IDM Pharma Announces the Completion of Enrollment in Two Phase II Trials of Uvidem(R) in Melanoma
Wednesday February 28, 8:00 am ET
IRVINE, Calif.--(BUSINESS WIRE)--IDM Pharma, Inc. (Nasdaq: IDMI - News) announced today the completion of patient enrollment in two Phase II clinical trials of Uvidem, IDM's therapeutic product for the treatment of melanoma being developed in collaboration with sanofi-aventis. Thirty-eight patients with malignant melanoma were included in the US study and 53 patients with resected stage II/III melanoma were included in the European study.
"This is another in a series of important milestone achievements we have made in the company's development programs," said Bonnie Mills, PhD, VP, Clinical Operations and General Manager US Operations for IDM. "We thank the patients, physicians and their teams whose support and enthusiasm made this possible. We anticipate that we will be able to complete the analysis of these trials and provide initial results during 2007." The preliminary results of the DC-MEL-202 trial have been submitted for presentation at ASCO 2007 in Chicago.
About the clinical trials
The US clinical trial is designed to assess the safety and clinical activity of Uvidem in patients with stage III or IV melanoma with measurable lesions. Participating centers include the University of California Los Angeles (UCLA) Jonsson Comprehensive Cancer Center, the MD Anderson Cancer Center, the University of Pittsburgh, the Arizona Cancer Center and Lutheran General Cancer Care Center.
The primary objective of the European trial is the evaluation of a specific immune response against tumor antigens following treatment with Uvidem, administered with or without peginterferon alpha-2b in patients with resected stage II or III melanoma. Secondary objectives are safety and disease free survival. Ten participating clinical centers in Europe include sites in France (Institut Gustave-Roussy (Villejuif), Hopital Cochin-Tarnier (Paris), Hopital Michallon (Grenoble), Hopital Ste Marguerite (Marseilles), Centre Eugene Marquis (Rennes), Unit of Skin Cancer (Nantes), Hopital St Andre CHU (Bordeaux), Hopital St Louis (Paris), Hopital Claude Huriez (Lille))and the UK (Mount Vernon Hospital (London)).
About Uvidem
Uvidem is a therapeutic specific immunostimulant developed by IDM in partnership with sanofi-aventis, and sanofi-aventis has worldwide marketing rights to Uvidem in melanoma. Uvidem consists of mature dendritic cells loaded with lysates from melanoma tumor cell lines. Uvidem is produced in the IDM GMP manufacturing facilities in Irvine, California and in Paris, France. Uvidem in its different phases of clinical development has been injected to 143 patients. |
