status and overall survival in these patients at
approximately five years.
Adherex is currently evaluating STS in a multi-centered,
randomized Phase III trial in collaboration with Children's
Oncology Group (COG) in children receiving cisplatin chemotherapy
for newly diagnosed germ cell, liver (hepatoblastoma), brain
(medulloblastoma), nerve tissue (neuroblastoma) or bone
(osteosarcoma) cancers. The trial is expected to enroll up to 120
patients over approximately three years in up to 230 COG centers in
the United States, Canada, Australia and Europe. Adherex is also
conducting a multi-centered, randomized Phase III trial of STS in
children with liver (hepatoblastoma) cancer in collaboration with
the International Childhood Liver Tumour Strategy Group (known as
SIOPEL), a multi-disciplinary group of specialists under the
umbrella of the International Society of Pediatric Oncology (SIOP),
which is expected to enroll up to 100 patients in centers in up to
33 participating countries.
About Adherex Technologies
Adherex Technologies Inc. is a biopharmaceutical company
dedicated to the discovery and development of novel cancer
therapeutics. We are in the business of solving problems for
patients with cancer. We have multiple products in the clinical
stage of development, including eniluracil, ADH-1 and sodium
thiosulfate (STS). Eniluracil, an oral dihydropyrimidine
dehydrogenase (DPD) inhibitor, is being developed to improve the
tolerability and effectiveness of 5-fluorouracil (5-FU), one of the
most widely used oncology drugs in the world. ADH-1 is a
biotechnology compound which selectively targets N-cadherin, a
protein present on certain tumor cells and the blood vessels of
solid tumors. STS is a chemoprotectant being developed to reduce or
prevent hearing loss that may result from treatment with
platinum-based chemotherapy drugs. With a diversified portfolio of
unique preclinical and clinical-stage cancer compounds and a
management team with expertise in identifying, developing and
commercializing novel cancer therapeutics, Adherex aims to become a
leader in developing innovative treatments that address important
unmet medical needs in cancer. For more information, please visit
our website at www.adherex.com.
This press release contains forward-looking statements that
involve significant risks and uncertainties. The actual results,
performance or achievements of the Company might differ materially
from the results, performance or achievements of the Company
expressed or implied by such forward-looking statements. Such
forward-looking statements include, without limitation, those
regarding the development plans of the Company and the expected
timing or results of our development. We can provide no assurance
that such development will proceed as currently anticipated or that
the expected timing or results of such development will be
realized. We are subject to various risks, including the
uncertainties of clinical trials, drug development and regulatory
review, the early stage of our product candidates, our reliance on
collaborative partners, our need for additional capital to fund our
operations, our history of losses, and other risks inherent to the
biopharmaceutical industry. For a more detailed discussion of
related risk factors, please refer to our public filings available
at www.sedar.com and www.sec.gov.
Contacts: Adherex Technologies Inc. D. Scott Murray Senior Vice
President, Corporate Development 919-484-8484 info@adherex.com
Adherex (AMEX:ADH)
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