The data includes 30 patients who received an aggregate of over 200 doses (68 cycles) of ADH-1 given on a weekly schedule with doses ranging from 150 to 2400 mg/m2. ADH-1 was well tolerated at all doses tested for periods of up to eight months, displayed predictable pharmacokinetics, and demonstrated hints of anti-tumor activity in five patients with advanced, chemotherapy-resistant cancer. A maximum tolerated dose was not defined.
"This European data is consistent with our prior clinical experience, showing ADH-1 to be well tolerated over a broad dosage range with hints of anti-tumor activity in a variety of tumor types," said William P. Peters, MD, PhD, Chairman and CEO of Adherex. "Given the unexpected level of synergy of ADH-1 in combination with chemotherapy that we have reported from our preclinical studies, the clinical development of this drug continues fully on track. We expect to have results from the North American Phase II trial with single-agent ADH-1 as well as initial results from our ongoing Phase I combination studies with ADH-1 and chemotherapy available later this year."
In the European Phase Ib/II study, three of 19 patients (16%) with ovarian/gynecological tumors experienced evidence of anti-tumor activity, one with an unconfirmed partial response (previously reported) and two with prolonged stabilization of their disease, which were previously rapidly progressive (eight and six months, respectively). Two other patients experienced stabilization of their disease, one with colorectal cancer and one with non-small cell lung cancer, each lasting three months.
Adherex is currently evaluating the synergy of ADH-1 in combination with chemotherapy in a Phase I trial of ADH-1 in three separate combinations: ADH-1 + docetaxel (Taxotere(R)), ADH-1 + carboplatin, and ADH-1 + capecitabine (Xeloda(R)). A Phase I study of ADH-1 in combination with melphalan for the treatment of melanoma is expected to initiate in the coming weeks. In addition to the European Phase Ib/II study of single-agent ADH-1 to be presented today, the Company has also completed patient enrollment in a North American Phase II study of single-agent ADH-1 and data from that trial is expected to be presented at an appropriate scientific venue in 2007.
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 multiple products in the clinical stage of development, including eniluracil, ADH-1 and sodium thiosulfate (STS). Eniluracil, an oral dihydropyrimidine dehydrogenase (DPD) inhibitor, was previously under development by GlaxoSmithKline for oncology indications. ADH-1, our lead biotechnology compound, selectively targets N-cadherin, a protein present on certain tumor cells and 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 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 and results of such 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 in 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.
SOURCE: Adherex Technologies Inc.
Adherex Technologies Inc.
Director, Corporate Communications