((yet another large opportunity to significantly expand the size of the Provenge market))
http://www.prostate.net/2012/prostate-cancer/provenge-treatment-cancer/
Does Provenge Work Better as a Combination Treatment
December 6, 2012 By Deborah Mitchell
For now, the only available immunotherapy drug for prostate cancer, Provenge (sipuleucel-T), is typically prescribed alone for men who have advanced prostate cancer that meets certain criteria. However, new Provenge trials, both in animals and an upcoming trial in humans, explore combination treatment involving Provenge and other cancer drugs.
What is Provenge?
Provenge is a unique prostate cancer treatment option for men who have metastatic prostate cancer and no symptoms or cancer pain that does not require treatment with narcotics. Other criteria for taking Provenge include having tried and failed on hormone therapy, having prostate cancer that has spread to the bones or lymph nodes (but not to the brain, liver, or lungs), and not having had chemotherapy within the past three months.
Unlike other drugs for metastatic prostate cancer, Provenge supports the immune system rather than takes actions that compromise it. Each Provenge dose is also made individually from cells collected from patients, and only three doses are needed over a 4 to 5 week period. Other drugs for metastatic prostate cancer must be taken for at least eight months or longer.
The New Provenge Trials
At Georgia Health Sciences University Cancer Center, a research team has tested a combination of Provenge and two other anticancer drugs, CT-011 and cyclophosphamide, in animals. So far, results of these studies, under the guidance of GHSU Cancer Center Director Samir N. Khleif, have found that combining Provenge with the two cancer drugs resulted in a significant increase in overall survival. More than half of the mice in the studies also achieved complete regression of their tumors.
When used alone, Provenge has been able to extend survival in some men by nearly 20 percent (an average of 4.1 months longer than men who took placebo). Khleif and his team, in collaboration with Dendreon Corporation, the makers of Provenge, are now planning a human study that will enroll up to 63 men and will explore the impact of the combination of Provenge, CT-011, and cyclophosphamide. The trial is scheduled to end in 2017.
Cyclophosphamide is typically used along with other cancer-fighting drugs for treatment of leukemias, lymphomas, breast cancer, ovarian cancer, and multiple myeloma. Side effects associated with cyclophosphamide include nausea, vomiting, mouth sores, abdominal pain, diarrhea, hair loss, rash, skin color changes, and sterility. Some people develop secondary cancers as well.
CT-011 is an experimental drug that affects immune response and inhibits the growth of tumors and the spread of cancer. It is currently being tested in several clinical trials, including those for lymphoma and pancreatic cancer.
The new clinical trial combining Provenge with CT-011 and cyclophosphamide will provide researchers with additional information on how to best extend and improve the lives of men who have metastatic prostate cancer. Prior to these trials, neither CT-011 nor cyclophosphamide have been used in the treatment of prostate cancer.
http://www.prostate.net/2012/prostate-cancer/provenge-treatment-cancer/
Does Provenge Work Better as a Combination Treatment
December 6, 2012 By Deborah Mitchell
For now, the only available immunotherapy drug for prostate cancer, Provenge (sipuleucel-T), is typically prescribed alone for men who have advanced prostate cancer that meets certain criteria. However, new Provenge trials, both in animals and an upcoming trial in humans, explore combination treatment involving Provenge and other cancer drugs.
What is Provenge?
Provenge is a unique prostate cancer treatment option for men who have metastatic prostate cancer and no symptoms or cancer pain that does not require treatment with narcotics. Other criteria for taking Provenge include having tried and failed on hormone therapy, having prostate cancer that has spread to the bones or lymph nodes (but not to the brain, liver, or lungs), and not having had chemotherapy within the past three months.
Unlike other drugs for metastatic prostate cancer, Provenge supports the immune system rather than takes actions that compromise it. Each Provenge dose is also made individually from cells collected from patients, and only three doses are needed over a 4 to 5 week period. Other drugs for metastatic prostate cancer must be taken for at least eight months or longer.
The New Provenge Trials
At Georgia Health Sciences University Cancer Center, a research team has tested a combination of Provenge and two other anticancer drugs, CT-011 and cyclophosphamide, in animals. So far, results of these studies, under the guidance of GHSU Cancer Center Director Samir N. Khleif, have found that combining Provenge with the two cancer drugs resulted in a significant increase in overall survival. More than half of the mice in the studies also achieved complete regression of their tumors.
When used alone, Provenge has been able to extend survival in some men by nearly 20 percent (an average of 4.1 months longer than men who took placebo). Khleif and his team, in collaboration with Dendreon Corporation, the makers of Provenge, are now planning a human study that will enroll up to 63 men and will explore the impact of the combination of Provenge, CT-011, and cyclophosphamide. The trial is scheduled to end in 2017.
Cyclophosphamide is typically used along with other cancer-fighting drugs for treatment of leukemias, lymphomas, breast cancer, ovarian cancer, and multiple myeloma. Side effects associated with cyclophosphamide include nausea, vomiting, mouth sores, abdominal pain, diarrhea, hair loss, rash, skin color changes, and sterility. Some people develop secondary cancers as well.
CT-011 is an experimental drug that affects immune response and inhibits the growth of tumors and the spread of cancer. It is currently being tested in several clinical trials, including those for lymphoma and pancreatic cancer.
The new clinical trial combining Provenge with CT-011 and cyclophosphamide will provide researchers with additional information on how to best extend and improve the lives of men who have metastatic prostate cancer. Prior to these trials, neither CT-011 nor cyclophosphamide have been used in the treatment of prostate cancer.