Seattle P-I reporter DAN RICHMAN in an article updated tonight writes:

Seattle-based Dendreon Corp. will delay releasing its much-anticipated Provenge drug to fight prostate cancer until at least next year and possibly until 2010, spokeswomen said Thursday.

Because of that delay, the company Thursday cut 15 percent of its 250-person work force, laying off the roughly 40 staffers who were preparing to begin marketing Provenge later this year, said one spokeswoman, Monique Greer, in an interview Thursday morning.

The Food and Drug Administration last week unexpectedly declined to approve Provenge, Dendreon’s only product, without more data supporting the drug’s effectiveness.

“We expect interim data in 2008, but it’s event-driven, by deaths or survival, so it could be 2010 until we have final-survival analysis,” Greer said in an interview Thursday morning. The drug will make it to the market “at the earliest in 2009, potentially,” she said.

She said the company plans to meet with the FDA in the near future and will base its next steps on the results of that meeting.

Full Story Seattled PI, Dendreon will Delay Provenge…

A site to advocate for “Provenge Now!” has been launched. Provenge is Dendreon’s immunotherapy for prostate cancer, which was approved 17-0 for safety and 13-4 for efficacy by an FDA Advisory Committee vote March 29th this year. On May 9, Dendreon announced that FDA has sent them a “Complete Response Letter,” commonly called an approvable letter, requesting more data. Dendreon CEO Mitchell Gold said “The FDA has requested additional clinical data in support of the efficacy claim.”

Tomatoes might be nutritious and tasty, say researchers based at the National Cancer Institute and Fred Hutchinson Cancer Research Center, but don’t count on them to prevent prostate cancer. Lycopene, an antioxidant predominately found in tomatoes, the researchers report in the May issue of Cancer Epidemiology, Biomarkers & Prevention, does not effectively prevent prostate cancer.

In fact, the researchers noted an association between beta-carotene, an antioxidant related to lycopene, and an increased risk for aggressive prostate cancer. In a preliminary report last year from the same study researchers noted that antioxidant supplements have weak, mixed results for prostate cancer.

No Magic Tomato? Study Breaks Link between Lycopene and Prostate Cancer Prevention … Full story

Recent studies have suggested that obese men have lower serum prostate specific antigen (PSA) concentrations relative to non-obese men. Researchers from centers across the USA hypothesized that the increased circulating plasma volume in men with higher body mass index (BMI) dilutes curculating PSA resulting in lower serum PSA concentrations on blood tests.

To test this they analyzed the relationship between serum PSA concentration, body mass index (BMI), plasma volume (calculated based upon age and estimated body surface area) and total PSA mass (PSA concentration multiplied by plasma volume) using a linear regression model adjusting for age at surgery, race, year of surgery, clinical stage, SEARCH site, pathological Gleason sum, extracapsular extension, surgical margins, seminal vesicle invasion and prostate specimen weight among 1304 men who underwent radical prostatectomy within the Shared Equal Access Regional Center Hospital (SEARCH) Database between 1991 and 2006.

Results: After controlling for clinical and pathological factors, higher BMI was significantly associated with higher plasma volume (p=0.005, see table) and lower PSA concentrations (p<0.001). There was no significant association between BMI and adjusted PSA mass (p=0.52).

Conclusions: In a cohort of men with prostate cancer, hemodilution due to greater plasma volume explained all of the lower serum PSA concentration observed among obese men. Future studies are needed to confirm these findings and to assess whether this phenomenon of tumor marker dilution occurs among obese people with other cancers as well. If confirmed, these findings may have broad implications for cancer screening in general among obese people.

Article title authorships:

CAN HEMODILUTION EXPLAIN THE LOWER PSA CONCENTRATIONS AMONG OBESE MEN?

Lionel L Baez, MD, Robert J Hamilton, MD, Robin T Vollmer, MD, Judd W Moul, MD, Christopher L Amling, MD, Christopher J Kane, MD, William J Aronson, MD, Matha K Terris, MD, Joseph C Presti, Jr, MD, Stephen J Freedland, MD. Duke University Medical Center, Durham, NC; Durham VAMC, Durham, NC; University of Alabama at Birmingham, Birmingham, AL; VAMC San Francisco, San Francisco, CA; VA Greater Los Angeles Healthcare System, Los Angeles, CA; VAMC Augusta, Augusta, GA; VAMC Palo Alto, Palo Alto, CA

One of the problems with photodynamic therapy is that patients may remain over-sensitive to light for weeks afterwards, or even suffer from burns in tissue close to the target area. Now, research scientists in Canada have taken a step forward by using an enzyme found in specific cancer cells to help light a “photodynamic molecular beacon” inside the cell. The method may make it easier to target tumors without damage to surrounding healthy tissue.
Full story:
Researchers Create New Photodynamic Molecular Beacon to Help Target Tumors and Minimize Side Effects

In today’s Wall Street Journal, Mark Thornton, M.D., Ph.D. deplores the FDA’s decision on Dendreon’s sipuleucal-T immunotherapy (Provenge vaccine). Dr. Thornton says “May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday. Within an eight-hour period that day, the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient’s immune system against cancer. The FDA’s hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers.”

The Seventh International Prostate Cancer Congress to be held at The Fairmont Turnberry Isle Resort & Club in Aventura, FL from July 27-29 will include presentations on prostate cancer immunotherapy and vaccines by urologist Paul Schellhammer, Professor of Urology at Eastern Virginia Medical School and consultant to Dendreon, Corp., and oncologist Susan Slovin, a Memorial Sloan- Kettering immunologist who is working on bivalent and multivalent vaccines targeted at different arms of the immune system. Program details:

Thousands of men who opt for surgical removal of the prostate as their primary treatment for prostate cancer have to face the risk of post-operative urinary incontinence.

Now a team of urologic surgeons at NewYork-Presbyterian Hospital/Weill Cornell Medical Center has devised what they describe as a simple, effective means of reconstructing key anatomical structures that ensure continence.

The new method hastens recovery of urinary continence for patients with early-state, localized, non-aggressive tumors, they say. Probably, it will have no impact on the small minority of patients who endure long-term failure to recover urinary continence. Full story:
Collar Reconstruction Procedure During Robotic Prostate Surgery Speeds Recovery of Urinary Control, Team Says

Dendreon’s CEO Mitchell Gold traded some of his stock during the high period following the FDA Advisory panel vote on his company’s prostate cancer immunotherapy sipuleucal-T (Provenge). Gold told the WSJ Health blog that he sold “less than 20%” of his holdings in the company following the upbeat FDA advisory panel vote. “it’s all public,” he said, without elaborating.

More of a surprise is to see that Steve Fleischmann, one the patients who spoke passionately to the FDA committee, did the same:

Before the stock tanked some savvy investors cashed in. One of them was businessman Steve Fleischmann, who became a prostate cancer patient, activist and Dendreon shareholder all in the same year. “I bought Dendreon in 2003;I’ve owned it for years,” he told the Health Blog. But he shed some of his shares after Dendreon surged at the end of March on a panel of experts’ recommendation that FDA approve the vaccine. He declined to quantify his holdings or profits, but said, “I wanted to take some of my chips off the table so I wasn’t so invested. It’s natural.”

Still, Fleischmann decried the protracted tug of war among investors in the company: “The sad thing is that Dendreon became more of a stock play than a humanistic play — a game between longs and shorts — and all about padding people’s pockets.”

Wall Street Journal Health Blog

Raise a Voice, an advocacy group for advanced prostate cancer patients, which is calling for patient access to drugs that have passed through Phase I trials, has written a thank you letter to the FDA Advisory Committee on Dendreon’s sipuleucel-T (Provenge).