Latest Cell Therapy Approval by FDA. Dendreon's Provenge.

It has been a long-time coming. It has been hyped and scoffed, bet against and hoped for, but now none of that matters. It's here. Dendreon has brought Provenge to market. Here, in the word's of the FDA...


FDA NEWS RELEASE

For Immediate Release: April 29, 2010

FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

Stem cells for a Webby!

I know I haven't been a very good blogger for quite some time but I wanted to pass on a letter I just received from my friend James Price as a Charter member of the Canadian Stem Cell Foundation. They're going for a Webby award. You don't have to be Canadian to support their cause - you just have to:

• believe in the power of interactive, online network-based activism,
  
• support the potential of stem cells to change people's lives, and
• wanna have a little fun raising awareness for our otherwise-sometimes-stodgy-science!

Go vote - it's good for you and the world! (WARNING: you might find out some things about some pretty cool stuff nominated in the other categories while you're there).

Dear Lee,

I'd like to thank everyone who has voted and helped spread the word about the Webby Awards nomination. We think a big part of the Foundation's success, and especially this nomination, is due to your enthusiasm, creativity and support. That support has taken us a long way. Right now, we're in the lead for Best Activism Website. But our lead is narrow, only 3%, so we need you to pull out all the stops. There are only two days left to vote, so let's make sure it's a win for stem cells! Why Activism? A large part of what makes our website and social media pages work is the Charter community. All the material we create - the Stem Cell Charter, "Rock Star Scientists" video and all the posts on our social media pages - are designed to give the stem cell movement a voice - your voice. You are the most important part of getting the word out about stem cell science and helping people see the amazing potential of the field. Voting and encouraging others to vote is a perfect way to do this. Tweet, post, blog, email and shout your support from the rooftops. Let's show the world how important we think stem cell science is. How to vote Step 1: Click HERE and fill in your email address and a password. Step 2: You will receive an email from the Webby Awards - click the link to activate your account. Step 3: Go HERE TO VOTE and choose RENEW THE WORLD. Voting closes at midnight on April 29th. We have two days left!

Thanks for your support, James Price President & CEO