Adherex Technologies Inc.

Adherex Technologies Inc.

March 24, 2005 08:08 ET

Adherex Receives Regulatory Clearance For Phase II Trial Of ADH-1 In Canada




MARCH 24, 2005 - 08:08 ET

Adherex Receives Regulatory Clearance For Phase II
Trial Of ADH-1 In Canada

Adherex Technologies Inc. (TSX:AHX)(AMEX:ADH), a biopharmaceutical
company with a broad portfolio of oncology products under development,
today announced that Health Canada has given regulatory clearance for
the Company's Phase II Clinical Trial Application (CTA) for ADH-1, the
Company's lead anti-tumor biotechnology compound, also known as
Exherin™. The Phase II trial, which is expected to involve up to
three cancer centers in Canada, will investigate repeated doses of ADH-1
in an every three week dosing schedule in patients whose tumors express
the molecular target N-cadherin.

Specifically, the Company will study eight different tumor types,
including some more common ones such as breast and lung, as well as some
rarer cancers such as adrenocortical and esophageal cancer. This trial,
the first in the Company's Phase II program, is expected to enroll up to
60 patients.

"This is a significant milestone for us and another one that we have
delivered on time," said William P. Peters, MD, PhD, Chairman and CEO of
Adherex. "In our Phase I trial, we have seen encouraging evidence of
anti-tumor activity even though most patients only received a single
dose of ADH-1. These observations have prompted us to proceed directly
into a Phase II program. It is unusual in Phase I trials to see the type
of rapid and durable responses that we have seen to date, and we are
committed to developing this drug as rapidly as possible."

The goals of the Phase II program, in which the Company expects to
enroll an aggregate of approximately 200 patients, and the ongoing and
planned Phase Ib/II trials are threefold: i) determine the optimal dose
and schedule for drug administration, ii) estimate the level of
anti-tumor activity in the selected tumor types, and iii) identify the
tumor types most suitable for future Phase III trials.

The Canadian Phase II trial is expected to begin enrolling patients in
the next quarter of 2005 at up to three sites and may conclude as early
as mid 2006.

About Adherex Technologies

Adherex Technologies Inc. is a biopharmaceutical company dedicated to
the discovery and development of novel cancer therapeutics. We aim to be
a leader in developing innovative treatments that address important
unmet medical needs in cancer. We currently have four products in the
clinical stage of development including ADH-1 (Exherin™) and sodium
thiosulfate (STS). ADH-1, our lead biotechnology compound, is an
angiolytic that selectively targets established blood vessels that feed
solid tumors. STS, a drug from our specialty pharmaceuticals pipeline,
protects against the disabling hearing loss that can often 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 is emerging as a
pioneering oncology company. For more information, please visit our
website at

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 clinical development plans of
the Company, and the expected timing and results. We can provide no
assurance that the clinical development will proceed as currently
anticipated or that the expected timing or results will be realized. We
are subject to the risks inherent in the biopharmaceutical industry,
including the early stage of our product candidates, the uncertainties
of clinical trials and regulatory review, and our history of losses. For
a more detailed discussion of related risk factors, please refer to our
public filings available at and


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