Adherex Announces Updated ADH-1 Chemotherapy Combination Data in Melanoma
Research Triangle Park, NC, June 2008 - Adherex Technologies Inc. (AMEX:ADH, TSX:AHX), a biopharmaceutical company dedicated to solving problems for patients with cancer, announced today updated results from its ongoing Phase I/II study of ADH-1 in combination with isolated limb infusion melphalan for the treatment of melanoma which were presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. ADH-1 is a novel peptide which targets N-cadherin mediated cell adhesion being developed by Adherex to enhance the cytotoxic effects of chemotherapy.
In a poster discussion session at ASCO yesterday, data on the first 16 patients in the Phase I/II trial were presented, six patients from the completed Phase I portion of the trial and 10 patients from the ongoing Phase II portion of the trial. As of today, 35 patients have been enrolled on the trial and a total of 20 patients have now completed the minimum three months of follow-up. Of these 20 patients, a total of 10 have experienced in-field complete response (CR) as measured at three months. The trial is expected to enroll a total of 56 patients in up to eight participating centers.
“The combination of systemic ADH-1 and regional melphalan has resulted in about a 65% increase in the frequency of in-field CR over our prior experience with melphalan alone,” said Dr. Douglas Tyler, a surgeon at the Duke Comprehensive Cancer Center and the Durham Veterans Affairs Medical Center, and senior investigator on the Phase I/II study. “If these results combining ADH-1 and melphalan can be confirmed in a randomized trial, I believe it would represent a significant clinical advance for these patients"
Regional infusion of melphalan alone for the treatment of melanoma has historically led to complete response in about 30% of patients at Duke. ADH-1 in combination with regionally-infused melphalan has shown in-field compete response in 50% of the patients thus far as measured at three months from treatment.
“Targeting N-cadherin to augment the cytotoxic effects of chemotherapy is an entirely novel strategy for treating melanoma,” said Dr. William P. Peters, Chairman and CEO of Adherex. “According to the key opinion leaders we have consulted, these results represent a sufficient improvement over the current standard of care to warrant further investigation in a randomized trial. We are reviewing the current and evolving data to properly plan and design such a trial.”
“In-transit melanoma represents an entry indication for ADH-1, which we estimate to be as much as a US$300 million market opportunity. However, the recent preclinical and clinical work conducted at Duke has been invaluable to increasing our understanding of how to use ADH-1 in many different cancers,” continued Dr. Peters. “Ongoing studies in melanoma will provide important proof-of-concept and mechanism of action data that will facilitate further combinations and cancer indications for clinical investigation with ADH-1.”
“Approximately half of all cancers, including melanoma, lung, breast, colon, ovarian and liver cancers, express N-cadherin and thus represent potential targets for ADH-1. A common disease worldwide, melanoma remains an area of significant unmet need in cancer. While we believe the opportunity in melanoma is important in and of itself, we would expect to progressively expand our ADH-1 development programs into further cancer indications where it would be expected to have similar synergistic benefit and where we believe major market opportunities exist,” added Dr. Peters.
Abstract no. 9013, entitled “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,” was presented yesterday at ASCO in a poster presentation by Dr. Georgia Beasley, Duke University Medical Center. The poster was subsequently discussed in a poster discussion session by Dr. Jeffrey Gershenwald, MD Anderson Cancer Center. A copy of the ASCO poster is available on the Adherex 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 our development plans, the expected results of our development, and the potential markets and indications for our drug ADH-1. We can provide no assurance that development will proceed as currently anticipated, that previous results will be predictive of future outcomes, or that the expected markets or indications for ADH-1 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.
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