Three New Clinical Trials Under Way
SOUTH SAN FRANCISCO, Calif., May 9 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today reported that three new clinical trials
for GVAX immunotherapy for leukemia are now under way in collaboration with
the Johns Hopkins Sidney Kimmel Cancer Center. The new trials are based on
encouraging results in an initial Phase 2 study of the product in patients
with chronic myelogenous leukemia (CML) and include:
-- A Phase 2 randomized trial in 56 patients with CML who have persistent
molecular evidence of disease following Gleevec(R)(imatinib) therapy
that will compare the combination of GVAX plus continued Gleevec to the
combination of interferon-alpha, GM-CSF plus continued Gleevec with
respect to the levels of bcr-abl, a well-established marker of residual
leukemia. The study will also compare the ability of each combination
therapy to permit a carefully monitored discontinuation of therapy in
those patients who achieve a sustained complete disappearance of
bcr-abl in order to determine the potential for disease eradication.
-- An extension study of the initial Phase 2 trial in 19 patients with CML
that will evaluate the efficacy of a second course of GVAX with respect
to inducing a complete disappearance of bcr-abl in the 11 patients who
responded to the first course of GVAX, but failed to achieve a
sustained complete response.
-- A Phase 1 trial in 18 patients with poor risk myelodysplastic syndrome
(MDS) with or without prior chemotherapy, that will evaluate response
to GVAX as measured by blood counts and transfusion requirements,
cytogenetics and levels of WT-1, a marker associated with leukemia.
The three new trials are being conducted by Hyam I. Levitsky, M.D.,
professor of Oncology Medicine and Urology, and colleagues at the Johns
Hopkins University School of Medicine and were described yesterday in a
presentation by Dr. Levitsky at the Sloan-Kettering Cancer Center in New
York City.
"We are encouraged by the results we have seen to date with GVAX
immunotherapy for leukemia and are pleased that our collaborators at Johns
Hopkins University are expanding the clinical program with these three new
important studies," stated Kristen Hege, M.D., vice president of Clinical
Research at Cell Genesys. "GVAX immunotherapy for leukemia, like our lead
product, GVAX immunotherapy for prostate cancer now in Phase 3 development,
is designed to stimulate the immune system as a means of treating cancer.
Moreover, GVAX immunotherapy for leukemia may prove to be useful in
multiple hematologic malignancies."
Cell Genesys reported at the annual meeting of the American Society of
Clinical Oncology (ASCO) in June 2006 encouraging long-term follow-up data
from a Phase 2 trial of GVAX immunotherapy for leukemia in CML. A total of
19 CML patients with molecular evidence of persistent leukemia following at
least one year of Gleevec therapy were treated with GVAX immunotherapy for
leukemia while continuing to receive Gleevec. Results showed that the
addition of GVAX immunotherapy to Gleevec therapy reduced persistent
leukemic disease in 10 of 19 patients as demonstrated by a complete
disappearance (five patients) or a greater than one log (90%) reduction
(five patients) in bcr-abl. The company also previously reported
encouraging clinical data from a Phase 2 trial of GVAX immunotherapy for
leukemia in patients with acute myelogenous leukemia (AML). Patients with
newly diagnosed leukemia were treated with chemotherapy, and if responsive,
subsequently received autologous bone marrow stem cell transplantation and
GVAX immunotherapy. The findings in this trial indicate that GVAX
immunotherapy was well-tolerated and may reduce residual leukemic cells
that persist after chemotherapy as indicated by decreased levels of WT- 1,
which is detectable in over 95 percent of patients with active AML.
Clinical trials of GVAX cancer immunotherapies are under way for
multiple types of cancer including, in addition to leukemia, prostate
cancer and pancreatic cancer. The products are comprised of tumor cells
that have been modified to secrete GM-CSF, an immune stimulatory hormone,
and then irradiated for safety. GVAX cancer immunotherapies are being
developed as non patient- specific "off-the-shelf" pharmaceutical products
and have demonstrated a favorable side effect profile in over 600 patients
treated in Phase 1 and 2 clinical trials to date.
Cell Genesys is focused on the development and commercialization of
novel biological therapies for patients with cancer. The company is
currently developing two clinical stage product platforms -- GVAX(TM)
cancer immunotherapies and oncolytic virus therapies. Ongoing clinical
trials include Phase 3 trials of GVAX immunotherapy for prostate cancer,
Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for
leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder
cancer. Cell Genesys continues to hold an equity interest in its former
subsidiary, Ceregene, Inc., which is developing gene therapies for
neurodegenerative disorders. Cell Genesys is headquartered in South San
Francisco, CA and has its principal manufacturing operation in Hayward, CA.
For additional information, please visit the company's website at
http://www.cellgenesys.com.
Statements made herein about the company, other than statements of
historical fact, including statements about the company's progress, results
and timing of clinical trials and preclinical programs and the nature of
product pipelines are forward-looking statements and are subject to a
number of uncertainties that could cause actual results to differ
materially from the statements made, including risks associated with the
success of clinical trials and research and development programs, the
regulatory approval process for clinical trials, competitive technologies
and products, patents, continuation of corporate partnerships and the need
for additional financings. For information about these and other risks
which may affect Cell Genesys, please see the company's Annual Report on
Form 10-K for the year ended December 31, 2006 filed on March 1, 2007 as
well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed
from time to time with the Securities and Exchange Commission. The company
assumes no obligation to update the forward-looking information in this
press release.
Contact:
Ina Cu
Investor Relations
650-266-3200
SOURCE Cell Genesys, Inc.
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Related links:
http://www.cellgenesys.com/
CONTACT:
Ina Cu, Investor Relations of Cell Genesys,
Inc., +1-650-266-3200
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