Dendreon Jumps on New Cancer Vaccine Report

A new study published in the peer reviewed publication Clinical Cancer Research found that human trials of the new class of cancer vaccines, which includes Dendreon's (DNDN) Provenge for prostate cancer, have been aiming for a primary endpoint that is irrelevant.

Typically, the success of cancer treatments in clinical trials is measured by the reduction in the size of tumors. This was apparently the reason why the FDA refused to give Provenge final approval, citing that the average size in prostate tumors did not significantly shrink.

The new study however, points out that most cancer vaccine trials have increased the survival rate of patients, regardless of the change in size of tumors during the study period. Cancer vaccines need more time to work in order to induce changes in the immune system of patients to fight off the cancer.

As expected, shares of Dendreon jumped more than 6% on Tuesday on the study findings, and deservingly so.

Imagine calling a clinical study a failure because the tumor size did not significantly decrease, yet the average survival rate of patients increased! Is it not the survival of patients the real aim of medical treatment? Provenge deserves a second hard look by the FDA, and Dendreon stock still has a lot of room to the upside; deservingly so.

Comments

[Jim Glazen:]

This is old news and it's incredible that the stock would surge on this. It just goes to show how much stupid money is still chasing after hopes and dreams.

lmao!

2007 Jul 04 01:21 AM

[Dan Gseekin...:]

Dr. Sclom doesn't seem to have COI with big pharmas and/or with other competing biotechs and/or with Venture Capital Funds that invest in biotechs, it is likely that he doesn't advise to hedge-funds and that he does not participate in FDA Panels on behalf of Pazdur after ommitting material information in his FDA-waiver request. Hence, his studies do not carry any scientific merit. Moreover, Schlom has to understand that tumor shrinkage is the gold standard for terminal diseases. Survival, pain and side effects are nothing but surrogate markers.

What a waste of time to conduct scientific studies or to participate in 2-day FDA-NIH-NCI immunotherapy symposiums a couple of weeks prior to AdComs ... the FDA and the pharmaceutical world are all about "HUMAN NATURE"


(or, in other word - CORRUPTION)

2007 Jul 04 06:01 AM

[Wolfgang Paul:]

Dendreon investors believe that Jeffrey Schlom's paper (published 7/1/2007 in the journal Clinical Cancer Research), that provides an argument for a change in the required design of clinical trials for cancer vaccines FDA and how conventional therapies for cancer can be greatly augmented by first administering a cancer vaccine (like Dendreon's Provenge immunotherapy for Prostate cancer), could add pressure to change the FDA requirements for approving cancer vaccines from the classic metric of tumor response to a new metric of patient survival in clinical trials. If the FDA requirements can be ammended, the approval of Provenge could be much sooner than previously thought.

2007 Jul 04 04:11 AM

[Jim Glazen:]

Dendreon's trials failed to statistically slow tumor progression but also were not designed to measure survival as an endpoint. I fail to see how a change in FDA requirements for approving cancer vaccines would help Provenge gain approval sooner than thought.

Dendreon needs to complete the current trial which is not even fully enrolled yet.

Dendreon "investors" are about the dumbest of the dumb in my opinion. They ran the stock up to $11 per share on news that the FDA wanted Dendreon to complete the current trial only to watch the stock settle back down to $6.50.

In my opinion, Mitch Gold, CEO told you all you needed to know just days after the FDA panel. He dumped 200,000 shares at $13+. Anyone with half a brain should have followed him out the door and never look back.

I frankly believe that Provenge does add some benefit. It's definitely not a cure and might add 4 months of survival. $60,000 cancer treatments for 4 extra months of life is the reason our health care costs are skyrocketing. We need more research dollars devoted to prevention and healthy lifestyle habits.

2007 Jul 04 10:11 AM

[Wolfgang Paul:]

Regarding the assertion that Dr. Jeffrey Schlom's "studies do not carry any scientific merit,"

Dr. Schlom is the chief of the National Cancer Institute's Laboratory of Tumor Immunology and Biology, and a member of the National Cancer Institute Cancer Prevention Faculty, Gastrointestinal Malignancies Faculty, Genitourinary Malignancies Faculty, Immunology Faculty, Molecular Targets Faculty, and Vaccine Working Group. He and his researchers have literally written hundreds of peer reviewed papers on tumor immunology, mechanisms of tumor cell-immune cell interactions, and immune mechanisms. Perhaps you should inform the National Cancer Institute that Dr. Schlom's studies do not carry any scientific merit and apply for the job yourself.

ccr.cancer.gov/Labs/La...

2007 Jul 04 04:29 PM