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FOR FURTHER INFORMATION
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Robert De Vaere Lars Glassen Tricia Ross
Chief Financial Officer General Information Investor/Analyst Information
(858) 860-2500 (310) 854-8313 (617) 520-7064
lglassen@financialrelationsboard.com tross@financialrelationsboard.com
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FOR IMMEDIATE RELEASE
SEPTEMBER 7, 2005
IDM ANNOUNCES FINAL RESULTS OF PHASE 1 THERAPEUTIC AIDS VACCINE STUDY
AT AIDS VACCINE 2005 INTERNATIONAL CONFERENCE
SAN DIEGO, SEPTEMBER 7, 2005 - IDM PHARMA, INC. (IDM) (NASDAQ: IDMI), formerly
Epimmune Inc., today announced the final results of the Phase 1 clinical trial
of its EP HIV-1090 DNA vaccine in 40 HIV-1-infected individuals with full
suppression of HIV-1 replication on stable anti-retroviral therapy. Results were
presented at the AIDS Vaccine 2005 International Conference in Montreal, Canada
by Dr. Cara Wilson. IDM, holder of the IND, completed the clinical testing in
collaboration with Dr. Cara Wilson, University of Colorado Health Sciences
Center (UCHSC), and Dr. Constance Benson, formerly with UCHSC at the inception
of the trial and currently at the University of California, San Diego. The trial
opened to accrual in October 2002, all subjects completed vaccine immunization
and clinical follow-up in October 2004, and immune response testing was
completed in August 2005.
Subjects were randomized to receive either vaccine, at doses of 0.5, 1, 2 or 4
mg, or placebo. At each dose level 8 patients received vaccine and 2 received
placebo. Vaccine treatment or placebo was administered at 0, 4, 8, and 16 weeks
for a total of 4 doses. Signs and symptom-directed physical examinations were
obtained at screening, baseline, every 4 weeks until completion of the vaccine
schedule, then at weeks 24 and 40. Safety laboratory assessments included
hematology, serum CPK, serum creatinine, AST, ALT, alkaline phosphatase, total
bilirubin, CD4+ T lymphocyte count, and plasma HIV-1 RNA levels at screening,
entry, and at weeks 2, 6, 10, 18, 24 and 40, and an autoimmune profile at entry
and week 24. The final vaccine/placebo administration was at week 16 with
post-vaccination follow-up continued for an additional 6 months after the last
dose; the total study duration for each patient was 10 months. No patients
experienced a Grade 3 or 4 toxicity judged to be study vaccine/placebo-related
and median CD4+ T lymphocyte counts remained stable. Thus, cytotoxic T
lymphocyte (CTL) epitope vaccines based on DNA were determined to be safe in
HIV-1-infected individuals based on results of the study.
Vaccine immunogenicity was tested using peripheral blood mononuclear cell (PBMC)
samples obtained at pre-entry, entry, baseline, and at weeks 4, 8, 16, 18, 24,
and 40 using the ELISPOT, with and without peptide restimulation, to determine
if significant responses were induced. The observed responses were often highest
during the vaccine administration period (weeks 0 - 16) although responses were
detected up to 24 weeks after the final vaccination in some (4) vaccinated
individuals. Of the 32 patients in the trial that received vaccine, 10 responded
in a manner that met
criteria for being "vaccine responders" based on a post-vaccine response of
greater than or equal to three times the pre-vaccine response to two or more
epitopes. Only one responding patient was in the placebo group. Five additional
patients responded to a single new epitope. Thus, epitope-specific CTL were
induced in a subset of patients. The EP HIV-1090 DNA vaccine induced new CTL
responses in 15 of 32 (47%) patients.
Dr. Mark Newman, Vice President of Infectious Diseases at IDM said, "This Phase
1 clinical study proved to be very encouraging because we were able to document
DNA vaccine safety and the utility of DNA vaccines for the delivery of multiple
CTL epitopes in an immunogenic form in HIV-1-infected individuals. The EP
HIV-1090 DNA vaccine is the first product of this type developed by IDM and our
pipeline contains several `next generation' products, including recombinant
proteins and a viral vector that should be useful for increasing vaccine
potency. We firmly believe epitope-based vaccine technology can be applied to
numerous therapeutic vaccines designed to treat chronic infectious diseases and
cancer."
ABOUT IDM
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 are corporate partners and shareholders of IDM or its affiliate
since 1993 and 2001 respectively.
For more information, visit www.idm-pharma.com.
FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements that reflect management's
current views of future events, including statements regarding the potential
benefits of the Company's EP HIV-1090 therapeutic vaccine, the support the data
from the Company's Phase 1 HIV trial provides for the Company's multi epitope
approach to inducing an immune response, the ability of an epitope-based vaccine
to prevent or treat HIV infection, the safety and efficacy of epitope-based
products in humans, the utility of `next generation' products, including
recombinant proteins and a viral vector for increasing vaccine potency, and the
applicability of epitope-based vaccine technology to other therapeutic vaccines
designed to treat chronic infectious diseases and cancer. Actual results may
differ materially from the above forward- looking statements due to a number of
important factors, including but not limited to whether in vitro re-stimulation
reflects the levels of CTL activity that could be achieved were the CTL exposed
to the HIV antigens naturally, whether results in any subsequent clinical study
will be consistent with results from the Phase 1 study, whether the Company will
be
able to increase vaccine potency, whether the Company's technologies will be
useful in developing other therapeutic vaccines to treat chronic infectious
diseases and cancer, whether the Company will have sufficient funding available
to support further development of its vaccine candidates, whether the Company or
any of its partners is able to develop pharmaceutical products using epitopes or
analog epitopes, the regulatory approval process, the possibility that the FDA
may comment or raise concerns or questions with respect to any IND or IND
amendment the Company files and, therefore, clinical trials may not begin when
planned, the possibility that the Company's clinical studies may not provide the
FDA with sufficient clinical data to permit proceeding to the next stage of
clinical development of a new drug even though the Company believes it is doing
the right studies based on the protocol, the possibility that testing may reveal
undesirable and unintended side effects or other characteristics that may
prevent or limit the commercial use of proposed products, 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/A for the year ended December 31, 2004, the Proxy
Statement 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.
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