IDM Pharma, Inc.
(Nasdaq: IDMI) today announced that interim data from the Phase II study of
EP-2101 showed the vaccine was well tolerated and suggested a survival
benefit in patients with non-small cell lung cancer (NSCLC) who were
vaccinated with EP-2101 compared to concurrent non-vaccinated patients. In
addition, generation of a robust immune response was also demonstrated. The
data were presented at the 2007 American Society of Clinical Oncology
(ASCO) 43rd annual meeting in Chicago.
"We are encouraged by the favorable trend that suggests a survival
benefit in those patients who received the vaccine compared to those who
did not," said Dr. John Nemunaitis, Executive Director of the Mary Crowley
Medical Research Center. "We believe this survival data, along with the
positive safety profile and immunological data, support further clinical
evaluation of EP-2101 in a randomized trial to confirm this benefit."
Trial Design and Results
The open label, non-randomized trial with one year follow-up for
survival is designed to assess overall survival at one year and vaccine
safety, with vaccine immunogenicity as a secondary endpoint, in HLA-A2
positive patients with stage IIIb, IV or recurrent non-small cell lung
cancer. Sixty-eight patients were enrolled in the trial (sixty-three
treated) with the last patient enrolled in March 2006.
The interim analysis was conducted to assess the effect of EP-2101 on
overall patient survival in HLA-A2 positive stage IIIb, IV or recurrent
NSCLC patients. Patients were also required to have tumor volume less than
125 cm2 with no limits on prior chemotherapy.
One-year survival in patients treated with EP-2101 was 60%, compared to
49% in a group of patients who were HLA-A2 negative but otherwise
comparable (concurrent controls). Median survival for patients treated with
EP-2101 was 583 days compared to 361 days for patients in the control
group. Ninety-one percent of patients treated with EP-2101, who were tested
for immune response, had a measurable response to at least one of the
epitopes included in the vaccine with 64% responding to at least three of
the epitopes.
"This is a novel approach to treating lung cancer patients and these
positive interim results are reassuring as we continue to develop this
treatment," said Timothy P. Walbert, President and Chief Executive Officer,
IDM Pharma. "We plan to use this trial in determining an appropriate
clinical pathway for EP-2101 as both a single-agent and in combination with
other immune modulating therapies."
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. The phase II EP-2101 study has
been ongoing since late 2004.
About Lung Cancer
Lung cancer 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 under 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 idm-pharma.
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 EP-2101 study, the support that the survival data and positive
safety profile and immunological data from the phase II EP-2101 provides
for further clinical evaluation of EP-2101, and the potential for EP-2101
as a treatment for non-small cell lung cancer, 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 of JUNOVAN, 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, including any further clinical trials of any of the Company's
product candidates; 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 Quarterly Report on Form 10-Q filed with the SEC for the
quarter ended March 31, 2007 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.
idm-pharma