Kim Stewart would liked to have spent Saturday morning behind the handlebars of his motorcycle. Instead, he pulled his orange and black cruiser into the parking lot at Park Ridge City Hall to have his blood drawn and his rectum examined as part of a free prostate cancer screening sponsored by the Chicago Sun-Times.

“I’m at the age where I know I need to take steps to [look] for things that regular doctors won’t catch,” said Stewart, 54, of Morton Grove. “The exam was messy, but it was worth it.”

Stewart was one of 3,775 Chicago area men who dropped trou last week for free prostate screenings from mobile clinics parked around the region.

The turnout was the largest in the four-year history of the Drive Against Prostate Cancer, according to officials at the National Prostate Cancer Coalition, a co-sponsor of the initiative.

Full story CANCER EXAMS | Sun-Times campaign sets turnout record
April 29, 2007 BY BEN GOLDBERGER Staff Reporter

Today’s New York Times reports that two groups of scientists, “one led by Allan Bradley and Martin Turner in England and the other by Klaus Rajewsky at Harvard Medical School,” have independently made major discoveries about the immune system.

“These findings demonstrate the importance of this level of control in the immune system and will lead immunologists to rethink how the immune system works,” said Dr Martin Turner, Head of the Laboratory of Lymphocyte Signalling and Development at the Babraham Institute.

According to today’s issue of the journal Science, Friday Apriil 27, the discoveries number not just 2 but 4:

In a flurry of papers, three of which appear on pages 575, 604, and 608 of this issue of Science, four independent groups have for the first time deleted mouse genes for microRNAs, RNA molecules that can modulate gene behavior, with profound effects.

(full story…)

Unique in Canada, offers right information at right time to men diagnosed with disease
ANDREA MACRAE
The Guardian

The day Norm Fotheringham got his diagnosis he knew only one thing about prostate cancer: that it was deadly.

“My brother was dying of prostate cancer. I had my operation in April and he died in June of that same year. I wouldn’t have had my prostate checked without him. So he basically saved my life.”

That was in 1998 in Ontario. Now Fotheringham helps prostate cancer patients on P.E.I. as chairman of the Prostate Cancer Support Group.

It’s his way of giving something back, he says.
Full story, The Guardian Charlottetown, PEI, Canada

When Provenge vaccine for prostate cancer is approved by the FDA, as most likely it will be on or by May 15, this decision to make this new therapy available immediately to any patient who can afford or whose insurance covers it — rather than to delay approval until the results are in from a larger clinical trial — will be due to Michael Milken. In Cora Daniels’ blockbuster article for Fortune Magazine (November 2004), The Man Who Changed Medicine, reprinted at Cptech.com, Milken said:

I believe the person who waits for 110% of the facts to be in and all the information is a person who is probably not alive — because it’s too late for him. A lot of businesspeople have been forced to make decisions without 100% or perfect information but based on what they know. I worked in a field where ten seconds was a long decision process. Either you’re buying the securities or you’re not. Either you’re selling them or you’re not. Now people said, ‘Well, gosh, that’s a short period of time,’ and I say, ‘No, it’s not.’ I’ve prepared my entire life to make that decision. I think getting off that inertia of making a decision qualifies well in building something.

(full story…)

Pages: 1 2

Dr. Maha Hussain (left) is calling for an open access program for Dendreon’s Provenge prostate cancer vaccine (Sipuleucel-T) pending completion of an ongoing, 500 man clinical trial, She made this suggestion March 29 during the FDA Advisory Committee hearing after voting “No” on the vaccine’s efficacy. She followed up with a letter to the FDA reiterating her “No” position and again calling for an open access program.

Dr. Hussain is the second oncologist among 4 members of the panel who voted “No” to the efficacy of the drug who has followed up with a letter to the FDA.
(full story…)

Dr. Maha Hussain, an oncologist who was one of 4 out of 17 members of the FDA Advisory Committee to vote against accepting against the company’s claim to efficacy for Provenge (Sipuleucel-T) prostate cancer vaccine, is calling for an expanded access program to empower patients who want and need it to receive the drug while an ongoing 500 man clinical trial of Provenge is completed.
(full story…)

A new blood test for detecting prostate cancer, ProstaMark® EPCA-2, is expected to enter large trials soon and may be available to the public in under 2 years. A study in the April issue of Urology presents evidence in support of EPCA-2 testing as a more accurate way to identify early stage and advanced cancer in the prostate. Full story

Ambrilia, a Montreal company, said today that results of a Phase I/II trial of PCK3145 in patients with metastatic prostate cancer show that the drug, a small molecule peptide, slows patients’ tumor doubling time..

Previously, detailed Phase I results were presented at ASCO and are online: Slovin, S., et al. Phase I trial results of PCK3145 in patients with castrate metastatic prostate cancer – the US experience. ASCO Prostate Cancer - San Francisco, California, U.S.A., February 2006.

Scientists have discovered that some Chinese people carry a gene variant that protects them against cancer. A variant of the same gene, caspase-8 (CASP8), was discovered earlier this year to afford some Western women protection from breast cancer. In US men, caspase-8 is involved in cell-signaling regulation by the androgen receptor and may play a role in prostate cancer.
(full story…)

A daily dose of adult-strength aspirin may modestly reduce cancer risk in populations with high rates of colorectal, prostate, and breast cancer if taken for at least five years.
(full story…)

Reviewing Proveng’s chances of FDA approval from the point of view of investors, Matthew Herper gives an overview useful for patients as well. Herper writes:

The FDA has a legal deadline of May 15 to make a decision–although it is possible to break or extend it. But buying the stock in front of this deadline is probably highly risky. There is a reasonable chance the FDA will decide to go against the panel vote and ask for more data. And the downside to the stock if the FDA does delay approval by asking Dendreon for more data is probably much bigger than any potential gain.

(full story…)

“It was a great shame,” a correspondent writes, “that the lead investigator for the first Provenge pivotal trial, Dr. Eric Small, had his flight cancelled by his airline so he was not able to join the panel in time. Dr. David Penson, however, has been an investigator on all three clinical trials for Provenge. During the public commentary section, he clearly articulated how his patients benefited. Dr. Penson came to the CTGT public commentary meeting of his own accord and did not discuss his testimony with the sponsor.”
(full story…)

Anemia drugs may be safer for cancer patients to take than recenty thought. This week Amgen released data showing that its anemia dug Aranesp (darbepoetin alfa) did not increase risk of death when used with platinum chemotherapy by patients with extensive small-cell lung cancer (SCLC), but nor did the anti-anemia drug improve patients’ survival.

This news may allay some fears arising from a Phase III study that found that in a group patients with active cancer who were not receiving chemotherapy or radiotherapy, the overall number of deaths was greater in those who received Aranesp than in those who did not.

An FDA panel is scheduled to review the safety of anemia drugs on May 10.
(full story…)

This is the text of Howard Scher M.D.’s letter to FDA about the March 29th advisory committee hearing on Dendreon’s vaccine Sipuleucel-T (Provenge):

I am writing to express concerns about the recent review of Sipuleucel-T at the FDA Advisory Meeting on March 29, 2007. These concerns are: a recommendation for approval based on data that fall short of the regulatory requirements; an inadequate statistical construct to determine definitive benefit; incomplete data on product safety; and what appear to be different criteria for approval by two Advisory Committees to the Agency.

(full story…)

To screen or not to screen for prostate cancer in men remains in question in Europe as two recent studies presented at the European Urology Association meeting last month reveal. In a session on screening, two urologists, Dr. Schroeder of Rotterdam and Dr. Pelzer of Innsbruck, presented data in support of contrasting positions.
(full story…)

Scientists have found evidence that the stress hormone epinephrine causes changes in prostate and breast cancer cells that may make them resistant to treatment. Learning how to cope well with stress could play a role in preventing and treating the disease.

“This data implies that emotional stress may contribute to the development of cancer and may also reduce the effectiveness of cancer treatments,” said George Kulik of Wake Forest University, the senior researcher on the project.
For full story with links to related research go here….

A week before the FDA advisory committee meeting on Dendreon’s Provenge, investment analyst Adam Feuerstein predicted that if Provenge is approved it could generate over $100 million in sales in 2008. Feuerstein’s estimate is based on a projected price of $30,000 per year per course of the vaccine. His model assumes increasing numbers of men living with (and dying of) metastatic androgen independent refractory prostate cancer (AIPrC) over the next decade.
(full story…)

In advanced cancer, anti-tumor therapies often work only partially or not at all, and tumors progress following treatment. Scientists have now linked a treatment-induced growth factor to the cancer’s future spread.

A team at Vanderbilt-Ingram Cancer Center team reports in the May issue of Journal of Clinical Investigation that radiation and chemotherapy increase circulating levels of the growth factor TGF-beta, circulating cancer cells, and tumor metastases in mice implanted with metastatic breast cancer.

Radiation therapy and the chemotherapeutic agents doxorubicin (Adriamycin) and docetaxel (Taxotere) all increased TGF-beta levels and accelerated metastasis, an effect that was blocked by neutralizing antibodies directed against TGF-beta.

Blocking TGF-beta in the model prevented tumor metastases, suggesting that drugs designed to block TGF-beta may be clinically useful in combination with primary therapies.
(full story…)

For an overview of 3 main types of immunotherapies, or therapeutic vaccines, irials for prostate cancer see Round Table meeting held on April 1, 2005 in Boston, Massachusetts. This meeting was paid for by Cell Genesys. Contents (with charts and explanatory cartoons):

FUNDAMENTALS OF TUMOR IMMUNOLOGY
RELEVANT TO PROSTATE CANCER IMMUNOTHERAPY
Charles G. Drake, MD, PhD
The Sidney Kimmell Comprehensive Cancer Center Johns Hopkins Medical Center

POXVIRUS VACCINES
Robert S. DiPaola, MD
The Cancer Institute of New Jersey

TUMOR CELL VACCINES
Jonathan Simons, MD
Emory University School of Medicine

DENDRITIC CELL VACCINES
Johannes Vieweg, MD
Duke University Medical Center

Cell Genesys says the 22 patients in their Phase 2 trial of GVAX who received the most effective tolerable dose — “the dose that is comparable to that being employed in the company’s ongoing Phase 3 program”– reached median survival of 35.0 months.

This trial enrolled men with hormone refractory prostate cancer. Cell Genesys previously reported final median survival results from its first multi-center Phase 2 trial of GVAX as 26.2 months.

“The survival results from the two, independent multi-center Phase 2 clinical trials compare favorably to the previously published median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care for these patients. The company’s ongoing Phase 3 program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate cancer.”

Read the full press release