IDM Pharma, Inc.
(Nasdaq: IDMI) announced updated results from the Phase 2 study of
its investigational agent IDM-2101 which showed the vaccine was well
tolerated, induced broadly specific cytotoxic T lymphocyte (CTL) responses,
and showed a positive survival trend in patients with non-small cell lung
cancer (NSCLC) who were vaccinated with IDM-2101, compared to a parallel
external control group of non-vaccinated patients.
The data will be presented during an oral session on Sunday, November 4
at 8:45 a.m. EST at the International Society for Biological Therapy of
Cancer (iSBTc) annual meeting in Boston.
"We are encouraged by the positive trend in overall survival we are
seeing in patients who were treated with IDM-2101," said Minal Barve, M.D.,
practice director, Mary Crowley Cancer Research Center. "We believe that
the survival trend, as well as the tolerability and robust immunological
response data, warrant further examination to confirm the treatment
benefits of IDM-2101 for patients with non-small cell lung cancer."
Trial Design and Results
The Phase 2 open label, non-randomized trial with one year follow-up
for survival was designed to assess overall survival and vaccine
immunogenicity in HLA-A2 positive patients with stage IIIb, IV or recurrent
non-small cell lung cancer. Patients were required to have tumor volume
less than 125 cm squared with no limits on prior chemotherapy. Sixty-eight
patients were enrolled in the trial (sixty-three treated with one or more
doses) with the last patient enrolled in March 2006.
Updated one-year survival in patients treated with IDM-2101 was 60
percent, compared to 49 percent in a group of seventy-two patients who were
HLA-A2 negative but otherwise comparable (external comparator group).
Median survival for patients treated with IDM-2101 was 17.3 months compared
to 12.0 months for patients in the comparator group. Ninety-one percent of
patients treated with IDM-2101, who were tested for immune response, had a
measurable response to at least one of the epitopes included in the vaccine
with 64 percent responding to at least three of the epitopes. Toxicities
attributable to the vaccine were mild and consisted primarily of injection
site reactions.
"We are very encouraged by the continued positive survival trend and
safety results of IDM-2101 in this study and are eager to continue
development of this novel treatment," said Timothy P. Walbert, president
and chief executive officer, IDM Pharma, Inc. "We will move forward with
our plan to use the final results from this trial, which we expect next
year, as a basis in determining an appropriate clinical pathway for
IDM-2101."
About IDM-2101
IDM-2101 includes nine CTL epitopes from four tumor associated antigens
(TAA) including two proprietary native epitopes and seven modified, or
analog, epitopes and one universal epitope a source of T-cell help.
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 2 IDM-2101 study has
been ongoing since late 2004 and the last patient is expected to be treated
in May 2008.
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
213,000 new lung cancer cases will be diagnosed in the United States in
2007, and an estimated 160,000 patients will die from lung cancer. The
American Cancer Society also estimates that non-small cell lung cancer
represents 87 percent of all lung cancers.
In the European Union, non-small cell lung cancer represents 75 percent
of all lung cancer. In addition, approximately 130,000 new cases will be
diagnosed in 2007 in the top five markets (France, Germany, Italy, UK &
Spain)
About IDM Pharma
IDM Pharma is focused on the development of innovative cancer products
that either destroy cancer cells by activating the immune system or prevent
tumor recurrence by triggering a specific adaptive immune response. IDM
Pharma is dedicated to maximizing the full therapeutic and commercial
potential of each of its innovative products to address the needs of
patients and the physicians who treat these patients.
For more information about the company and its products, 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 2 IDM-2101 study, the support that the survival data and positive
safety profile and immunological data from the Phase 2 IDM-2101 provides
for further clinical evaluation of IDM-2101, and the potential for IDM-2101
as a treatment for non-small cell lung cancer. Actual results may differ
materially from the forward-looking statements due to a number of important
factors, including, but not limited to, 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, and the
Company's dependence on intellectual property. These factors and others
affecting the Company's business are more fully discussed in the Company's
Quarterly Report on Form 10-Q filed with the SEC for the quarter ended June
30, 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