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

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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 – NYTimes.com

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In typical breast cancers, the tumor forms a lump that a person can feel or see on a mammogram. In the inflammatory kind, which makes up 1 to 2 percent of the roughly 180,000 new breast cancer cases per year, the cancer “is often not a mass,” says Dr. Eric Winer, chief of the Division of Women’s Cancers at Dana-Farber Cancer Institute. “Instead, the breast is often warm, red, swollen and tender.” The cancer is often misdiagnosed as an infection treatable by antibiotics.

The cancer moves so quickly “that the breast can become noticeably larger in just a few weeks,” says Dr. Barbara Smith, director of the breast program at Massachusetts General Hospital. What makes the cancer so dangerous, she says, is that it grows in the lymphatic vessels, “the highways out of the breast to the rest of the body.” Immediate treatment is essential.

Women with inflammatory cancer get chemotherapy first to get rid of cancer cells that have spread to the rest of the body, then surgery and radiation.

A potent drug called Herceptin can also be used.

Two years ago, the M.D. Anderson Cancer Center in Texas became the first clinic in the world to open a specialized program for inflammatory breast cancer. Other centers, including Dana-Farber, are developing such programs.

Because care is specialized, doctors advise women to seek treatment at major medical centers.

What is inflammatory breast cancer and is it worse than regular breast cancer?

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Yes — but only the 20% to 30% of breast cancers that express the HER2 molecules, suggest studies by Javier A. Menendez, PhD, at the Catalan Institute of Oncology in Girona, Spain, and colleagues.

The Spanish researchers wondered why some studies show that the olive-oil-rich Mediterranean diet cuts breast cancer risk while other studies do not. They theorized that the active compounds in olive oil only affect certain cancers.

The breast cancer drug Herceptin targets the HER2 molecule on tumor cells. Could olive oil compounds have the same target?

Menendez’s team first isolated various compounds from EVOO — which, because it is made without heat, keeps most of the olive compounds that are lost in more processed, lower quality olive oils.

They found that two types of these compounds, secoiridoids and lignans, killed off HER2-positive human breast cancer cells but had little effect on HER2-negative cells.

They also found that when they fed large amounts of EVOO to rats with carcinogen-induced breast cancers, the animals’ tumors became less malignant.

But this does not mean that eating a lot of EVOO will prevent or treat breast cancer.

“Extreme caution must be applied” in interpreting their findings, Menendez and colleagues warn.

One class of EVOO anticancer compounds, the secoiridoids, “rapidly split into inactive compounds” when eaten. These compounds likely won’t help if eaten, but could be a starting point for development of new breast cancer drugs.

On the other hand, the lignan compounds “may represent a different molecular scenario,” Menendez and colleagues suggest. In mouse-feeding studies, tumor tissues accumulate lignans, “thus suggesting that the anti-cancer activity of lignans may be due to their direct local effects on the breast cancer tissues.”

A recent study suggested that eating flaxseed is beneficial to women with newly diagnosed breast cancer. Flaxseed has high lignan concentrations.

Even so, Menendez and colleagues note that much more study will be needed before doctors can recommend EVOO for breast cancer prevention or treatment.

Extra Virgin Olive Oil vs. Breast Cancer

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“Most young women at risk of breast cancer following chest radiation for a pediatric cancer, including women at highest risk (Hodgkin lymphoma survivors), are not being appropriately screened,” Kevin C. Oeffinger, MD, of Memorial Sloan-Kettering Cancer Center in New York, and colleagues write.

About 20,000 to 25,000 women 25 and older in the U.S. have received chest radiation for a childhood cancer, according to background information in the journal report. For the past decade, experts have recommended yearly screening mammograms for women who received moderate- to high-dose chest radiation beginning either at age 25 or eight years after the treatment, whichever occurs last.

In 2008, the Children’s Oncology Group (COG) updated the guidelines to include breast magnetic resonance imaging (MRI) along with yearly mammograms. The American Cancer Society recommends the same.

But some women in the new study had never even had a mammogram.

About 12% to 20% of women who receive moderate- to high-dose chest radiation for a childhood cancer will be diagnosed with breast cancer by age 45, but some develop the disease much earlier. “The risk of breast cancer begins to increase as early as 8 years after radiation and the [midpoint] age of breast cancer diagnosis ranges from 32 to 35 years,” Oeffinger’s team writes.

Oeffinger and colleagues based their findings on a 114-item questionnaire filled out by 625 female participants, aged 25 to 50, of the Childhood Cancer Survivors Study (CCSS). All the women had survived childhood cancer and had been treated with chest radiation.

The researchers compared the women’s responses to similarly aged childhood cancer survivors who did not receive chest radiation, and siblings with no history of childhood cancer.

Among women 25 to 39 who had received chest radiation for childhood cancer:

* Most (47.3%) never had a mammogram.
* 63.5% had not received a screening mammogram within the past two years, despite guidelines that recommend annual exams.
* Less than a fourth (23.3%) had a screening or diagnostic mammogram in the previous year.
* They were three times more likely to have had a mammogram if their doctor recommended one.

Among women 40 to 50 who had received chest radiation for childhood cancer:

* They were more likely to have had mammograms than those aged 25 to 39.
* About two-thirds (76.5%) had a screening mammogram in the past two years (compared with 70% for women who did not receive chest radiation during childhood and 67% for siblings without history of childhood cancer).
* Slightly more than half (52%) had regular breast cancer screenings. (This finding was not significantly higher than those who never had chest radiation.)

Many Childhood Cancer Survivors Skip Breast Cancer Screenings

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Breast tumors in men are usually palpable by the time they’re discovered or they show signs “such as change in overlying skin or nipple,” Dr. Wei-Tse Yang told Reuters Health.

“Be attentive to any palpable masses in men and obtain imaging evaluation early,” he advises doctors.

In their report, Yang from The University of Texas M. D. Anderson Cancer Center, Houston, and colleagues describe the appearance of male breast tumors as seen on a mammogram or by ultrasound.

Among 244 men with breast cancer, only 57 underwent preoperative mammography or sonography, and that was because of clear signs of a problem: 54 had a palpable mass and two had nipple inversion or nipple discharge.

In a third of the cases, mammography showed a calcified mass, which is often considered to be benign.

“Radiologists should be aware of these findings to avoid the misdiagnosis of cancer in men as a benign lesion,” the investigators say.

Breast cancer in men often detected late | Health | Reuters

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The researchers compared about 2,000 Norwegian women ages 50 to 64 who either had screening mammography three times in four years or just one mammogram at the end of the four-year study. The frequently screened group had 22 percent more breast cancers diagnosed compared with the one-time-only group, which could mean that some of the tumors detected initially in the first group would have regressed had they not been spotted. “The hypothesis suggests that about 20 percent of the women in the multiple screen group received unnecessary treatment because the tumors would have disappeared on their own,” write the authors of an editorial that accompanied the article.

If doctors can eventually figure out which cancers will disappear on their own—something the new study doesn’t do—the discovery could be a great boon for patients. But for now, it’s very troubling when one considers how many women may needlessly go through the awful downsides of treatment, including balding, nausea, and early menopause—to say nothing of the disfiguring surgery that can destroy a woman’s body image.

On the other hand, mammograms have been shown to lower your risk of dying from breast cancer by 20 to 35 percent (depending on which study you look at) if you’re over 50 and by up to 20 percent if you’re between 40 and 50.

So, what are you supposed to do?

“At the moment, nothing different,” says Susan Love, a clinical professor of surgery at the University of California-Los Angeles medical school and president of the Dr. Susan Love Research Foundation, which focuses on breast cancer. “I think this study does show that some cancers do regress, but that doesn’t say to us that mammograms are no good.”

What it does indicate is that breast cancer may be like prostate cancer—many men develop prostate cancers that would never wind up killing them. Perhaps some breast cancers found on mammograms can be simply monitored every year with mammograms, ultrasound, or MRI to see if they progress—a type of “watchful waiting” approach now taken with many older prostate cancer patients. “But we’re not there yet,” Love says. “We need to do studies first to see which cancers we don’t need to worry about.”

Scientists are already starting to use genetic tests like MammaPrint to determine the superbad breast cancers—the ones most likely to spread everywhere—that call for total destruction with chemotherapy. They’ve also identified a type of breast tumor called the “almost normal” kind that usually stays put and behaves itself. “I wouldn’t be surprised if this particular type was the one that disappeared on its own,” says Love. But, at the moment, this is just a hunch. Until researchers know more about these apparently harmless cancers, women over 40 should keep on getting those regular mammograms and the full course of treatment for any breast cancer.

On Women (usnews.com)

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University of California at San Diego scientists, working with Korean researchers, used bioinformatic algorithms to identify these subnetworks. They then mapped the gene activity to the many networks of signaling pathways and protein complexes that prior research had found in human cells.

The scientists explained that conventional “rapid microarray” technology allows cancers to be classified by gene expression, or activity patterns, but this system is imprecise because cells from a single tumor sample can have genes switched on in some cells (from one part of the tumor) that are inactive elsewhere.

The researchers’ new work enabled them to identify subnetworks in which aggregate gene expression patterns can distinguish between patient groups.

They also uncovered many genes associated with breast cancer that had not been identified by previous gene microarray profiles.

The researcher team is now applying its analysis system to other cancers. These insights could give doctors a new tool for diagnosis and prognosis, they say.

The findings are scheduled to be presented Monday at the American Society for Cell Biology’s annual meeting, in San Francisco.

US News and World Report

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Public health researcher Lisa Lines of the consulting firm Boston Health Economics in Waltham, Mass., and her colleagues analyzed expenditures made by 806 breast cancer patients from 1996 to 2005. Out-of-pocket costs included insurance premiums, payments to meet deductibles, co-pays and any other payments made to meet medical or drug costs associated with treatment.

The average annual out-of-pocket expenditure was about $2,300 per breast cancer patient, about half of which was spent on prescription drugs.

“Breast cancer is actually not the most expensive cancer for out-of-pocket expenditures,” Lines says. This and other data suggest that breast cancer costs patients more than colon or prostate cancer, but less than lung cancer, she says.

But breast cancer has a large proportion of people with a “high burden,” she says. The researchers classified patients as having a high burden when their out-of-pocket costs for coping with the cancer exceeded 10 percent of the family’s income. Roughly 70 percent of low-income breast cancer patients fell into the high-burden category in this analysis, compared with about 15 percent of middle-income and less than 5 percent of high-income breast cancer patients — apparently the result of better insurance, she says.

Cancer patients in general are disproportionately affected by a high out-of-pocket burden. That’s because many cancers have come to be treated more like a chronic disease than they used to be and are treated on an outpatient basis, Lines says. In the past, most cancer patients were treated in hospitals, where major medical insurance covered much of the cost.

Science News

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Even women who took estrogen and progestin pills for as little as a couple of years had a greater chance of getting cancer. And when they stopped taking them, their odds quickly improved, returning to a normal risk level roughly two years after quitting.

Collectively, these new findings are likely to end any doubt that the risks outweigh the benefits for most women.

It is clear that breast cancer rates plunged in recent years mainly because millions of women quit hormone therapy and fewer newly menopausal women started on it, said the study’s leader, Dr. Rowan Chlebowski of Harbor-UCLA Medical Center in Los Angeles.

“It’s an excellent message for women: You can still diminish risk (by quitting), even if you’ve been on hormones for a long time,” said Dr. Claudine Isaacs of Georgetown University’s Lombardi Comprehensive Cancer Center. “It’s not like smoking where you have to wait 10 or 15 years for the risk to come down.”

Study results were given Saturday at the San Antonio Breast Cancer Symposium.

They are from the Women’s Health Initiative, which tested estrogen and progestin pills that doctors long believed would prevent heart disease, bone loss and many other problems in women after menopause. The main part of the study was stopped in 2002 when researchers saw surprisingly higher risks of heart problems and breast cancer in hormone users.

Since then, experts have debated whether these risks apply to women who start on hormones when they enter menopause, usually in their 50s, and take them for shorter periods of time. Most of the women in the federal study were in their 60s and well past menopause.

So the advice has been to use hormones only if symptoms like hot flashes are severe, and at the lowest dose and shortest time possible. The new study sharpens that message, Chlebowski said.

“It does change the balance” on whether to start on treatment at all, he said.

Even so, most women will not get breast cancer by taking the pills short-term. The increased cancer risk from a couple of years of hormone use translates to a few extra cases of breast cancer a year for every 1,000 women on hormones. This risk accumulates with each year of use, though.

The Women’s Health Initiative study had two parts. In one, 16,608 women closely matched for age, weight and other health factors were randomly assigned to take either Wyeth Pharmaceuticals’ Prempro — estrogen and progestin — or dummy pills.

This part was halted when researchers saw a 26 percent higher risk of breast cancer in those on Prempro.

But that was an average over the 5 1/2 years women were on the pills. For the new study, researchers tracked 15,387 of these women through July 2005, and plotted breast cancer cases as they occurred over time.

They saw a clear trend: Risk rose with the start of use, peaked when the study ended and fell as nearly all hormone users stopped taking their pills. At the peak, the breast cancer risk for pill takers was twice that of the others.

Think of it as President Bush’s public approval rating, said another study leader, Dr. Peter Ravdin of the University of Texas M.D. Anderson Cancer Center in Houston.

“Bush’s popularity may be 50 percent on average, but it might have been descending the whole time he was president,” Ravdin said.

In the second part of the federal study, researchers observed just 16,121 women who had already been on hormones for an average of seven years and another group of 25,328 women who had never used them. No results on breast cancer risk in these women have been given until now.

Plotting cases over time, researchers saw in retrospect that hormone users had started out with twice the risk of breast cancer as the others, and it fell as use declined. Among those taking hormones at the start of the study, use dropped to 41 percent in 2003, the year after the main results made news.

In the general population, use of hormone products has dropped 70 percent since the study, said another of its leaders, Dr. JoAnn Manson, preventive medicine chief at Harvard’s Brigham and Women’s Hospital in Boston.

That corresponds with big drops in breast cancer cases, but some scientists have said this could be due to a fall-off in mammograms, which would mean fewer cancers were being detected, not necessarily that fewer were occurring.

The new study puts that theory to rest. Mammography rates were virtually the same among those taking hormones and those not.

“It is clear that changing mammography patterns cannot explain the dramatic reductions in breast cancer risk,” Manson said.

“The data are getting stronger,” said Dr. C. Kent Osborne, a breast cancer specialist at Baylor College of Medicine in Houston.

Women who do need the pills should not panic, though the doubling of risk — a 100 percent increase — for long-term users is quite worrisome, cancer specialists say. Although the new study does not calculate risks in terms of actual cases, previous research showed that the average increased risk of 26 percent meant a difference of a few extra cases a year for every 1,000 women on hormone pills, compared with nonusers.

“Hormone therapy remains a good health care choice to relieve moderate to severe menopausal symptoms,” says a statement from Wyeth, which made the pills used in the study.

“Most women should be able to discontinue hormones in three to four years,” or at least reduce their dose, Manson said.

A future analysis will look at other women in the study who took only estrogen, generally women who have had hysterectomies.

The Associated Press:

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