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.

A team of urologists in Brussels estimate that a third of the men currently diagnosed with prostate cancer in their service could benefit from active surveillance, avoiding loss of quality of life. The Belgian doctors, led by Paul J Van Cangh, MD, are concerned that “widespread opportunistic PSA screening of prostate cancer has resulted in a large proportion of patients aggressively treated for low burden disease.” Reporting on the topic at this year’s annual meeting of the American Urological Association (AUA) in Anaheim California, May 19-24, they say: “Increased concern about overtreatment has led to the development of active surveillance protocols. Here we have reviewed pathological characteristics, disease free survival, and quality of life of patients treated by radical prostatectomy (RP) who might have been elected for active surveillance.”

Full story: Measuring Damage from “Over-Treatment” Of Indolent Prostate Cancer — Quality of Life Could Be Spared by Applying Selection Nomograms.

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

Charles (Chuck) Maack, a prostate cancer survivor and Program Director, for Wichita, Kansas Chapter Us TOO Intl., Inc., will be attending a meeting in Atlanta this September regarding “IMPaCT” (Innovative Minds in Prostate Cancer Today). Chuck is also spreading the word about the PCRI conference in Los Angeles from September 7-9. Chuck writes:

IMPaCT is a gathering of over 600 research scientists who have received Department of Defense funding for prostate cancer research in the past. It appears this gathering will be to brainstorm innovative ideas for future prostate cancer research.

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?

Washington DC walk & assembly

When: Monday, June 4th

Purpose:

To display our unified dissatisfaction with recent FDA Provenge ruling, and gain news coverage as the largest D.C. prostate cancer assembly ever held (350 or more). We are raising a voice for prostate cancer once again, and the unmet need for more treatment options for advanced PC patients. We are building on what we accomplished together at the March 29th FDA Provenge review meeting.

We ARE newsworthy! (ABC, NBC, CNBC, Seattle Times, and Wall St Journal so far)

We ARE a powerful voice and force!

We ARE a larger group of voting taxpayers than the government seems to realize.

We WANT better communication and representation!

How can an organization claim to be objective when they’ve totally lost sight of the object? We ARE the object.

Attire: Blue shirt, any type
Blue jeans, jean shorts, or jean skirt (or something comparable).
Those who have a military or law enforcement job, wear your uniform if you can.
Those in the medical field, wear your uniform if you like.
(we will have blue rain ponchos in case of inclement weather for $1 donation)
Wear comfortable shoes.
Bring water.

Signs: Inquire with Jan on content. There are strict regulations for signs, but signmakers are welcome. Again, you must inquire with Jan at (239) 395-0995 or [email protected]

Visual Ideas:
Bring men & women in uniform.
Bring a friend, family member.
We are working on having music.
We are working on trucks with blue ribbon, etc.
Motorcycles canNOT find a place to park, so not a workable idea.

This is being organized by Jan Manarite of PCRI, and Raise A Voice. Jan helped to organize and coordinate the success at the March 29th FDA Provenge review meeting. Our plan is to make this another memorable, meaningful event for men with prostate cancer.Washington DC walk & assembly

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.

From ASCO annual general meeting, 2007, comes this abstract of a study by A. Reichle, B. Walter, A. Berand, M. Vogelhuber, K. Bross, J. Wilke, W. Wieland, R. Andreesen, S. Rogenhofer.

Background: The present multi-centre phase II study was designed to support the hypothesis that networking agents binding to ubiquitous accessible targets in metastatic hormone-refractory prostate cancer (HRPC) may counteract neoplasia-specific aberrant cellular functions, thereby mediating objective response (primary endpoint).

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.”

Cougar Biotechnology’s once-daily oral drug CB7630 (abiraterone acetate), based on recently announced trial results, appears o have some efficacy at two stages of the standard treatment path for androgen independent prostate cancer — either before or after chemotherapy.

A UK Phase I/II trial of CB7630 reports positive signs among a small number of patients enrolled so far in a trial for AIPC men who have never taken chemotherapy but have taken LHRH analogues and multiple other hormonal therapies, including antiandrogens, diethylstilboestrol and dexamethasone. In addition, a Phase II trial ongoing at several US centers and in the UK indicates that CB7630 may benefit some patients who have used up Taxotere (docetaxel) chemotherapy.

CB7630 (abiraterone acetate) is reported to have “minimal toxicity” (as yet no maximum tolerated dose has been reached). Among the small numbers of patients treated so far, benefits include lowering of PSA’s, some tumor shrinkage, and some pain reduction. In one of the trials, out of “20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured
by the RECIST criteria) in 11 patients (55%), with 7 patients demonstrating ongoing stable disease and 3 patients experienced regressing bone disease.”

The company says CB7630 “has the potential to be used by both urologists who treat patients with second line hormonal therapies and by medical oncologists who treat patients in the second line chemotherapy setting…” To that end, the company chose to announce results at AACR, aiming the presentation toward oncologists, and again at AUA:

Cougar Biotechnology Announces Interim Phase II Results Confirm
Efficacy of CB7630 in Both Chemotherapy Naïve and Chemotherapy
Refractory Prostate Cancer Patients April 17 (posted May 31) 2007.

Cougar . . . Presentation of Positive CB7630 (abiraterone acetate)
Clinical Data at AUA Annual Meeting May 21 (posted May 31), 2007

For three UK and US trials ongoing see:
clinicaltrials.gov/ct/search?term=CB7630&submit=Search