Adherex Announces Phase III Trial With STS in Collaboration With the Children's Oncology Group
March 26 2008 - 6:30AM
Marketwired
RESEARCH TRIANGLE PARK, NORTH CAROLINA (AMEX: ADH), a
biopharmaceutical company devoted to solving problems for patients
with cancer, announced today the activation of a Phase III trial
with sodium thiosulfate (STS) to prevent hearing loss in children
receiving cisplatin-based chemotherapy in collaboration with the
Children's Oncology Group (COG).
"The great progress that has been made in the curative
treatments of childhood cancer is often marred by the significant
long-term hearing disability that can result from the necessary
cisplatin treatment. The activation of this Phase III trial of STS
with the Children's Oncology Group is an important step in our
efforts to solve this problem for kids with cancer," said Dr.
William P. Peters, Chairman and CEO of Adherex. "Through this Phase
III trial and our ongoing Phase III trial with the International
Childhood Liver Tumour Strategy Group (known as SIOPEL), we aim to
globally recruit as many eligible children with cancer as quickly
as possible to help prevent the hearing loss that these children
and their parents have had to accept as part of their cancer
treatment."
"As many as 2,000 children with cancer are at risk for platinum
chemotherapy related hearing loss annually," said Dr. David Freyer,
Professor of Medicine, Childrens Hospital Los Angeles, Keck School
of Medicine of the University of Southern California and principal
investigator for the trial. "This hearing loss often leads to
long-term learning and developmental issues for these children.
With over 5,000 medical experts and over 200 participating
children's and university hospitals worldwide, the Children's
Oncology Group is very proud to offer its significant expertise and
resources to help improve the quality of life for children with
cancer."
"The clinical consequences of cisplatin related hearing loss are
frequent and significant," said Dr. Edward Neuwelt, Professor of
Neurosurgery, Oregon Health & Science University. "Our studies
have demonstrated that over 60 percent of children with cancer
receiving cisplatin therapy will develop some hearing loss, many
will require lifelong hearing aids, and some will become deaf. It
is common for these children to be 2-4 years behind their peers in
school. Younger children have been shown to have difficulty
acquiring language skills. I have been involved in the development
of STS for over a decade and am thrilled to see it entering
late-stage development. I believe that this drug may have the
ability to dramatically improve the long-term outcomes for these
children."
The goal of this Phase III study is to evaluate in a
multi-centered, randomized trial whether STS is an effective and
safe means of preventing hearing loss in children receiving
cisplatin chemotherapy for newly diagnosed germ cell, liver
(hepatoblastoma), brain (medulloblastoma), nerve tissue
(neuroblastoma) or bone (osteosarcoma) cancers. Eligible children
will be 1 to 18 years of age who are scheduled to receive cisplatin
according to their disease-specific regimen and, upon enrollment
onto this study, will be randomized to receive STS or placebo.
Efficacy of STS will be determined through comparison of hearing
sensitivity at follow-up relative to baseline measurements using
standard audiometric techniques. 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 providing drug and drug distribution for the study
and will have exclusive use of the results for regulatory
submissions. Adherex exclusively licensed intellectual property
rights directed to the use of STS as a chemoprotectant from Oregon
Health & Science University (OHSU) and received orphan drug
designation from the U.S. Food and Drug Administration (FDA) for
the use of STS for the prevention of platinum-induced ototoxicity
in pediatric patients. Investigators at OHSU have previously
conducted Phase I and Phase II studies with STS, which have shown
that STS can reduce the hearing loss associated with platinum-based
chemotherapy.
Adherex is also conducting a 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),
with centers in up to 33 countries expected to participate.
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.
About Oregon Health & Sciences University (OHSU)
Oregon Health & Science University is the state's only
health and research university, and Oregon's only academic health
center. OHSU is Portland's largest employer and the fourth largest
in Oregon (excluding government), with 12,400 employees. OHSU's
size contributes to its ability to provide many services and
community support activities not found anywhere else in the state.
It serves patients from every corner of the state, and is a conduit
for learning for more than 3,400 students and trainees. OHSU is the
source of more than 200 community outreach programs that bring
health and education services to every county in the state.
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: Weber Shandwick Worldwide Andrew Leopold / Felicia
Shiu 416-642-7949 / 416-642-7970 aleopold@webershandwick.com /
fshiu@webershandwick.com Judy Welage 212-445-8308
jwelage@webershandwick.com
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