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.”
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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

PSA velocity is a predictor of prostate cancer detection in men above age 60 as well as in younger men, according to findings presented at the annual meeting of the American Urological Association. William Catalona MD and colleagues presented evidence that PSA velocity “is significantly higher in men of all ages with prostate cancer compared to those without prostate cancer,” although the measure “performed the best in young men.” “Interestingly,” Catalona’s group writes, “the median PSAV in men with prostate cancer was less than 0.75 ng/ml/year regardless of age, suggesting that this threshold may be too high. Overall, this data confirms that PSA velocity is a useful tool for prostate cancer detection.”
Full story: PSA Velocity is a Signficiant Marker of Prostate Cancer in Older Men as Well as in Younger Men May 31, 2007

Novacea, Inc. (Nasdaq: NOVC) and Schering-Plough Corporation (NYSE: SGP) today announced that they have entered into an exclusive worldwide license agreement for the development and commercialization of Asentar™ (DN-101). Novacea is currently conducting a large international Phase 3 trial (ASCENT-2) evaluating Asentar in 900 patients with androgen-independent prostate cancer (AIPC). Asentar is a novel, proprietary, high-dose oral formulation of calcitriol, a potent hormone that exerts its effects through the vitamin D receptor (VDR). Full story:
Novacea and Schering-Plough Enter Into Worldwide Development and Commercialization Agreement for Asentar, a Novel Treatment for Prostate Cancer

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.
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Lack of cancer education, writes Aria White, NNPA Special Correspondent, causes desperate deaths for African-Americans. Because of a lack of education on cancer and cancer-prevention in the African-American community, African-Americans are more likely than any other race or ethnicity to die from cancer, according to medical experts, White reports.

”The problem is that we don’t do enough of what works,” says Sanya Springfield, Ph.D., Director of the Center to Reduce Cancer Health Disparities, in an interview.

According to the National Cancer Institute (NCI), African-American men are 35 percent more likely to die from cancer than White men and African-American women are 18 percent more likely to die from cancer than White women.

Cancer death disparities are top priority at the National Cancer Institute. The NCI’s Center to Reduce Cancer Health Disparities tries to determine the cause for such health disparities in minorities.

”The difficulty lies in funding, there are plenty of models out there that work, there just aren’t enough of them,” Springfield says.

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FoxNews (”Fair and Balanced”) aired Killer Bureaucracy: Why the FDA is Keeping Lifesaving Drugs from Cancer Patients May 19, 2007. Paul Gigot interviewed Dr. Scott Gottlieb. Scott Gottlieb MD, a stock analyst appointed to a top FDA job by President Bush in 2005, returned to Wall Street where he promotes Dendreon’s Provenge in his Forbes/Gottlieb Medical Technology Investor newsletter.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “True Man” or “Energy Max” products promoted and sold as dietary supplements throughout the United States. Both products — touted as sexual enhancement products and as treatments for erectile dysfunction (ED) — contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.

The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
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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.”
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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

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.”
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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:
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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. Ptobably, 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). The letter is signed by 19 prostate cancer advocacy groups including US Too International and National Prostate Cancer Coalition.
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Dr. Thomas R. Fleming, Ph.D., a prostate cancer survivor and nationally recognized statistician specializing in clinical trials design and analysis, has written a letter urging FDA officials not to approve Dendreon’s application at this time.

Echoing concerns about post-hoc analysis expressed by FDA statistical reviewer Dr. Bo-Guang Zhen, Fleming disagrees with a prostate cancer survivor on the FDA’s March 29 advisory committee who said that Dendreon’s sipuleucel-T (Provenge) vaccine offers "an opportunity to make a choice."

Fleming writes: "As a fellow person living with prostate cancer I strongly disagree with [this] statement that all patients want is a ‘choice.’ Patients want an ‘informed choice.’”

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This investigational drug is moving ahead in Phase III trials for late-stage chemotherapy resistant ovarian cancer. A company press release says findings from a study to be presented at the New Zealand Society of Oncology meeting May 9-11, “help explain the mechanism by which phenoxodiol induces cancer cell death.” More at Marshall Edwards Announces … Investigational Drug Phenoxodiol Targets Cancer Protein, Causing Cancer Cell Death May 1, 2007.