That news comes from Dendreon, the company that makes Provenge.

"We believe this is truly a breakthrough for the prostate cancer community and a testament to the promise of the field of cancer immunotherapies," Dendreon’s president and chief executive officer Mitchell Gold, MD, said in a conference call today.

Provenge is a biologic drug given by infusion to spur the immune system to fight advanced prostate cancer that doesn’t respond to anti-androgen treatment.

In 2007, an FDA advisory panel recommended that the FDA approve Provenge. But instead, the FDA requested more information about whether Provenge prolongs survival.

That request led to a new study of 512 men with advanced prostate cancer. Those men had metastatic, androgen-independent prostate cancer, meaning their cancer had spread and wasn’t responding to anti-androgen treatment.

In that study, overall survival was significantly better for men taking Provenge than those taking a placebo.

The study’s results were "unambiguous" and "very consistent" with previous Provenge trials, Gold says.

Dendreon plans to submit the study’s results to the FDA in the fourth quarter of 2009; after that, the FDA will have six months to review the material, Gold says.

"This data supports Provenge being used as front-line treatment in men with metastatic, androgen-independent prostate cancer," says Gold, who notes that no new side effects from Provenge stood out in the study. In previous trials, the most common side effects in men taking Provenge were chills, fever, headache, fatigue, shortness of breath, vomiting, and tremor, mainly at a low level and for one to two days following infusion.

Gold says that those men would first have surgery or some form of local therapy, then anti-androgen therapy if their cancer recurred, and if their PSA levels rose after that, "Provenge would come into play as a potential treatment option for them."

In men with prostate cancer, PSA (prostate-specific androgen) levels are used to gauge the success of prostate cancer treatment.

Dendreon isn’t releasing any further details of the study until April 28, when the findings will be presented at the American Urological Association’s annual meeting in Chicago.

The technology used to make Provenge may also prove useful against other forms of cancer, Gold says.

Prostate Cancer Vaccine Meets Goal – Health updates

The figures mean that on average, a new cancer patient was being diagnosed in the country every 7 minutes, 10 seconds in 2006, up slightly from the average of 7 minutes, 38 seconds in 2005, when 68,907 new cases were recorded, according to Chao Kun-yu, deputy chief of the DOH’s Bureau of Health Promotion.

The report showed that for the first time, colorectal cancer replaced liver cancer as the most common type among new cases recorded in a single year.

Compared with 2005, the number of new colorectal cancer cases rose by 644 to 10,248 in 2006, and liver cancer or intrahepatic bile duct cancer was found among 10,092 people – a jump of 176 cases.

Chao attributed the increased prevalence of colorectal cancer among Taiwanese to increasingly unhealthy dietary habits, such as high consumption of red meat and fat and low fiber intake.

Although people between ages 50 and 69 are advised to have fecal occult blood tests every two years to help early diagnosis of colorectal cancer, DOH statistics indicate that only 11 percent of that age group received the tests in 2008 or 2007, he said.

The third highest number of new cases in 2006 were cancers of the lung, trachea or bronchus, totalling 8,748, followed by breast cancer among women, 6,895 cases; and cancer of the mouth, oropharynx or hypopharynx, 5,352 cases, according to the report.

Rounding out the list of top 10 most common types of cancer in 2006 were stomach cancer, with 3,794 new cases; prostate cancer, with 3,073 new cases; skin cancer, with 2,457 new cases; cervical cancer, with 1,828 new cases; and uterine cancer, with 1,159 new cases.

In terms of age-adjusted incidence rate, an average 50 per 100,000 women were diagnosed with breast cancer in 2006; 37.44 per 100,000 people were diagnosed with cancer of the liver or intrahepatic bile duct cancer; and 37.35 per 100,000 people were found to have colorectal cancer.

The report revealed that in Taiwan, the risk of cancer among men was 1.4 times higher than among women.

Because of an almost exclusively male habit of chewing betel nuts, the age-adjusted incidence rates of esophageal cancer and oral cancer among men were 15.6 times to 10.4 times higher than among women in 2006, the report stated.

However, women were found to develop cancer at an earlier age than men, with the median age at diagnosis being 59 among women and 65 among men.

Colorectal cancer most common:

The so-called Million Women Study of middle-aged women in the United Kingdom found that low to moderate consumption of alcohol increased the risk of and might be responsible for 13 percent of breast, liver, rectal and certain digestive tract cancers.

Researchers determined that only one glass of wine a night might raise the risk of cancer in women.

While prior studies indicated that moderate alcohol consumption could be good for heart health, it now appears that cancer risks from consumption may outweigh the possible cardiovascular benefits.

Oncologists endorsed the findings saying that they had promoted a healthy lifestyle for some time as primary means of reducing cancer risk.

According to the Million Women Study, for every additional drink regularly consumed per day, the increase in incidence up to age 75 years per 1000 for women in developed countries is estimated to be about 15 excess cancers per 1000 women up to age 75.

Million Woman Study Links Alcohol Use to Cancer in Women – Health Updates

If a man has smoked marijuana on a weekly basis or has been exposed to hashish for an extended period of time, the chances of testicular cancer double compared to someone who has never smoked marijuana.

The study found that marijuana could also decrease sperm quality, decrease testosterone levels and cause impotency, since these are similar side effects of testicular cancer.

Men already produce a “cannabinoid-like chemical,” which protects the reproductive system from cancer, but marijuana use could reverse that protective chemical and instead work against the body. The marijuana link is somehow associated with “nonseminoma,” malignant germ cell tumors, and is increasing the risk.

The study has prompted more research as it has open up a bevy of questions, said Stephen Schwartz, a member of the Public Health Sciences Division at the Hutchinson Center.

Testicular cancer linked to marijuana use

While it may sound odd to treat cancer with a drug that acts on bone, evidence is accumulating that such drugs may do more than just prevent the loss of bone. Other studies are testing the drugs in patients with prostate or lung cancer.

The new study, published in Thursday’s New England Journal of Medicine, involved 1,803 premenopausal women with tumors that were fueled by estrogen. As part of their treatment, all received drugs that shut down their ovaries, preventing them from making estrogen, along with drugs that stymie cancer cells from using estrogen to grow.

Half also got the bone drug zoledronic acid, or Zometa, as an intravenous infusion twice a year for three years. Those who took the drug had a 36 percent reduction in cancer recurrences and metastases, compared with women who did not get it. After nearly four years, 54 women who received zoledronic acid and 83 who did not had a recurrence of their cancer or had a new cancer in the opposite breast or a metastasis to their bones.

Some cancer researchers said they wanted to see the results from two other large studies of bone drugs and breast cancer before advocating that all women with breast cancer get such drugs. The studies, which include both premenopausal and postmenopausal women, are nearing completion, and their results should be available within the next few years. But the new study has buoyed researchers’ hopes.

“This is really a landmark study,” said Dr. James N. Ingle, head of the breast cancer research program at the Mayo Clinic Cancer Center. “It’s a reason for real enthusiasm.”

But for now, he said, “I think it is the general consensus that we are not ready to make this a standard treatment.”

Others are more persuaded.

Dr. Marc E. Lippman, a breast cancer expert who is chairman of the department of medicine at the University of Miami, said many women taking hormonal therapy for breast cancer already take drugs to protect their bones. The hormonal therapy deprives the body of the bone-building effects of estrogen. So, he said, why not give these women zoledronic acid, the bone drug used in the study?

“This is something of a mitzvah,” Dr. Lippman said. “The very therapy you might want to do to counteract the toxicity” of the hormonal therapy “has an additional advantage.”

“I think you have to give it,” he said.

The idea of using a drug like zoledronic acid arose from research into why some cancers, like breast cancers, have a predilection to spread to bone.

One reason, Dr. Ingle said, is that cancer cells interact with a type of bone cell, osteoclasts, whose role is to break down bone. Breast cancer cells that migrate to the bones stimulate osteoclasts. Osteoclasts then produce substances that stimulate the cancer cells.

“You get this vicious cycle,” he said.

Drugs used to treat osteoporosis, the bone-thinning disease that often occurs in the elderly, home in on osteoclasts and stop them from releasing substances that cause bone loss. As the osteoclasts stop working, they die.

So the idea arose: Perhaps osteoporosis drugs might prevent cancer cells from growing in bones.

Other studies of the osteoporosis drugs, known as bisphosphonates, indicated that they might also have other anticancer effects. In the laboratory, at least, they stopped cancer cells from growing new blood supplies. And bisphosphonates made cancer cells self-destruct in laboratory studies.

In addition, said Dr. Eric P. Winer, a breast cancer specialist at the Dana-Farber Cancer Institute in Boston, still other studies indicated that bisphosphonates affected how well cancer cells stuck to surrounding tissue and whether they were able to invade other tissue and proliferate.

And, said Dr. Michael Gnant of the Medical University of Vienna, the lead author of the new study, recent research indicates that particularly in the early stages of many cancers, there is a population of tumor cells that migrate to the bones and hide in bone marrow. Bisphosphonates, he said, might squelch those cells, affecting the ability of the disease to recur.

“This is a general mechanism for all cancers,” Dr. Gnant said. “Not just cancers that metastasize to bone.”

The idea for the cancer studies began when researchers, like Dr. Trevor J. Powles, a professor of breast oncology at Parkside Oncology in London, started asking whether bisphosphonates could treat cancer that had already spread to bone. They could, it turned out, and zoledronic acid and other bisphosphonates were subsequently approved for that use and shown to prevent further spread of cancer in bones. In fact, Zometa is approved only for bone complications of cancer, like fractures — it is not licensed as an osteoporosis drug.

Those discoveries led Dr. Powles and his colleagues and, independently, two other groups of researchers, to ask whether the drugs, in the high doses used to treat cancer, might prevent breast cancer from spreading in the first place.

The results, published a few years ago, were mixed. Dr. Powles’s study found that when women took a bisphosphonate their cancer was less likely to spread to their bones and they lived longer. Another study also found that the cancer was less likely to spread. But the third study found no effect.

Dr. Gnant, in the meantime, had begun a much larger study with intravenous zoledronic acid at a much lower dose, given twice a year for three years. The concern with the drug is a rare and very serious side effect, osteonecrosis of the jaw. But in this study at least, it did not occur.

And the surprising result of his study, if it holds up, indicates that zoledronic acid could add a benefit to existing breast cancer therapy that is nearly the same magnitude as the benefit conferred by chemotherapy or hormonal therapy alone.

But Dr. Gnant urges caution.

“While everyone is very excited, we still need to be conservative about what we recommend to patients,” he said. “In clinical science we do clinical trials. I am still hesitating to say, ‘Well, this is good for everyone.’ In the history of science we sometimes extrapolated and turned out to be absolutely wrong.”

“The right way to proceed,” Dr. Gnant said, “is to wait for data to come in from other studies.”

Bone Drugs May Help Fight Breast Cancer

Antisoma and Novartis have a worldwide development and commercialisation agreement for ASA404. Trials in breast cancer will be in addition to two ongoing pivotal phase III trials in patients with non-small cell lung cancer, one (ATTRACT-1) testing ASA404 as a first-line treatment and the other (ATTRACT-2) evaluating ASA404 as a second-line treatment. Because ASA404 acts by disrupting tumour blood vessels, it has potential application against a variety of solid tumours, all of which depend on tumour blood vessels to survive and grow.

Glyn Edwards, Antisoma’s CEO, said: “We are very pleased that Novartis is extending the development of ASA404 to metastatic breast cancer. This represents a significant additional opportunity for ASA404. While there have been many advances in the treatment of breast cancer, there remains a great need for new and innovative approaches, especially for patients with metastatic cancer.”

About metastatic breast cancer

Worldwide, more than a million women are diagnosed with breast cancer and over 400,000 die from the disease each year. Metastatic breast cancer is the most advanced stage (stage IV). Over 100,000 patients present with stage IV disease each year in the US, Europe and Japan.

About ASA404

ASA404 (DMXAA) is a small-molecule Tumour-Vascular Disrupting Agent (Tumour-VDA) which selectively targets the blood vessels that nourish tumours. The drug was discovered by Professors Bruce Baguley and William Denny and their teams at the Auckland Cancer Society Research Centre, University of Auckland, New Zealand. It was in-licensed by Antisoma from Cancer Research Ventures Limited (now Cancer Research Technology), the development and commercialisation company of the Cancer Research Campaign (now Cancer Research UK), in August 2001. In a randomised phase II study in non-small cell lung cancer, addition of ASA404 to standard first-line chemotherapy was associated with a 5 month improvement in median survival. Worldwide rights to the drug were licensed to Novartis AG in April 2007.

About Antisoma

Antisoma is a London Stock Exchange-listed biopharmaceutical company that develops novel products for the treatment of cancer. The Company has operations in the UK and the US. Please visit www.antisoma.com for further information about Antisoma.

ASA404 to be developed in breast cancer

Far more potent than similar compounds already in clinical trial, the drug short-circuits the normal ability of cells to sense the need to grow and divide — a signal that cancer cells exploit to spread in the body.

The scientists are working with clinicians to test the drug’s effectiveness against a range of cancers that have proven difficult to treat.

The discovery is reported in the Feb. 10, 2009 edition of PLoS Biology, a journal published by the Public Library of Science.

The research was led by scientists at the University of California, San Francisco (UCSF) and the UCSF Helen Diller Family Comprehensive Cancer Center. Senior author of the paper is Kevan Shokat, PhD, Howard Hughes Medical Investigator and professor of cellular and molecular pharmacology at UCSF.

Normally, in response to growth signals, a multi-protein unit in cells called mTOR integrates information about the cell’s nutritional and energy needs, and prompts the cell to manufacture key proteins for cell growth. But cancer exploits this signal for its own growth.

Clinical trials are underway to stymie cancer proliferation by using a drug called rapamycin—marketed as Rapamune–or related compounds to block the growth signal cycle. The new drug greatly improves on rapamycin’s effectiveness, the scientists reported. The name mTOR stands for “mammalian target of rapamycin.”

Of serious concern to clinicians, rapamycin and related drugs can actually promote cancer at the same time they thwart it. This happens, the scientists found, because the drugs only partially block the cells response to a growth signal. When this happens, the drugs end up augmenting the growth signal itself because a feedback process in the cell kicks in to assure adequate nutrition. With the feedback system in play, cancer cells can regain needed nutrients and continue to proliferate.

The new drug totally blocks this feedback loop, said Shokat, who also is a faculty affiliate at the California Institute for Quantitative Biosciences, known as QB3, which is headquartered at UCSF.

“We were trying to synthesize compounds that could help us learn more about how cancer exploits normal growth controls,” he explained. “Once we made it, though, we found it was even better than we thought it would be at blocking mTor signaling. It does everything that rapamycin does and more.”

The new drug succeeds because there are two mTOR signal pathways, and it blocks both, the scientists found. Rapamycin only blocks one, and so allows the growth-signaling system to still function.

The scientists think that the drug’s total blockage of the nutrient-sensitive mTOR and its feedback loop offer a major advance over rapamycin based drugs, which have been approved to treat only renal call carcinoma effectively.

“I hope the new drug can be used to treat a range of cancers,” Shokat said. “We will work with clinicians to test it against a number of types of cancer – colorectal, lung, breast, multiple myeloma and others. We want to first find the cancer that is most sensitive to it.”

The new compound has been dubbed a TORKinib because it inhibits the mTOR signal. UCSF has applied for a patent and licensed the patent to a startup biotech company, co-founded by Shokat and colleagues, to advance its use in clinical trials to treat cancer.

mTOR is known as a kinase, a ubiquitous type of signaling molecule – there are more than 500 different kinases in the body – that essentially switches proteins on or off. The switch is one of the most common interactions in the body. The kinase adds a small molecule known as a phosphate group to the protein, and that single action either turns on the protein or dampens its activity.

Like all signaling systems in the body, the one involving mTOR goes through many steps to accomplish its duties. The different steps form a cascade that can ramp the signal up or down, depending on the conditions of the cells or tissues. These kinase cascades are embedded within complicated feedback loops, such as the one activated by rapamycin.

Research on the mTOR pathway is of increasing interest to drug companies, Shokat said.

Since mTOR acts “upstream” and “downstream” of other key kinases that are found to cause cancer– such as the much-studied kinases PI3K and Akt– he thinks blocking it will short-circuit the many feedback loops cancer cells use to generate and maintain a growth signal.

“We are extremely excited about the potential of targeting mTOR in this way to treat a number of cancers, although we are aware that there are many hurdles to reaching the finish line,” Shokat said.

Lead author on the paper is Morris E. Feldman, a graduate student in Shokat’s lab.

Shokat’s colleague, Davide Ruggero, PhD, who studies cancer’s effect on protein synthesis, is also a coauthor. Ruggero is assistant professor of urology in the UCSF Helen Family Comprehensive Cancer Center. Other coauthors are Beth Apsel, PhD, a graduate student in chemistry and chemical biology; and Zachary Knight, PhD, a postdoctoral scientist in Shokat’s lab during the research project. Also: Aino Uotila and Robbie Loewith in the department of molecular biology, University of Geneva.

The research was funded by the Howard Hughes Medical Institute.

The private company co-founded by Shokat is called Intellikine. He is the chairman of its scientific advisory board and holds stock options in the company.

Drug Discovery Short-circuits Cancer Growth