Clinical Activity of Genasense in Patients with Refractory Myeloma Highlighted in Multiple Presentations at International Scientific Meeting
05/27/2003 08:02 ET
BERKELEY HEIGHTS, N.J., May 27, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated ( NASDAQ: GNTA) today announced results from several clinical presentations that featured Genasense(TM) (oblimersen sodium), the Company's lead anti-cancer agent, in combination with chemotherapy for the treatment of patients with multiple myeloma. The results were presented at the Ninth International Workshop on Multiple Myeloma, sponsored in part by the Multiple Myeloma Research Foundation, in Salamanca, Spain.
In preclinical studies the initiation of myeloma cell death by standard chemotherapy has been shown to be blocked by Bcl-2, the target of Genasense therapy. By inhibiting the Bcl-2 protein, which is expressed at very high levels in patients with myeloma, Genasense may overcome the inherent resistance of myeloma to such treatment. Genta is broadly exploring the use of Genasense as a means of amplifying the effectiveness of chemotherapy in patients with myeloma in several Phase 2 and Phase 3 trials.
In a trial sponsored by the U.S. National Cancer Institute (NCI), under a Cooperative Research and Development Agreement between the NCI and Genta for Genasense and the NCI and Celgene for thalidomide, Dr. Ashraf Z. Badros from the University of Maryland presented results from a Phase 1-2 study using escalating doses of Genasense and Thalomid(R); (thalidomide, Celgene), plus high-dose dexamethasone. To date, 17 patients have been enrolled into this ongoing trial. All patients had previously received dexamethasone, half had previously received thalidomide, and 15 of the 17 (88%) had progressed despite high-dose chemotherapy and stem-cell transplantation. Of 15 evaluable patients, 3 patients (20%) achieved a complete or near-complete response, and 5 patients (33%) achieved a partial response, for an overall major response rate of 53%. Four other patients (27%) achieved a minor response. Eleven patients remain on study and continue to receive treatment.
Updated results from a second clinical study were presented by Dr. Niels van de Donk and Dr. Henk Lokhorst from University Medical Center Utrecht, The Netherlands. In this trial, myeloma patients who were refractory to prior chemotherapy were treated with Genasense plus a standard drug combination known as "VAD" (vincristine, doxorubicin, and dexamethasone). Nine patients are currently evaluable, (8 had received prior dexamethasone, 5 had received prior thalidomide and 6 had a prior transplant). To date, 4 patients have achieved a partial response (44%).
Lastly, Dr. Asher Chanan-Khan from the Roswell Park Cancer Center in Buffalo presented a plenary lecture entitled "Bcl-2 antisense therapy in multiple myeloma", in which he reviewed preclinical and clinical data that underlie the development of Genasense in patients with myeloma and other lymphoid cancers.
"It is noteworthy that high-dose dexamethasone -- a core component of our current Phase 3 trial -- is also common to both of these clinical trials," observed Dr. Loretta M. Itri, Genta's Executive Vice-President for Clinical Development. "The new combination data with thalidomide also seem especially promising in view of that drug's emerging role in the treatment of patients with newly diagnosed disease. Genta is committed to examining Genasense as a means to improve overall outcome in patients with this devastating illness."
About Multiple Myeloma
Multiple myeloma is a cancer that arises in blood cells (called plasma cells) that normally reside in the bone marrow. Plasma cells normally produce antibodies that fight off infections. When cancer develops in plasma cells, these cells markedly increase in number, which can cause severe bone pain and fractures; however, their ability to produce antibodies is actually greatly reduced. Therefore, people with these conditions are highly susceptible to infections. Malignant plasma cells are known to contain a high amount of Bcl- 2 protein, which is targeted by Genasense. Further information about these diseases can be found at the website of the Multiple Myeloma Research Foundation: 206.204.218.38.
About Genasense
Genasense works by inhibiting the production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatments. Genasense is currently in multiple late-stage randomized clinical trials including malignant melanoma, multiple myeloma, chronic lymphocytic leukemia (CLL), and non-small cell lung cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two programs that center on oligonucleotides (DNA/RNA-based medicines) and small molecules. Genasense(TM) (oblimersen sodium), which is being developed in collaboration with Aventis, is the Company's lead compound from its oligonucleotide program and is currently undergoing late-stage, Phase 3 clinical testing. The leading drug in Genta's small molecule program is Ganite(TM) (gallium nitrate injection), which the Company intends to launch later this year for treatment of cancer-related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: genta.com. |
