Adherex Receives Orphan Drug Designation for ADH-1 in Melanoma
- Additional centers to be added to ongoing Phase I/IIb trial -
Research Triangle Park, NC, February 2008 - Adherex Technologies Inc. (AMEX:ADH, TSX:AHX), a biopharmaceutical company with a broad portfolio of oncology products under development, today announced that it has received orphan drug designation for ADH-1 from the U.S. Food and Drug Administration (FDA). The designation was granted for the use of ADH-1 in conjunction with melphalan for the treatment of Stage IIB/C, III, and IV malignant melanoma. Adherex is currently conducting a Phase IIb expansion trial in melanoma using systemic ADH-1 in combination with regional melphalan.
“FDA orphan drug designation for ADH-1 is an important asset in Adherex’s development of this drug,” said Dr. William P. Peters, CEO and Chairman of Adherex. “Orphan drug designation provides multiple incentives for Adherex to continue its accelerated development of ADH-1 for this significant clinical problem. Melanoma is a disease with an extremely poor prognosis and one in which the molecular target for ADH-1, N-cadherin, is frequently and often intensively expressed. N-cadherin is also intimately involved in the invasion and metastasis of melanoma. Our experience to date combining ADH-1 and melphalan for the treatment of in-transit melanoma has been very encouraging. To continue with the rapid development of this combination, two additional centers, Lehigh Valley and H. Lee Moffitt, have joined our Phase IIb trial which is ongoing at Duke and the MD Anderson. All four participating institutions are first-class medical centers with experienced investigators, and we are very pleased to have them involved in this development program.”
The FDA orphan drug designation, administered by the Office of Orphan Products Development, provides potential incentives such as funding for clinical studies, study design assistance, waiver of FDA user fees, tax credits and, importantly, up to seven years of market exclusivity upon marketing approval.
Adherex is currently evaluating the synergy of systemic ADH-1 in combination with regionally-infused melphalan for the treatment of melanoma in a Phase I/IIb trial. The Lehigh Valley Hospital in Pennsylvania and the H. Lee Moffitt Cancer Center in Florida are being added as additional clinical trial sites to provide further multi-institutional experience. The Phase IIb portion of this trial is anticipated to complete patient accrual by approximately mid-2008, with data to be released at an appropriate scientific venue.
Another Phase I trial is also nearing completion at US Oncology in which systemic ADH-1 is being evaluated in combination with three different systemic chemotherapies: ADH-1 + docetaxel (Taxotere®), ADH-1 + carboplatin, and ADH-1 + capecitabine (Xeloda®). Subsequent Phase II and potential randomized, prospective trials of ADH-1 in combination with chemotherapy will be planned and based upon the results of the combination studies currently ongoing.
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