Hospital & Healthcare Management/ Healthcare Research Inside/ Oct 27th 2010 :- Prostate Oncology Specialists, Inc. of Marina del Rey is among the first sites in the nation to treat advanced prostate cancer patients with PROVENGE® (sipuleucel-T), the first in a new therapeutic class known as autologous cellular immunotherapies. PROVENGE was approved by the U.S. Food and Drug Administration (FDA) for the treatment of men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer and is made by Dendreon Corporation.
– Dr. Mark Scholz to Support PROVENGE as Breakthrough Treatment for Advanced Prostate Cancer at Upcoming MEDCAC –
"PROVENGE is a scientific breakthrough that paves the way for similar personalized treatments in other cancer types," said Dr. Mark Scholz, Medical Director of Prostate Oncology Specialists and co-founder of the Prostate Cancer Research Institute. "I’m pleased to have a new option to present to my patients and to be a part of the first physician-based facility in the area treating patients with this important new FDA approved therapy."
Prostate Oncology Specialists have treated over 30 patients with PROVENGE to date, and anticipates providing the therapy to many more men with metastatic castrate resistant prostate cancer as supply of the drug increases over the next six months.
"I was excited about using PROVENGE because it allowed me to use my own cells to help fight cancer," said PROVENGE patient Frank La Barba of Long Beach, CA. "My side-effects were mild and following my treatment, I was able to get back to doing the activities I did before receiving therapy, such as traveling and photography."
PROVENGE is an autologous (made from a patient’s own immune cells) cellular immunotherapy designed to stimulate a patient’s immune system to identify and target prostate cancer cells. Each dose is manufactured specifically for each patient using his immune cells.
The Centers for Medicare and Medicaid Services are currently undergoing a National Coverage Analysis (NCA) regarding autologous cellular immunotherapy treatment of metastatic prostate cancer. As part of the NCA process, Dr. Scholz will provide an expert opinion on PROVENGE data at the November 17th Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting in Baltimore, MD.
In addition, Dr. Scholz will be giving a presentation on the latest developments in treating advanced prostate cancer, including new immunological approaches such as PROVENGE and effective chemotherapy combinations, at an UsTOO educational session in Fullerton, CA on Thursday, October 28th beginning at 5 p.m. PT. For press attendance credentials or information on location for patients, please contact Lew Pfeffer at (626) 333-6034.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
The most common adverse events (incidence >15%) reported in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache.
Please see full Prescribing Information for PROVENGE at www.provenge.com.
About Prostate Cancer
According to the American Cancer Society, prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than two million men in the United States have prostate cancer, with an estimated 217,730 new cases and approximately 32,050 men expected to die from the disease in 2010.
Individuals interested in learning whether PROVENGE is an appropriate treatment option should contact Jennifer Leung at (310) 827-7707, extension 32 or Dendreon On-Call at (877) 336-3736. For full Prescribing Information, please visit www.PROVENGE.com.
About Prostate Oncology Specialists, Inc.
Established in 1995, Prostate Oncology Specialists has earned national acclaim for its comprehensive approach to prostate cancer prevention and management. Under the direction of Medical Director, Mark Scholz, M.D., Prostate Oncology Specialists employs a highly-skilled team of physicians trained in oncology, hematology and internal medicine. Prostate Oncology Specialists are not wedded to any single therapy for prostate cancer, but rather advocate the exploration of treatment options that are customized and tailored to the unique needs of each individual patient. Prostate Oncology Specialists’ ongoing mission is to uncover new medical breakthroughs in the treatment and management of prostate cancer.
About Prostate Cancer Research Institute
PCRI is a 501(c)(3) not-for-profit education and research organization founded in 1996 by Mark Scholz, M.D. and Stephen Strum, M.D.. The PCRI educates patients and their families about prostate cancer. This includes new advances in diagnosis, staging, treatments and available resources. PCRI believes that a patient who understands his disease and treatment is empowered to communicate more effectively with his physicians and obtain a better outcome. PCRI intends to use all available communication tools to accomplish this most important objective.
SOURCE Prostate Oncology Specialists, Inc.