Reuters and WAll Street Journal report today that Dendreon plans to seek US FDA approval for Provenge prostate cancer vaccine in November. Dendreon “expects regulators to act on the application by the middle of next year, the company said on Thursday.”

To start from an updated report in the Wall Street Journal, which adds this information to Reuters’ coverage of Dendreon ’s share prices today. The points are excerpted and reordered:

“These results confirm the clinical value of Provenge to prolong survival in patients with advanced prostate cancer,” said Dr. Philip Kantoff, head of the prostate cancer program and chief of the division of solid tumor oncology at the Dana-Farber Cancer Institute and Harvard Medical School, and a principal investigator of the Provenge study, in a statement.

“We’ve been waiting a long time for a drug that is well tolerated and that gives men with advanced prostate cancer another option,” said Christopher Amling, chief of urology at Oregon Health & Science University, Portland, Ore., who wasn’t involved with the study.

– Extended Median Survival by 4.1 Months and Increased 3-Year Survival by 38 Percent Compared to Placebo –
– First Active Cellular Immunotherapy for Cancer to Prolong Survival –
– Company to Host Webcast at 5:30 pm ET –

CHICAGO and SEATTLE, April 28, 2009 – Dendreon Corporation (NASDAQ: DNDN) today announced that its pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of significantly improving overall survival compared to placebo. The data were presented at the American Urological Association (AUA) Annual Meeting.

The intent-to-treat analysis demonstrated that:

* PROVENGE extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months);
* PROVENGE improved 3-year survival by 38% compared to placebo (31.7% versus 23.0%);
* The IMPACT study achieved a p-value of 0.032, successfully exceeding the pre-specified level of statistical significance defined by the study’s design (p-value less than 0.043), and PROVENGE reduced the risk of death by 22.5% compared to placebo (HR=0.775); and
* PROVENGE exhibited a favorable safety profile consistent with prior trials.

Hyam Levitsky

A four part interview with  Hy Levitsky M.D., professor of oncology and tumor immunology at Johns Hopkins Medical School and co-inventor GVAX anti-cancer vaccine, is posted on Dendreon Investor Village website.

Interview conducted by rufustoehee, a dentist and Dendreon investor, published 4/22/2009.

By way of introduction, Dr Levitsky’s bio is posted alphabetically downpage among those of other speakers at Cancer Immunology & Immunotherapy 2008: From Discovery to Development to Drug.

EXCERPTS FROM INTERVIEW

Conversation with Dr. Levitsky Part 1
“. . . . how this impacts on the field of tumor immunology, I feel it will very much depend on the nature of the data they present, assuming for the sake of discussion, that this is an unequivocal and unambiguous win, then I think it will have a very significant impact. Number one, I think that unless there are aspects to this that have not been made public, I think the FDA would in this instance need to move it forward in the approval process and I think that how it ultimately gets integrated into clinical practice will be a fascinating thing to watch.

“. . . . It is important to acknowledge that tumor response is a surrogate endpoint. It is a surrogate endpoint for perhaps 2 other endpoints that might be more meaningful. One is overall survival which is the gold standard and the other perhaps is the quality of life. No one can argue that those two things have sort of the paramount importance where as to an objective 50% or greater reduction in the mean diameter of all measurable tumor masses is an interesting yard stick, but it is only a yard stick.”

A Dendreon Inc., director, Gerardo Canet, sold over 200,000 stock options in the company on April 14. According to a filing with the SEC (Securities and Exchange Commission), the sale was made “pursuant to a Rule 10b5-1 trading plan.” Such trading plans are set up to defend company insiders from allegations of trading on insider information.

At 9 A:M ET on April 14 Dendreon’s CEO Mitchell Gold told investor analysts that Dendreon’s Provenge prostate cancer immunotherapy vaccine significantly prolongs survival in men with advanced metastatic prostate cancer. The results are “robust” and “unambiguous,” Gold stated.

“The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer,” the company stated in a press release April 14.

Mr. Canet’s SEC Form 4 filing was pointed out today by a member of the Dendreon message board at Investor Village. Members discussed whether Mr. Canet may have had a GTC or “Good ‘Til Canceled” order. This is “An order to buy or sell a security at a set price that is active until the investor decides to cancel it or the trade is executed. If an order does not have a good-’til-canceled instruction then the order will expire at the end of the trading day the order was placed.”

The SEC form in question states “The sales reported on this Form 4 were effected pursuant to a Rule 10b5-1 trading plan adopted by the reporting person.”

Dendreon’s prostate cancer vaccine significantly prolonged the overall survival among 500 men with advanced, metastic  prostate cancer  compared to a placebo, the company said Tuesday.

Results were “robust” and “unambiguous,” a spokesman said during today’s (Tues April 14) company broadcast conference call with biotech investment analysts.

“The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer,” Dendreon Chief Executive Mitchell Gold said in a statement.

“Survival is the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint of the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE may prolong survival,” Dendreon CEO Mitch Gold said.

The Seattle-based drugmaker said the phase III study of Provenge, known as IMPACT, met its primary endpoint with statistical significance. Details of the study are being withheld so that they can be presented at the American Urological Association’s Annual Meeting in Chicago on April 28.

In submitting Provenge vaccine for the treatment of advanced prostate cancer for fast-tracked FDA approval despite aborting one clinical trial due to failure to meet the primary endpoint, Dendreon relied on meta-analysis of combined data from two parts of a phase III study, D9901. In fact, after the trials failed to meet their primary endpoint, time to progression, they were analysed twice over. Dr. Eric Small presented meta-analyses of impact on overall survival and prostate cancer specific survival and Dr. Daniel Petrylak presented a further analysis or suvival focused on a subset of patients who, when they progressed on Provenge, took Taxotere.

A link to a 5 hour video recording of the FDA Advisory Committee hearing held March 29 on sipuleucel-T (Provenge) for advanced, androgen independent prostate cancer. The video does not include the vote.

A full written transcript in .pdf including the voting is online at FDA, click here.

A crowd of about 70 people led by prostate cancer advocates marched and rallied in Washington, D.C. on June 4 to call on the FDA to Approve Provenge Now.

Thomas Farrington of Prostate Health Education Network addressed the group.

Raise a Voice organizer Jan Manarite introduced speakers including Tom Farrington and Dr. Mark Moyad.

The petition campaign was organized by malecare.com.

Visit Joel Nowak’s advancedprostatecancer.net blog,
Provenge Advocacy Hits the News

Organizer Jan Manarite receives a hug

from her son, who carried the message

"Help My Dad Live"

On June 5, campaigners met with FDA director Andrew von Eschenbach.

View ABC-TV video here. See photos of the rally (by brad.wick) and video of Mark Moyad’s speech.

Oncologist Dr. Howard I. Scher has received a death threat for opposing immediate FDA approval of Dendreon’s Provenge therapeutic vaccine for prostate cancer. Another oncologist who opposes approval of Provenge without completion of an ongoing clinical trial, Dr. Maha Hussain, has received unspecified threats.