The men’s health company GTx has announced two sets of of interim results in the past month from its pivotal Phase III clinical trial of Acapodene (toremifene citrate) for the treatment of side effects of androgen deprivation therapy (ADT) for prostate cancer.
(full story…)

COX-2 inhibitors are a class of drugs that have been shown to have some anti-tumor activity against human prostate cancer, both in the lab and in tests on humans. German researchers wanted to find out if combining COX-2 inhibitors with radiation therapy causes more severe side effects than radiation alone. They conducted a Phase I trial to test this.
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Zoologist Dr Lawrence Williams, a research consultant with the Scientific Research Council of Jamaica, says he and colleagues in Germany have been able to produce an anti-cancer compound, dibenzyl trisulphide (DTS), from guinea hen weed (petiveria alliacea), which grows wild across Jamaica.

In an interview with the Jamaica Observer, Dr. Williams said he is ready to take his research to the next level - the use of the compound on mice induced with cancer and an investigation into the side effects, including DTS’s impact on the kidneys and the liver. The work is to cost an estimated US $150,000.
(full story…)

Wary of Backlash, Cancer-Drug Makers Weigh Price Limits
Wall Street Journal
By JOHN CARREYROU and GEETA ANAND
May 10, 2006; Page B1
As high prices of cancer drugs spark the kind of patient outrage that high AIDS-drug prices unleashed more than a decade ago, a few pharmaceutical and biotech companies are weighing caps and other cost-containment measures, before the outcry turns into a public-relations crisis for the industry.

ImClone Systems Inc. and Bristol-Myers Squibb Co., co-marketers of Erbitux, one of the most expensive cancer drugs on the market, are “well down the road” toward establishing an annual patient price cap for the drug if its market expands, says Ronald Martell, senior vice president of commercial operations at ImClone. Such a program would set an annual ceiling on individual patients’ drug-treatment costs, beyond which companies would provide the drug free of charge or at a steep discount. Genentech Corp., of South San Francisco, Calif., is considering cost-containing alternatives for Avastin, which is currently approved for treatment of early-stage colorectal cancer.
While the backlash against cancer-drug prices is nowhere near as big as the one against AIDS-drug prices, ImClone’s Mr. Martell says the industry should make changes in its policies now. “Otherwise, at some point there will be a confluence of events — social pressure, volume of dollars — and something will have to give,” he warns.

Erbitux, priced at $10,000 a month, is currently approved only for patients with metastatic colorectal cancer who have failed a certain kind of chemotherapy. Their average total cost of treatment is currently about $40,000: In most of these patients, the illness has advanced to the point where they are only a few months from death.

But later this year, ImClone and Bristol-Myers, both based in New York, hope to win Food and Drug Administration approval to market Erbitux for patients in earlier stages of colorectal cancer, who have longer life expectancies. Approval for these patients would result in a sharp rise in the average cost of treatment with Erbitux — and a sharp rise in profits.

In the case of Genentech’s Avastin, the current cost of treatment — $4,400 a month, or $52,000 a year — could rise sharply if the FDA approves the drug as a treatment — at double the dose — to treat lung cancer and breast cancer. Such approvals, expected over the next year, could result in thousands of new patients paying, at current prices, more than $100,000 a year to take Avastin.

The Medicare Modernization Act of 2003, which extended prescription-drug benefits to the elderly, has put financial pressure on elderly cancer patients, the age group with the highest rates of the disease. Under the old system, cancer patients receiving drugs intravenously at a hospital in practice often weren’t forced to make their 20% co-payment: The hospital would bill Medicare directly, and the Medicare reimbursement price — as much as 25% above the drugs’ market price — provided a sufficient profit cushion so that hospitals often didn’t collect co-payments.

But now, Medicare reimbursements are in line with drugs’ actual selling prices, and physicians and hospitals can no longer afford to forgive co-payments. As a result, many elderly cancer patients without supplemental prescription-drug insurance end up on the hook for thousands of dollars.

“There’s a groundswell of patients who are outraged,” says Jerry Flanagan, health-care policy director for the Foundation for Taxpayer & Consumer Rights, a Los Angeles watchdog group.

Full story at Wall Street Journal: Wary of Backlash, Cancer-Drug Makers Weigh Price Limits
By JOHN CARREYROU and GEETA ANAND
May 10, 2006; Page B1 May require subscription or initial ad view.

Havana, May 5 (Prensa Latina) The Center of Genetic Engineering and Biotechnology (CIGB) of Camaguey Province submitted a candidate vaccine to the National Medicine Control Center to begin clinical tests, part of its quest for a recombinant vaccine and therapy for prostate cancer.

Assistant Research Director Eulogio Pimentel said the CIGB is conducting research on several types of cancer, sometimes involving joint work with other institutions, such as the Molecular Immunology Center that has already developed similar projects for lung, breast, head, neck and prostate cancer.
(full story…)

Biomira Announces Final Phase 2b Survival Results of Stimuvax® (formerly known as BLP25 Liposome Vaccine) Trial in Patients With Non-Small Cell Lung Cancer

Results Confirm Median Survical of 30.6 Months in Stage IIIB Patients on Vaccine Versus 13.3 Months in Control Patients

Targeted Nanoparticles Destroy Prostate Tumors

Biodegradable polymer nanoparticles, linked to a protein-binding nucleic acid known as an aptamer and loaded with the anticancer agent docetaxel, can target and kill prostate tumors growing in mice. Using this targeted nanoparticle to deliver docetaxel appears to reduce the toxic side effects associated with this drug.
(full story…)

United Press International - Health Business - GTx begins trial of prostate-cancer drug
GTx begins trial of prostate-cancer drug

MEMPHIS, April 21 (UPI) — GTx said Friday it is initiating a phase 3b trial of Acapodene in men undergoing androgen deprivation therapy for prostate cancer.

Prostate-cancer patients who have completed the full two-year treatment course in the pivotal phase 3 trial of Acapodene will be eligible to participate in the phase 3b trial for an additional year, GTx said. The aim of the phase 3b trial is to collect additional data about fractures and safety. Acapodene is intended as a treatment of the side effects of androgen deprivation therapy for advanced prostate cancer.

The company noted that the phase 3b study is considered a separate study and will not affect its anticipated timeline for submitting the new drug application for Acapodene. The phase 3b study also will not affect the expected completion date of the phase 3 pivotal trial in the second half of 2007.

The phase 3 trial, which is determining whether Acapodene reduces vertebral fractures and improves bone mineral density, completed enrollment in 2005. An interim analysis showed a positive change in bone mineral density in patients treated with Acapodene compared to the placebo group.

Epigenomics, a molecular diagnostics company developing tests based on DNA
methylation, is developing a test for the methylation of a single gene, PITX2, that can predict recurrence of prostate cancer after radical surgery. This new test is not yet available but it looks worth watching out for. The same company is developing a blood test for early detection of colon cancer. The company presented study results this week at 97th AACR Annual Meeting in Washington D.C., USA. Full stories:

Clinical Study Proves Prognostic Power of Epigenomics’ Biomarker in Prostate Cancer

Epigenomics Presents Data Confirming Screening for Methylated DNA in Blood as Key to Early Colorectal Cancer Detection

In the past few years we have reported on a number of studies indicating that aspirin and other NSAIDs (non steroidal anti-inflammatory drugs) may protect men against prostate cancer. For example:

Use of aspirin or other NSAIDs increases survival for men with prostate cancer October 5, 2004.

But one study of NSAIDs and cancer turned out to be fake. In April 2005 Dr. Jon Sudbø reported at the annual meeting of American Association for Cancer Research in Anaheim, CA that NSAIDs prevent some cancers but increase cardiovascular deaths. His paper was published in a leading medical journal. But in January 2006 the entire study was revealed as a fake built from fabricated data.

Now a Canadian team has confirmed that men who take non-steroidal anti-inflammatory drugs may receive protection against prostate cancer.
(full story…)

A new method of delivering chemotherapy to cancer patients without incurring side effects such as hair loss and vomiting is being developed.

The method, produced at the University of Bath, involves using tiny fibres and beads soaked in the chemotherapy drug which are then implanted into the cancerous area in the patient’s body.

These fibres are bio-degradable and compatible with body tissue, which means they would not be rejected by the patient’s body. They gradually turn from solid to liquid, releasing a regular flow of the chemotherapy chemical into the cancer site, and a much lower dose to the rest of the body.
(full story…)

Animal tests on the kind of drug given to the six men ill in a London hospital may not be the best way of evaluating the effects in people, an expert warns.

The drug they took stimulates a protein only found in humans.

Dr David Glover, an expert in drug testing, said this meant animal tests of medicines of this sort might give falsely reassuring results.

He said it might be better to look at innovative ways of testing small amounts of such drugs on people.
Full story from BBC: BBC Animal tests ‘false reassurance’

Capsaicin, the pungent alkaloid in jalapeños and other chile peppers that makes them hot, drives prostate cancer cells to kill themselves off, according to studies published in the March 15 issue of Cancer Research. See:
http://www.psa-rising.com/eatingwell/peppers_hot.htm

Some commentators reacted by warning that hot peppers may cause gastric cancer. Is this true? How strong is the association?

A study conducted at a Texas Veterans Administration hospital in 1988, published in the JAMA, injected about an ounce of jalapeno pepper directly into the stomachs of volunteers. Follow-up observation showed no damage to their stomach linings. But this did not amount to chronic exposure, and anti-cancer versus cancer-causing effects of capsaicin are still controversial. A couple of years ago Mexico National Institute of Public Health found higher rates of gastric cancer in people who ate the equivalent of 9-25 jalapeno peppers a day compared to people who no more than 3 a day. They found no evidence that bacterioa known to be associated with some types of stomach were causing this increased risk.
(full story…)

Today’s New York Times is running a story by Alex Berenson in the business section about Genentech’s Avastin, A Cancer Drug Shows Promise, at a Price That Many Can’t Pay. “Doctors are excited about the prospect of Avastin, ” Berenson writes, “a drug already widely used for colon cancer, as a crucial new treatment for breast and lung cancer, too. But doctors are cringing at the price the maker, Genentech, plans to charge for it: about $100,000 a year.”
(full story…)

Drug companies stop recruiting for cancer drug test after deaths
PAUL ELIAS
AP via Miami Herald reg Tue Feb 14 200
SAN FRANCISCO - Biotechnology giant Genentech Inc. and its majority stockholder Roche Holding AG said they temporarily halted recruiting volunteers for a large human test of the blockbuster cancer drug Avastin after more patients than expected died.

The deaths occurred among colon cancer patients taking Avastin with a chemotherapy regimen called XELOX. Since the test was started in December 2004, seven patients taking that combination died, four of them suddenly, Roche said in a press release Monday.

“An occurrence of sudden deaths, especially in three younger patients, was noted,” Roche said, adding that the temporary suspension would allow “a full safety assessment.”

Those seven deaths compare to four deaths in another arm of the study that combined Avastin with a different chemotherapy called FOLFOX.

About 2,000 of the 3,450 patients planned for the test already receiving one of three combinations of Avastin and the chemotherapy regimens will continue to receive their drugs. The rest of the volunteers won’t be enrolled for at least 60 days while the companies try to find what caused the deaths.

The test is designed to see if Avastin can safely be used to prevent colon cancer from recurring in patients in remission. The Food and Drug Administration approved Avastin for patients with advanced colon cancer in 2004 and the drug accounted for $1.1 billion in sales for Genentech last year. Basel, Switzerland-based Roche owns sales rights in Europe, where it was approved last year.
Full story online:
http://www.miami.com/mld/miamiherald/13867271.htm

QLT says therapy fails Phase II trial

Canada’s QLT, a Vancouver-based developer of light-activated pharmaceuticals, says that it is suspending work on an experimental therapy for
enlarged prostate because the drug “did not meet the study’s primary efficacy objective at three months.”

Researchers announced that lemuteporfin failed to significantly decrease
symptoms of benign prostatic hyperplasia after three months of treatment
compared with a placebo.

“While the decrease in AUA (American Urological Association) Symptom Score was consistent with that seen after other minimally invasive therapies there was no significant difference between treatment and sham-control groups.”

“The preliminary result of this trial does not support initiation of Phase
III clinical trials of lemuteporfin in BPH at this time,” commented Bob
Butchofsky, QLT’s acting chief executive officer. “We intend to complete the
analysis of the data, including the six-month measurements, in order to
determine the best path forward.”

source: QLT’s press release, February 14, 2006.

2006-02-10 10:16:19 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Adding arachidonic acid, an omega-6 fatty acid, to culture media causes prostate cancer cells to grow twice as fast as usual, according to a report in the February 1st issue of Cancer Research.

“Investigating the reasons for this rapid growth, we discovered that the omega-6 was turning on a dozen inflammatory genes that are known to be important in cancer,” lead author Dr. Millie Hughes-Fulford, from the San Francisco VA Medical Center, said in a statement.

Further analysis indicated that arachidonic acid was activating these genes through a PI3-kinase pathway known to play a key role in the pathogenesis of cancer.

Adding an NSAID or a PI3-kinase inhibitor to the culture media blocked the arachidonic acid-induced proliferation of prostate cancer cells, the findings indicate.

In light of the current findings, Dr. Hughes-Fulford said she now avoids cooking with corn oil, which is known to be high in omega-6 fatty acids. “I’m not a physician, and do not tell people how to eat, but I can tell you what I do in my own home. I use only canola oil and olive oil.”

Cancer Research, Feb 1, 2006.
Arachidonic Acid Activates Phosphatidylinositol 3-Kinase Signaling and Induces Gene Expression in Prostate Cancer
Millie Hughes-Fulford1,2,3, Chai-Fei Li, Jim Boonyaratanakornkit and Sina Sayyah
Department of Veterans Affairs Medical Center; Northern California Institute for Research and Education; and University of California, San Francisco, California

News Source: Reuters Health

LAURAN NEERGAARD
Associated Press

WASHINGTON - The dog hopped on three legs, pain from bone cancer so bad that he wouldn’t let his afflicted fourth paw touch the floor. His owner was bracing for euthanasia when scientists offered a novel experiment: They injected a fiery sap from a Moroccan plant into Scooter’s spinal column - and the dog frolicked on all fours again for several months.

The chemical destroyed nerve cells that sensed pain from Scooter’s cancer, not helping the tumor but apparently making him no longer really feel it.

The dramatic effect in dogs has researchers from the National Institutes of Health preparing to test the chemical in people whose pain from advanced cancer is unrelieved by even the strongest narcotics.

The first human study could begin by next year, at the NIH’s Bethesda, Md., hospital. A second study in pain-ridden dogs is slated for this summer at the University of Pennsylvania.
Full story available from these sources:
Plant could hold secret for new pain medication Seattle Times

Sap from `hot’ plant treats pain, Good results on dogs with cancer
Researchers eye future use on humans Toronto Star, Jan. 17,

Follow up to the Oslo fabrication. Dr. Sudbø is not in hiding, but he is “on sick leave” and cannot be reached. His wife and his twin brother, who are both scientists, worked with him on the The Lancet study, according to the Guardian, but were unaware of his fraud.

No way of knowing as yet if any statements about the effect of NSAIDs on oral cancer in his article are true. It’s plain though that Dr. Sudbø assembled no genuine evidence for anything that he claimed in this study. He created a simulated reality, a database of pretend patients.
(full story…)

Last April PSA Rising ran a brief report of a Norwegian study that claimed that “Non-steroidal anti-inflammatory drugs (NSAIDs) prevent some cancers but . . . the advantage from NSAID protection against oral cancer was wiped out by double the rate of heart attack or stroke.”

This weekend it was evident that this study of the effects of ibuprofen and naproxen on oral cancer was fabricated from A to Z.

Norwegian hospital officials stated last week that the study was faked. Today, according to Reuters, the hospital in Oslo said: “A Norwegian cancer expert made up fictitious patients for an article about treatment of oral cancer published in a leading medical journal. . . .”

“The material was fabricated,” said Trine Lind, spokeswoman of the Norwegian Radium Hospital where Jon Sudbo has worked as a doctor and a researcher. “We are shocked. This is the worst thing that could happen in a research institution like ours.”

The hospital spokeswoman said Sudbo, 44, “invented patients and case histories for a study of oral cancer that was published in the British medical journal the Lancet in October 2005.”

The Lancet is Britain’s leading medical journal.

ANNE MARTE BLINDHEIM in the Norwegian daily Dagbladet reported Friday Frykter norsk lege har jukset før that “250 of his sample of 908 people in the study all shared the same birthday,” Reuters said.

Stein Vaaler [photographed below], strategy director for the Oslo cancer center, said: “A colleague raised questions about the article when it was published,” and (according to reports by Canadian CTV and Associated Press ( Cancer researcher admits to fabricating data) “when the researcher was confronted this week about the data, he acknowledged the fabrication, Vaaler said.”

Norwegian media are calling the situation “a personal tragedy.”

“All of it was fabricated,” Vaaler said. “It was not manipulation of real data — it was just complete fabrication.”
(full story…)