SAN DIEGO, Nov. 9 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. announced today that it has initiated a Phase II clinical trial in Europe of its therapeutic vaccine Uvidem(R), under development in collaboration with Sanofi-Aventis, for the treatment of melanoma.
The trial will recruit 50 patients with resected stage II or III melanoma who will be randomized to receive either Uvidem alone (25) or Uvidem combined with peginterferon alpha-2b (ViraferonPeg(R), Schering-Plough) (25). Peginterferon alpha-2b has been approved in Europe for the treatment of hepatitis C, and is currently under development by Schering-Plough for the treatment of melanoma.
The primary objective of this trial is the evaluation of a specific immune response to the vaccine after treatment with Uvidem, with or without peginterferon alpha-2b. The secondary objectives are safety and disease free survival.
This European trial will be conducted in centers in France, Germany and the UK. IDM has obtained approval for the study from British and French health authorities and has requested approval from the German health authority.
Didier Landais, Ph.D., Uvidem project leader at IDM commented, “Peginterferon alpha-2b is a well known immuno-modulator that has been shown in clinical trials by others to have a positive impact as an immuno adjuvant in combination with melanoma vaccines. We anticipate that it may boost the immune response generated by Uvidem which could translate to more measurable clinical benefits for the patients enrolled in our clinical trials.”
A separate Phase II trial of Uvidem is ongoing in the United States in patients with stage III or IV melanoma. IDM recently began the second stage of that trial based on positive clinical results in the first stage.
About Melanoma
Melanoma is the most serious form of skin cancer. Around 60,000 new cases were diagnosed in 2002 in Europe and almost 17,000 people in Europe died from the disease (Globocan 2002). Almost 60,000 new cases are expected to be diagnosed this year in the U.S. and an estimated 7,770 people in the U.S. will die from the disease (American Cancer Society. Cancer Facts and Figures 2005. Atlanta: ACS; 2005).
About Uvidem
Uvidem is a therapeutic vaccine under development by IDM in collaboration with Sanofi-Aventis. The vaccine consists of mature dendritic cells loaded with lysates from melanoma tumor cell lines. The investigational vaccine is produced in the IDM manufacturing facilities in Irvine, California and Paris, France.
About IDM Pharma
IDM is a biopharmaceutical company focused on the development of innovative products that activate the immune system to treat cancer and infectious disease. IDM is currently developing three types of products: the first is designed to destroy cancer cells by activating innate immunity, the second to prevent tumor recurrence by triggering a specific adaptive immune response, and the third to treat chronic infectious disease with therapeutic vaccines.
IDM currently has 7 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 three are in Phase I in colorectal cancer, hepatitis B and HIV infection.
IDM has major product development partnerships with SANOFI-AVENTIS in cancer immunotherapy, and with INNOGENETICS in vaccine development for the treatment of chronic hepatitis B and C and papilloma virus infection. MEDAREX and SANOFI-AVENTIS have been corporate partners and shareholders of IDM or its affiliate since 1993 and 2001 respectively.
For more information, visit www.idm-pharma.com.
Forward-Looking Statements
This press release includes forward-looking statements that reflect management’s current views of future events, including the status of development of IDM’s Uvidem melanoma vaccine candidate and the Company’s other product candidates, the possible benefits of Uvidem in treating melanoma, with and without Peginterferon alpha-2b, and the potential market for therapies for melanoma. Actual results may differ materially from the above forward-looking statements due to a number of important factors, including but not limited to the possibility that Uvidem may not prove to be safe or show evidence of clinical activity in the current Phase II trials in Europe and the US, and that combining Uvidem with Peginterferon alpha-2b may not boost the immune response generated by Uvidem and may not translate to more measurable clinical benefits for the patients enrolled in our clinical trials. Other factors that could cause or contribute to differences in actual results include, but are not limited to, whether the Company or any of its collaborators will be able to develop pharmaceutical products using the technologies of the Company, 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; 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, including the collaboration with Sanofi-Aventis regarding Uvidem, and the Company’s dependence on intellectual property. These factors are more fully discussed in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2004, the Proxy Statement concerning the business combination of Epimmune Inc. and IDM S.A. filed with the Securities and Exchange Commission (SEC) on June 30, 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.
IDM Pharma, Inc.
CONTACT: Robert De Vaere, Chief Financial Officer of IDM, +1-858-860-2500
Web site: http://www.idm-pharma.com/
