IRVINE, Calif., May 30 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. today announced that data from a Phase II UVIDEM(R) melanoma vaccine clinical trial and data from the Phase II EP-2101 non-small cell lung cancer (NSCLC) vaccine clinical trial will be presented at the 2007 American Society of Clinical Oncology (ASCO) 43rd annual meeting in Chicago on June 1-5 2007.
UVIDEM presentation details: -- “Clinical and immunological responses in patients with malignant melanoma treated with a dendritic cell-based vaccine. Preliminary report from a multi-institutional phase II clinical trial.” Abstract # 3004, Session: Developmental Therapeutics: Immunotherapy. Oral presentation by Merrick I. Ross, M.D., Professor of Surgery, Chief, Melanoma Section, Department of Surgical Oncology at M. D. Anderson Cancer Center. -- June 5, 2007 at 7.45 AM -- Location: E354a EP-2101 presentation details: -- “Phase II trial of a 10-epitope CTL vaccine, EP-2101, in metastatic NSCLC patients.” Abstract # 3068, Session: Developmental Therapeutics: Immunotherapy. Poster presentation. -- June 3, 2007, 8.00 AM - 12 PM -- Location: S Hall A2
About the UVIDEM(R) Clinical Trial
The U.S. 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
About the EP-2101 Clinical Trial
The U.S. clinical trial is designed to assess overall survival and vaccine safety, with vaccine immunogenicity as a secondary endpoint in HLA-A2+ patients with stage IIIb, IV or recurrent non-small cell lung cancer, or NSCLC. The trial design was an open label, non-placebo trial with one year follow-up for survival. Sixty-four patients were enrolled in the trial with the last patient enrolled in March 2006.
About UVIDEM(R)
UVIDEM is a therapeutic specific immunostimulant developed by IDM Pharma in partnership with sanofi-aventis. 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 IDM Pharma GMP manufacturing facilities in Irvine, California and in Paris, France. UVIDEM has been administered to 143 patients in clinical development. Completion of patient enrollment in two Phase II clinical trials was previously announced. Thirty-eight patients with malignant melanoma were included in the US Phase II study and 53 patients with resected stage II/III melanoma were included in the European randomized Phase II study.
About EP-2101
The EP-2101 cancer vaccine candidate used in this trial includes nine CTL epitopes from four tumor associated antigens (TAA) including two proprietary native epitopes and seven modified, or analog, epitopes. Tolerance to TAA, which is a failure of the immune system to recognize the cancer as diseased tissue, is broken by using these analog epitopes which enhance the potency of the T cell response. PADRE(R), a universal HTL epitope we have licensed from Pharmexa, is also included in the vaccine as an immunostimulant. The phase II EP-2101 study has been ongoing since late 2004.
About Melanoma
According to the American Cancer Society, in 2007 approximately 59,940 new cases are expected to be diagnosed and it is estimated that approximately 8,110 people in the United Sates will die from the disease.
About Lung Cancer
Cancer of the lungs continues to be a major health problem with a very high mortality rate and represents the leading cause of cancer death in the United States. According to the American Cancer Society, approximately 213,380 new lung cancer cases will be diagnosed in the United States in 2007, and an estimated 160,390 patients will die from lung cancer. The American Cancer Society also estimates that non-small cell lung cancer, or NSCLC, represents 87% of all lung cancers.
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’s lead product candidate, JUNOVAN(TM) (mifamurtide for injection), known as MEPACT in Europe, is part of a new family of immunotherapeutic agents designed to destroy residual cancer cells by activating the body’s natural defenses. IDM’s applications requesting marketing approval of JUNOVAN for use in the treatment of newly diagnosed resectable high-grade osteosarcoma patients in combination with multiple agent chemotherapy are in review by the U.S. Food and Drug Administration, or FDA, in the United States and by the European Medicines Agency, or EMEA, in Europe. IDM is jointly developing UVIDEM, a cell-based vaccine product candidate in Phase II clinical trials for the treatment of melanoma, with sanofi-aventis. EP-2101 is currently being tested in non-small cell lung cancer (NSCLC) patients in a Phase II clinical trial and is composed of multiple tumor-specific CTL epitopes selected from tumor-associated antigens
For more information, visit http://www.idm-pharma.com.
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 organization, 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 and in New York .
Forward-Looking Statements
This press release includes and the presentation described in this press release will include forward-looking statements that reflect management’s current views of future events including statements regarding the phase II UVIDEM study and the potential for UVIDEM as a treatment for melanoma and the phase II EP-2101 study and the potential for EP-2101 as a treatment for NSCLC, and review of the submissions for marketing approval of JUNOVAN by the FDA and the EMEA. Actual results may differ materially from the 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, although the FDA is not bound by the decision of any advisory panel, the possible negative impact that the opinion of the FDA’s Oncologic Drug Advisory Committee that the results of the Company’s Phase III trial do not provide substantial evidence of effectiveness of JUNOVAN in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy would have upon the determination by the FDA whether to approve the marketing application for JUNOVAN, which would have a material and adverse affect on IDM’s business, 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 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, 2006 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: Bob De Vaere IDM Pharma, Inc. Chief Financial Officer Office: 949-470-6447
IDM Pharma, Inc.
CONTACT: Bob De Vaere, Chief Financial Officer of IDM Pharma, Inc.,+1-949-470-6447
Web site: http://www.idm-pharma.com/
