RESEARCH TRIANGLE PARK, NORTH CAROLINA (TSX: AHX), a
biopharmaceutical company devoted to solving problems for patients
with cancer, announced today the publication of an abstract on the
phase I/II study of ADH-1 in combination with isolated limb
infusion melphalan as a treatment for melanoma. The abstract was
prepared for the 2008 American Society of Clinical Oncology (ASCO)
Annual Meeting, which takes place May 30 - June 3, 2008 in Chicago,
IL.
The abstract, which is reproduced below, highlights initial
human data indicating that the synergy previously noted in our
preclinical studies is also being seen in the clinic. Regional
infusion of melphalan alone for melanoma has historically led to
complete responses in about thirty percent of cases. Using ADH-1 in
combination with regionally-infused melphalan, the melanoma tumors
appear to be more vulnerable to the chemotherapy with compete
responses being noted in approximately half of the patients in the
study thus far.
As of May 16, 2008, 33 patients had been enrolled in the study.
As reported in a WRAL interview with Dr. Georgia Beasley,
independent lead investigator on the study at the Duke
Comprehensive Cancer Center (available at
http://www.wral.com/business/local_tech_wire/biotech/story/2897670/),
eight of the initial 16 patients had in field complete responses at
three months following treatment. Data on an aggregate of
approximately 20 patients with three month follow-up will be
presented June 1st in a poster discussion session at the 2008 ASCO
annual meeting in Chicago.
The incidence of malignant melanoma is increasing at a rate
faster than any other cancer, with 60,000 new cases expected to be
diagnosed this year in the United States. Melanoma that has spread
beyond the primary site is rarely curable, and treatment options
are limited. Even when it is treated, the response rates are
typically poor, and most people die within six to nine months after
diagnosis.
Adherex is evaluating ADH-1 in combination with melphalan via
isolated limb infusion for the treatment of melanoma in an ongoing
multi-institutional Phase I/IIB trial. Current participating
centers include Duke University Medical Center, MD Anderson Cancer
Center, Lehigh Valley Hospital and H. Lee Moffitt Cancer Center,
with four additional centers in the process of being added. We
currently expect the trial to enroll a total of 56 patients.
Earlier this year, Adherex was granted orphan drug designation
for the use of ADH-1 in conjunction with melphalan for the
treatment of Stage IIB/C, III and IV malignant melanoma.
The full abstract reads as follows :
"Title: A phase I/II study of systemic ADH-1 in combination with
isolated limb infusion with melphalan (ILI-M) in patients (pts)
with locally advanced in-transit melanoma.
Abstract No: 9013
Citation: J Clin Oncol 26: 2008 (May 20 suppl; abstr 9013)
Author(s): G. Beasley, N. McMahon, G. Sanders, P. Zipfel, C.
Augustine, W. Petros, J. Padussis, M. I. Ross, A. Selim, W. Peters,
D. S. Tyler
Background: ILI-M is a well tolerated treatment for pts with
in-transit melanoma of the extremity with a 30% CR rate in our own
cohort of 50 previously treated pts. ADH-1 is a cyclic pentapeptide
that targets N-cadherin adhesion complexes. In a preclinical model
of melanoma treatment with ILI-M, the combination of systemic ADH-1
and regional melphalan resulted in a synergistic increase in
durable CRs. Methods: A phase I/II study was performed to evaluate
the safety, tolerability, pharmacokinetics, and anti-tumor activity
of systemic ADH-1 in combination with ILI-M in pts with measurable
in-transit melanoma of the extremity. The initial phase I study
consisted of ADH-1 dose escalation cohorts of 3 pts each at 1.0,
2.0, and 4.0 gm administered systemically on Days 1 (6-8 hr pre
ILI-M) and 8 in combination with standard dose ILI-M corrected for
ideal body weight. The phase II study expanded the 4.0 gm ADH-1
cohort to 25 pts. N-cadherin IHC staining was performed on
pretreatment tumor tissue. Response was defined at 3 months using
RECIST criteria.
Results: Eleven pts, including 6 previous ILI-M alone failures,
have been treated with no observed dose limiting toxicities. Common
treatment related grade 1/2 toxicities included pain (n equals 8),
skin/dermatologic (n equals 11), musculoskeletal (n equals 4), and
nausea (n equals 4). Grade 3 toxicities included neutropenia (n
equals 1), anemia (n equals 1), and serologic CPK elevation (n
equals 1). There was 1 Grade 4 CPK elevation. To date, in field
responses of the 7 pts followed 3 months post treatment include 4
CRs (57%), 1 SD, and 2 PDs. Interestingly, the 2 pts with PD had
tumors that were negative for N-cadherin by IHC. PK analysis
demonstrated minimal variability in melphalan plasma levels across
pts while ADH-1 plasma concentrations immediately pre-ILI-M
increased with each dose cohort (mean equals 901 ng/mL at 1.0 gm,
1,985 ng/mL at 2.0 gm, and 11,491 ng/mL at 4.0gm.). Conclusions:
Systemic ADH-1 administered pre and post ILI-M is a well tolerated,
novel targeted therapeutic approach to regionally advanced
melanoma. Tumor responses, especially CRs, exceeded expectations in
this group of heavily pretreated pts and appear to require
N-cadherin expression. Complete accrual to the study is expected by
May 2008."
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, that
previous results will be predictive of future outcomes 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 Email:
info@adherex.com Website: www.adherex.com
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