Actualités

IDM Pharma Announces the Completion of Enrollment in Two Phase II Trials of Uvidem(R) in Melanoma

Publiée le 28/02/2007

IRVINE, Calif.--Feb. 28, 2007--IDM Pharma, Inc. (Nasdaq: IDMI) 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.

About Melanoma
Melanoma is the most serious form of skin cancer. Around 62,000 new cases were diagnosed in 2002 in Europe and almost 17,000 people in Europe died from the disease (Globocan 2002). In 2007, in the US, almost 59,940 new cases are expected to be diagnosed and it is estimated that approximately 8,110 people will die from the disease (American Cancer Society. Cancer Facts and Figures 2007. Atlanta: ACS; 2007).

About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About IDM Pharma
IDM Pharma (IDM) is a biopharmaceutical company focused on the development of innovative products that activate the immune system to treat cancer. IDM is currently developing two types of products: the first is designed to destroy cancer cells by activating innate immunity, and the second to prevent tumor recurrence by triggering a specific adaptive immune response.

IDM currently has five products in clinical development. The most advanced product, Junovan(TM), has completed a Phase III clinical trial in osteosarcoma. Three products are in Phase II clinical trials in bladder cancer, melanoma and non-small cell lung cancer, and one is in Phase I in colorectal cancer.

IDM has a major product development partnership with sanofi-aventis in cancer immunotherapy. Medarex and sanofi-aventis are corporate partners and shareholders of IDM or its affiliate since 1993 and 2001, respectively.

IDM Pharma Safe Harbor Statement

This press release includes forward-looking statements that reflect management's current views of future events including the timeframe for which the Company's cash will be sufficient to meet its operating requirements, statements regarding the filing and potential approval of the submissions for marketing approval of Junovan made with the FDA and the EMEA, and the Company's intention to contain its expenses and focus on its two lead product candidates. Actual results may differ materially from the above forward-looking statements due to a number of important factors, including, but not limited to, the timing of the FDA's and EMEA's review of the submissions for marketing approval, the ability of the Company to respond to questions raised by the FDA and EMEA in a satisfactory manner, the time needed to respond to any issues raised by the FDA and EMEA with regard to regulatory submissions for Junovan, the possibility that regulatory authorities may not consider preclinical and early clinical development work conducted by Ciba-Geigy and efficacy data from the Phase III trial conducted by Children's Oncology Group as adequate for their assessment of Junovan, which may cause delays in review, may result in the regulatory authorities requiring the Company to conduct additional clinical trials, or may result in a determination by the regulatory authorities that the data does not support marketing approval, whether regulatory authorities will approve Junovan within the time frame expected by the Company or at all, and whether the Company will be able to manufacture Junovan even if it is approved by regulatory authorities. Other risks affecting the Company and its drug development programs include whether the Company or any of its collaborators will be able to develop pharmaceutical products using the technologies of the company, whether clinical trial results to date are predictive of results of any future clinical trials, risks associated with completing clinical trials of product candidates, risks involved in the regulatory approval process for the Company's product candidates, the possibility that clinical testing may reveal undesirable and unintended side effects or other characteristics that may prevent or limit the commercial use of proposed products; whether the cash resources of the Company will be sufficient to fund operations as planned; whether any steps taken by the Company to contain costs will in fact result in sufficient reduction in expenses; reliance on key employees, especially senior management; the uncertainty of the Company's future access to capital; the risk that the Company may not secure or maintain relationships with collaborators, and the Company's dependence on intellectual property. These factors are more fully discussed in the Company's Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2005 and other periodic reports filed with the SEC. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

CONTACT: IDM Pharma, Inc.
Jackie Fritz, 949-470-4751
Senior Director Administration and Human Resources

SOURCE: IDM Pharma, Inc.