other examples for immunotherapy

Advaxis, Inc ... the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, ...

Advaxis clinical trial program that include three (3) Phase II and one (1) Phase I in cervical cancer (2), cervical dysplasia (1) and head and neck cancer (1), respectively.

FDA Approves Provenge, the First Immunotherapy for Metastatic Prostate Cancer
Nick Mulcahy
April 29, 2010 — In a widely anticipated announcement, the US Food and Drug Administration (FDA) has approved an immunotherapy, sipuleucel-T (Provenge, Dendreon), for the treatment of asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer (mCRPC).
Often referred to as a vaccine, sipuleucel-T is an autologous active cellular immunotherapy, meaning that it is made from the patient's own white blood cells and stimulates a patient's immune system to respond against the cancer. The treatment needs to be manufactured individually for each patient.
"The availability of [sipuleucel-T] provides a new treatment option for men with advanced prostate cancer who currently have limited effective therapies available," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research, in a press statement.
Sipuleucel-T becomes the first product approved by the FDA in a new therapeutic class known as active cellular immunotherapies, according to Dendreon press materials.
To be approved by the FDA, investigators had to show that sipuleucel-T would extend survival in men with mCRPC.
In the pivotal phase 3 study, with a median follow-up of 36.5 months, men treated with sipuleucel-T (n = 341) had a median survival of 25.8 months, compared with men treated with placebo (n = 171), who had a median survival of 21.7 months
Thus, with the new therapy, there was a 4.1-month median survival advantage and a 24.1% reduction in the risk for death (hazard ratio, 0.759; P = .017), compared with placebo.
These latest data from the pivotal trial, known as IMPACT (Immunotherapy for Prostate Adenocarcinoma Treatment), were presented at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium in March.
Last year, after a presentation of very similar survival data on sipuleucel-T at the 2009 American Urological Association (AUA) annual meeting, one of the study investigators hailed the survival benefit.
http://www.medscape.com/viewarticle/702085

"This 4-month extension in survival is very, very significant," said David F. Penson, MD, MPH, at the AUA meeting. Dr. Penson is a professor of medicine at the University of Southern California Los Angeles.
"These patients have a life expectancy of about 2 years, so giving them 4 more months is pretty important. It gives them about 20% more life. And [sipuleucel-T] does it with minimal adverse events. So there is improved survival with good quality of life," he added.
According to the FDA press release, the most common adverse reactions reported with the new product are chills, fatigue, fever, back pain, nausea, joint ache, and headache. The majority of adverse reactions were mild or moderate. Serious adverse reactions, which were reported in approximately one quarter of the patients receiving sipuleucel-T, included some acute infusion reactions and stroke.
Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5% of patients in the sipuleucel-T group, compared with 2.6% of patients in the placebo control group
The approval of sipuleucel-T has been a long time coming.
Brantley Thrasher, MD, chair of the Department of Urology at the University of Kansas Medical Center in Kansas City, said that "this will cause a big splash."
"We don't have anything for patients with hormone-refractory disease, which is very aggressive. . . . Improved survival with T cell immunotherapy is really very significant," he said.


FDA News
Data Support PCa Vaccine's Mechanism of Action
Phase 3 trial data presented at the American Association of Cancer Research annual meeting support the mechanism of action of Provenge (sipuleucel-T), a novel investigative immunotherapy for advanced prostate cancer, according to a statement issued by Dendreon Corp., of Seattle, which is developing the treatment.
Designed to stimulate a T-cell response to prostate cancer cells, Provenge targets prostatic acid phosphatase (PAP), an antigen expressed in 95% of prostate cancer.
The data were from 237 patients who participated in the immune monitoring protocol of the IMPACT (Immunotherapy for Prostate Adenocarcinoma Treatment) trial. Provenge generated antigen-specific responses, including responses to PAP; these responses were not observed in placebo recipients. Provenge also triggered both cellular and humoral immune responses in vivo that were first observed six weeks after dosing; these responses persisted at 26 weeks. In addition, Provenge induced a T-cell response, suggesting the induction of immunologic memory.


Asbestos.com > Mesothelioma & Asbestos News

Mesothelioma Immunotherapy Making Headway in the Fight Against Mesothelioma Cancer
Thursday, May 20th, 2010
Malignant mesothelioma research is turning to novel treatment approaches such as immunotherapy to find a combination of therapies that may one day result in a cure for this aggressive cancer.
A rare cancer caused by asbestos exposure, malignant mesothelioma rarely responds to one mode of treatment. To combat the cancer medical professionals have come to learn that more than one mode of therapy is required, such as combining chemotherapy with surgery and radiation therapy. Usually the only patients who qualify for this aggressive treatment approach are the patients who are diagnosed in an early stage of cancer development.
Despite some success with extended mesothelioma life expectancy, a cure for mesothelioma has yet to be found. As a result, researchers are turning to novel treatments like immunotherapy to improve the multimodality approach with up and coming therapies.
According to mesothelioma researchers Dr. Sutapa Mukherjee and Dr. Bruce W. S. Robinson, authors of the chapter “Immunotherapy of Malignant Mesothelioma” in the book Mesothelioma, “Immunotherapy uses unique host defenses to initiate and effect [tumor] regression. This is different from radiation therapy and chemotherapy, which are directly cytotoxic to cancer cells and kill a fixed percentage of [tumor] cells rather than a fixed number of cancer cells. Interestingly, complete responses to several cycles of chemotherapy may not be possible unless there was an effective host immune response generated against the [tumor] when the [tumor] burden had been reduced to a level to allow the immune response to occur.”
Results from one of the more recent studies on mesothelioma immunotherapy were published in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine. The study investigated a potential vaccine that helps to combine a patient’s own dendritic cells (DCs) with an antigen from the patient’s specific mesothelioma tumor. “This is the first human study on DC-based immunotherapy in patients with mesothelioma,” says to Dr. Joachim G. Aerts, a researcher and pulmonary physician at Erasmus Medical Center in the Netherlands.
Other recently completed or active clinical trials on mesothelioma immunotherapy include “Cyclophosphamide Plus Vaccine Therapy in Treating Patients with Advanced Cancer” and “Safety and Immune Response to a Multi-Component Immune Based Therapy (MKC1106-PP) for Patients with Advanced Cancer.”
Additional information on mesothelioma and immunotherapy may be found through the Mesothelioma Center.


Local people with non-small cell lung cancer needed for immunotherapy trial
By James T. Mulder / The Post-Standard
May 13, 2010, 9:40PM
Syracuse, NY -- Syracuse area patients are being recruited to participate in the world’s largest lung cancer treatment trial.
Upstate Medical University and Hematology Oncology Associates of CNY are two of 400 centers in 33 countries participating in the study of a new approach to lung cancer treatment called immunotherapy, which teaches the body’s immune system to fight and destroy cancer cells.
The treatment was developed by GlaxoSmithKline. The trial will seek to determine if the treatment delays the recurrence of cancer in patients with non-small cell lung cancer after they have had surgery to remove their tumors.
The prognosis for lung cancer patients after surgery is not good. Only about 65 percent to 70 percent of patients diagnosed with stage 1 non-small cell lung cancer survive five years after surgery. The percentages are much lower for patients diagnosed with more advanced stages of cancer.
“What this is trying to do is improve on those statistics,” said Dr. Richard Cherny of Hematology-Oncology Associates, a private cancer practice headquartered in East Syracuse.
Scientists involved in the research found that there is a unique protein on the surface of cells in about 30 percent of non-small cell lung cancers. The treatment developed by GlaxoSmithKline is designed to seek out that protein and initiate an immune response to fight residual cancer cells, Cherny said.
The treatment is a very personalized therapy, said Dr. Leslie Kohman, a surgery professor at Upstate. “The more we learn about the characteristics of patients and tumors on a molecular basis, the more we can avoid treating patients who don’t need it or won’t benefit from it,” Kohman said. “Right now we give chemotherapy to a lot of patients who could not benefit because their tumor is not susceptible, but we don’t know that.”
The trial will be randomized. Two of every three people will get the treatment and one will get a placebo. It’s double-blinded, which means neither the investigator nor the patient will know what the patient gets. Participants will get five injections over 15 weeks.
Side effects can include skin reactions and flu-like illness, according to Cherny. “There have not been serious side effects we know of,” he said.
Lung cancer kills more people than any other type of cancer. There are about 1.2 million new cases diagnosed worldwide annually. Non-small cell cancer is the most common type. Smoking is the major cause of lung cancer.
Only about 5 percent of adults with cancer participate in clinical trials, according to Kohman. “If they have the opportunity to participate in a clinical trial for cancer or any other disease, they should strongly consider it,” Kohman said. “Not only might they get some individual benefit, but they certainly will benefit future patients with the knowledge gained from participating in such a study.”