Blood Cancer &
 Leukemia

Leukemia Cancer News - Return to Menu

GVAX® cancer vaccine for acute leukemia

GVAX® cancer vaccine for acute leukemia is a vaccine comprised of the patient's irradiated tumor cells (collected prior to chemotherapy) mixed with a non patient-specific GVAX® product manufactured at Cell Genesys. As with all GVAX® products, cells have been genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone that plays a key role in stimulating the body's immune response to vaccines. The goal of GVAX® vaccine therapy in this setting is to stimulate an immune response directed against the patient's own tumor and to enhance the anti-leukemia activity of standard chemotherapy and transplantation.

Data from the multicenter Phase 2 trial of GVAX® leukemia vaccine, which enrolled 54 patients, were reported at the May 2005 American Society of Clinical Oncology (ASCO). To date, 28 patients have initiated GVAX® vaccination after achieving a complete response to chemotherapy and thus far 21 of these patients have completed the stem cell transplantation and initiated a series of post-transplant vaccinations. The majority of patients had detectable W-1 levels in their blood following chemotherapy, indicating persistent leukemic cells. There were post-vaccination declines in WT-1 in 11 of 16 patients (69%) in the blood and in 12 of 20 (60%) in the bone marrow after just a single pre-transplant vaccination.

In addition, two-year relapse-free survival was greater in the 11 patients who showed a decrease in WT-1 in the blood following the single pre-transplant vaccination compared to those who did not (73% vs. 0%, log-rank p=0.03) and was also greater in the 19 patients who achieved an undetectable level of WT-1 in the blood following stem cell transplantation and further vaccination compared to the six patients who did not (89% vs. 17%, log-rank p=0.02). Finally, all six patients who mounted a vaccine-associated immune response, as measured by induction of a delayed-type hypersensitivity reaction to their own leukemic cells, have remained in complete remission from 16 to 29 months post transplant and all six of these patients have had a vaccine-associated WT-1 decline or undetectable levels at the time of vaccination. To date, there have been no serious side effects considered related to the vaccine therapy.

Preclinical studies supporting the new Phase 2 trial were published in a May 2000 issue of the journal, Blood. Cell Genesys collaborators at Johns Hopkins University reported that in animal studies of acute leukemia, GVAX® cancer vaccine could be administered following bone marrow transplantation and significantly prevented tumor relapse thereby increasing the therapeutic benefit of transplantation. Tumor-free survival rates were approximately 80 percent in animals receiving the combination of GVAX® vaccine and transplantation, 40 percent in animals receiving vaccination alone and zero percent in animals receiving neither treatment. Additionally, GVAX® vaccination resulted in the sustained production of an expanded population of tumor-specific immune cells, thereby redirecting the immune system to recognize and destroy tumor cells.

(The data referenced in the preceding paragraphs represent the most recently announced data pertaining to this program.)

Information About GVAX® Cancer Vaccine for Acute Leukemia Clinical Trials Currently Under Way:

" K-0009 (fully enrolled): Vaccination in Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia: The Use of Autologous Tumor Cells with an Allogeneic GM-CSF Producing Bystander Cell Line.

http://www.cellgenesys.com/clinicaltrials-leukemia.shtml

Cell Genesys Reports Additional Positive Data From Phase 2 Trial of GVAX® Vaccine For Leukemia

Reduction in Residual Leukemic Cells Following Vaccination

ORLANDO, FL., May 16, 2005Cell Genesys, Inc. (Nasdaq: CEGE) today reported follow up clinical data from an ongoing Phase 2 trial of GVAX® vaccine for 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® vaccine for leukemia. The ongoing findings of this trial indicate that vaccine therapy is generally well tolerated and may reduce residual leukemic cells that persist after chemotherapy, as indicated by decreased levels of WT-1, a leukemia-associated genetic marker, which is detectable in over 95 percent of patients with active AML.

In addition, there was an observed correlation between relapse-free survival, decreased WT-1 and the vaccine-associated immune response. These follow-up trial results were reported at the American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, FL, by Dr. Ivan Borrello from Johns Hopkins University, Baltimore, MD (ASCO Abstract #6539).
The Phase 2 trial was conducted at four leukemia bone marrow transplant centers in the United States and enrolled 54 patients. To date, 28 patients have initiated GVAX® vaccination after achieving a complete response to chemotherapy and thus far 21 of these patients have completed the stem cell transplantation and initiated a series of post-transplant vaccinations. The majority of patients had detectable WT-1 levels in their blood following chemotherapy, indicating persistent leukemic cells. There were post-vaccination declines in WT-1 in 11 of 16 patients (69%) in the blood and in 12 of 20 (60%) in the bone marrow after just a single pre-transplant vaccination.

In addition, two-year relapse-free survival was greater in the 11 patients who showed a decrease in WT-1 in the blood following the single pre-transplant vaccination compared to those who did not (73% vs. 0%, log-rank p=0.03) and was also greater in the 19 patients who achieved an undetectable level of WT-1 in the blood following stem cell transplantation and further vaccination compared to the six patients who did not (89% vs. 17%, log-rank p=0.002). Finally, all six patients who mounted a vaccine-associated immune response, as measured by induction of a delayed-type hypersensitivity reaction to their own leukemic cells, have remained in complete remission from 16 to 29 months post transplant and all six of these patients have had a vaccine-associated WT-1 decline or undetectable levels at the time of vaccination. To date, there have been no serious side effects considered related to the vaccine therapy.

"We are encouraged by the results of our ongoing Phase 2 study of GVAX® vaccine in acute leukemia, particularly the observed correlation between vaccine-associated immune response, WT-1 response and relapse-free survival," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "We believe that GVAX® vaccine for leukemia represents a potential new treatment option for acute leukemia that may be particularly important to consider for elderly patients and patients for whom bone marrow transplantation is not readily available or indicated."

The form of GVAX® vaccine used in this leukemia clinical trial is a non patient-specific GVAX® product manufactured at Cell Genesys that is mixed at the treatment center with the patient's irradiated tumor cells that were collected prior to chemotherapy. Cell Genesys believes that this product could potentially be developed as an off-the-shelf pharmaceutical for use in multiple types of hematologic malignancies. Future manufacturing of the product would be expected to occur at the company's plant in Hayward, California, which has Phase 3 and potential market launch production capabilities.

Clinical trials of GVAX® cancer vaccines are under way for multiple types of cancer including prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Cell Genesys' GVAX® cancer vaccines are whole-cell vaccines which are designed to stimulate an immune response against the patient's tumor. The vaccines are comprised of tumor cells that have been irradiated and genetically modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is pursuing two clinical-stage cancer product platformsGVAX® cancer vaccines and oncolytic virus therapies. Clinical trials of GVAX® cancer vaccines include an ongoing Phase 3 trial of GVAX® vaccine for prostate cancer as well as trials of GVAX® vaccines for lung cancer, pancreatic cancer, leukemia and myeloma. Clinical programs of oncolytic virus therapies include CG7870 for prostate cancer and CG0070 for bladder cancer. Cell Genesys continues to hold equity interests in its two former subsidiaries Abgenix, Inc., an antibody products company and Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at www.cellgenesys.com.

Statements made herein about the company and its subsidiaries, 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, 2004 dated March 14, 2005 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.

Cell Genesys Reports Second Quarter 2005 Financial Results

SOUTH SAN FRANCISCO, Calif., July 25 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) reported a net loss of $27.4 million, or $0.60 per share, for the quarter ended June 30, 2005. This compares with a net loss of $26.0 million, or $0.58 per share, for the quarter ended June 30, 2004. The slight increase in net loss quarter to quarter is due primarily to the absence of gains from the sale of marketable securities. Cell Genesys ended the quarter with approximately $120.6 million in cash, cash equivalents and short-term investments, and in addition, held approximately 6.6 million shares of its former subsidiary, Abgenix, Inc., which as of June 30, 2005 had a market value of approximately $56.8 million.

The company's research and development costs for the quarter were $23.2 million, compared with $24.1 million for the second quarter of 2004. The decrease in research and development costs is due primarily to the absence of consolidated expenses from Ceregene, Inc., the company's former subsidiary, whose expenses were incurred in 2004 prior to the closing of Ceregene's Series B equity financing. General and administrative expenses decreased to $3.9 million in the second quarter of 2005 from $5.1 million in the second quarter of 2004 due to the accrual of certain facility-related costs in 2004.

"We are pleased with our recent business progress particularly with respect to the Phase 3 clinical trials for our lead product development program, GVAX® vaccine for prostate cancer," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "During the second quarter, we reported encouraging median survival data from our second Phase 2 clinical trial in advanced prostate cancer at this year's American Society of Clinical Oncology (ASCO) meeting and initiated our second Phase 3 clinical trial. We have the resources we need to advance our product development programs and a seasoned and accomplished executive team ready to lead our business forward."

Second Quarter 2005 and Other Recent Highlights:

-- Reported additional promising results at the ASCO Meeting from a second Phase 2 trial of GVAX® vaccine for prostate cancer in patients with metastatic hormone-refractory prostate cancer. The results for the 22 patients who received the highest dose -- a dose comparable to that employed in the company's ongoing Phase 3 program -- indicate that the median survival has not been reached and the final median survival will be no less than 24.1 months based on the current median follow-up time for these patients. Previously reported findings from the company's first Phase 2 trial of GVAX® vaccine for prostate cancer indicated an overall median survival of 26.2 months. The median survival results from both Phase 2 trials compare favorably to the recently reported median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Taxotere® plus prednisone, the current standard of care.

-- Initiated a second multicenter Phase 3 clinical trial of GVAX® vaccine for prostate cancer in patients with metastatic hormone-refractory prostate cancer. The VITAL-2 trial will compare GVAX® vaccine for prostate cancer plus Taxotere® (docetaxel) chemotherapy to Taxotere® plus prednisone with respect to survival benefit and is expected to enroll approximately 600 patients at approximately 100 medical centers across North America and Europe. In May 2005, Cell Genesys received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for this trial, which provided FDA confirmation that the trial design would adequately support a product registration application. The company's first Phase 3 trial, VITAL-1, is also being conducted under an SPA.

-- Reported encouraging follow-up clinical data at the ASCO Meeting from an ongoing Phase 2 trial of GVAX® vaccine for acute myelogenous leukemia (AML). The ongoing findings of this trial indicate that vaccine therapy is generally well tolerated and may reduce residual leukemic cells that persist after chemotherapy, as indicated by decreased levels of WT-1, a leukemia- associated genetic marker which is detectable in over 95 percent of patients with active AML. In addition, there was an observed correlation between two- year relapse-free survival, decreased WT-1 and the vaccine-associated immune response.

-- Announced that Sharon E. Tetlow has joined the company as senior vice president and chief financial officer. Ms. Tetlow, who was a venture partner at Apax Partners, a private equity firm, brings over 18 years of financial management experience in the life science industry, including over five years as chief financial officer for diaDexus, a pharmacogenomics company.

-- Announced a strategic restructuring to focus resources on the company's most advanced and most promising product development programs. Based on the encouraging data reported at this year's ASCO Meeting, Cell Genesys intends to deploy the majority of its resources going forward to advance GVAX® vaccine for prostate cancer currently in Phase 3 development, as well as GVAX® vaccine for leukemia and GVAX® vaccine for pancreatic cancer, both of which are in Phase 2 development. In the oncolytic virus therapy program, the company will focus on CG0070, which is in a Phase 1 trial in recurrent bladder cancer, and CG5757, which is in preclinical development, both of which can potentially target multiple types of cancer.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX® cancer vaccines and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX® vaccine for prostate cancer, Phase 2 trials of GVAX® vaccines for leukemia and pancreatic cancer, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer and potentially other types of cancer. Cell Genesys continues to hold equity interests in its two former subsidiaries -- Abgenix, Inc., an antibody products company, and 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 www.cellgenesys.com.

Cell Genesys will host its quarterly conference call to discuss events that occurred during the second quarter of 2005 at 8:30 a.m. PDT on Tuesday, July 26, 2005. Investors may listen to the webcast of the conference call live on Cell Genesys' website. A replay of the webcast will be available for at least 48 hours following the call. Alternatively, investors may listen to a replay of the call by dialing 800-475-6701 from locations in the U.S. and 320-365-3844 from outside the U.S. The call-in replay will be available for 48 hours following the call. Please refer to access number 787711.

Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, financial results, timing and results 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 funding. 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, 2004 filed on March 14, 2005 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

Site Map | Acute Myelogenous Leukemia