SEATTLE, April 13, 2009 -Dendreon Corporation (Nasdaq: DNDN) will host a conference call tomorrow, Tuesday, April 14, 2009, at 9:00 AM ET (6:00 AM PT) to review the outcome of the FINAL analysis of its IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE® (sipuleucel-T), the Company’s investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

Those interested may access the call with the following information:

Time:         9:00 AM ET/6:00 AM PT

Date:          April 14, 2009

Dial-in:        1-877-419-6594 (domestic) or +1-719-325-4855 (international)

Webcast:       www.dendreon.com (homepage and investor relations section)

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 888-203-1112 or 719-457-0820 for international callers; the conference ID number is 8182435. The replay will be available from 12:00 pm ET on April 14, 2009 until midnight ET on April 16, 2009.  In addition the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.

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.

Data presented today from an ongoing study designed to explore the biologic and clinical activity of cancer immunotherapy sipuleucel-T, or Provenge, in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic disease are not all that impressive. The study showed that sipuleucel-T did not significantly delay the time it took for a patient’s PSA to reach a value of 3 ng/ml, the primary endpoint of the study, but it did show a prolongation in prostate-specific antigen doubling time (PSADT). An “early trend” toward slowing the time to metastatic disease for patients who received sipuleucel-T compared with those who received placebo “did not reach statistical significance.”

Read the full story

Jan Manarite of Raise a Voice Campaign writes:

Prostate cancer patients have been watching for the prostate cancer/Provenge story on ABC World News with Charles Gibson. I just got a call from Dr Moyad that ABC called the prostate cancer patient who was interviewed for that story, and informed him that it would air Monday night, June 4th. This appears to be a commitment. Did ABC wait for our June 4th DC rally?

A company in Hanover, Germany, Vakzine Projekt Management, reports positive clinical trial results with their therapeutic prostate cancer vaccine VPM4001. The results will be presented at the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago, USA.

A clinical phase I/II study with 30 patients completed in 2006 showed that 73% of patients suffering from advanced, hormone-resistant prostate carcinoma responded positively to the VPM4001 therapy. The primary study parameter, the PSA doubling time, was increased from 63 days to 114 days on average. This promising result has a high statistical significance (p=0.0035), the company says. PSA doubling time is a surrogate parameter well correlated to survival: higher PSA doubling times mean higher probabilities to survive a five year period. In this trial, the median survival time came to 981 days.

Dendreon announced today that the FDA will accept “either a positive interim or final analysis of survival” from its ongoing Phase III randomized clinical trial of Provenge immunotherapy for androgen independent prostate cancer.

In a press release, the company said it “has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to supplement the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.”

Jim Kiefert, chair of the executive committee of US Too International prostate cancer support group, interviewed yesterday at the American Urological Association (AUA)’s annual meeting by CNBC’s pharmaceuticals reporter Mike Huckman, said some members of his support group wept when they heard FDA had delayed approval of Dendreon’s vaccine for advanced prostate cancer, Provenge. The interview with Kiefert is part of the video at this CNBC link. Meanwhile advocates are signing a petition and plan to demonstrate in Washington D.C. and hope to meet with the head of the FDA.