Sunday, December 27, 2009

Answering breast cancer

That's what Sean Halpin was aiming for when the auto industry designer set out to make prosthetic breasts for women who've gone through mastectomies but who didn't -- or couldn't -- have breast reconstruction.

Inspired by the death of his parents from cancer, Halpin used his talents in design and plastic molding to help others with the disease.

He founded Proud Mary Prosthetics a little over a year ago and began selling the silicone prostheses this year in stores in Michigan and a few other states. He hopes to ramp up production and begin hiring more workers soon.

Halpin was already an entrepreneur. He has owned his own auto design business for 15 years, including Halpin Design, which he began in 2001.

Born in Troy, he earned a master's degree in manufacturing at the University of California-Los Angeles and worked in the aerospace industry in the 1980s.

In the early 1990s, he returned to Michigan to help his parents and ended up working on General Motors' newly launched Saturn operations. He eventually founded his own business.

His company -- Halpin Design -- works with suppliers and automakers, helping interpret what the engineers and designers want on a project. His company has also done work for Fisker Automotive and Chrysler. In general terms, his team takes a designer's work -- perhaps through a clay model -- and translates it into technical terms for engineers to build the product.

"I can be at almost any intersection and see someone ... pulling a steering wheel or pushing buttons on an instrument panel that we did," Halpin said.

As the economy began to darken, Halpin felt the company needed to diversify.

Teresa Heinz undergoes surgery for breast cancer

Teresa Heinz, 71, the widow of Sen. John Heinz, heir to the Heinz ketchup fortune, is reportedly receiving treatments for her breast cancer.

Heinz, wife of Sen. John Kerry, the 2004 Democratic presidential nominee, underwent lumpectomies on both breasts at Massachusetts General Hospital in early October after she found out that she had cancer in her left breast.

Heinz will receive radiotherapy in January 2010. But she has not decided whether she is going to undergo any chemotherapy even though the treatment doctors claim would raise her survival odds to 99 percent, given her age and the side effects of the treatment.

Breast cancer is diagnosed in more than 170,000 women each year in the United States and the disease kills about 50,000 annually.

Women in the United States where the cancer incidence is much higher than poor countries are advised to receive the mammogram screening starting age 40. But the U.S. Preventive Services Task Force recommended last month that women should start receiving this screening at age 50 to reduce both the medical cost and side effects of the procedure.

Medical groups and many breast cancer survivors oppose the recommendations saying mammogram screenings save life.

Studies have shown that mammogram screenings can find most cases of breast cancer for sure. But there are some problems. First, the procedure may result in false negative cases. Second, it can result in false positive cases which will lead to further biopsies and damaging breast tissue. Third, the procedure cannot reduce the cancer mortality as the current treatments can't help much in many cases of aggressive breast cancer and patients die no matter how early the disease is found.

Saturday, December 26, 2009

Recommendations for cancer screening are under review

You'd think there could be no downside to widespread screening for cancer. But that's not always the case. Studies on Pap smears, for example, show that atypical cells can disappear if they're left alone, while interventions can cause scarring and interfere with later fertility. And many prostate cancers are so slow-growing that they won't affect a man's health, whereas cancer treatments come with adverse health effects.

Faced with the pluses and minuses, doctors often don't agree on how to screen for cancer. "Organizations send us their guidelines hoping for our endorsement," says Dr. Doug Campos-Outcalt, who heads the development of clinical practice guidelines for the American Academy of Family Physicians, an organization representing about 94,000 primary-care doctors. Those guidelines, he notes, are frequently in conflict with one another.

The American Academy of Family Physicians, for its part, tends to follow the recommendations of the U.S. Preventive Services Task Force, the group that recently advised against routine mammograms for women in their 40s. Why? Because compared with advocacy groups or specialists organizations, the task force has a far superior guideline development process that is evidence-based, not experience-based, Campos-Outcalt says.

"Evidence-based methodology is the best," he says. "The least dependable method -- and the most likely to change -- is current practice and expert opinion."

Here's a closer look at current recommendations for breast, cervical, colorectal and prostate cancer.

Breast Cancer

Screening test: Mammogram.

Recommendation: Women ages 40 and older should be screened annually, says the American Cancer Society. The American Academy of Family Physicians says every one to two years, and the American College of Obstetricians and Gynecologists says every one to two years before age 50, and annually after that.

Cost: ranges from $90 to $150, according to Medicare and California Health Benefits Review Program.

Number of people one needs to screen to save one life:2,000 women, according to a 2009 review by the Cochrane Collaboration, an international group of experts that reviews clinical trial evidence. The recent U.S. Preventive Services Task Force analysis broke it down by age group: 1,904 women ages 40 to 49 and 1,339 women ages 50 and older.

Adverse effects: Unnecessary biopsies or diagnosing abnormalities as aggressive cancer when they're not can lead to unnecessary treatment with surgery, radiation or drugs.

Proposed changes, if any: Women ages 50 to 75 should get screened every other year and women ages 40 to 49 should not be routinely screened, according to the U.S. Preventive Services Task Force.

Special cases: Women at higher risk for breast cancer -- such as those with a mother, sister or daughter having had breast cancer, or who began menstruating before 12, or haven't borne children until age 30 (or not at all) or who have had previous breast abnormalities -- should consider getting screened in their 40s.

Teresa Heinz fighting breast cancer

Teresa Heinz, a part-time Wood River Valley resident for more than 30 years, has announced that she is being treated for breast cancer, but has a 95 percent chance of recovery.

Heinz, 71, and her husband, Massachusetts Sen. John Kerry, the 2004 Democratic presidential nominee, own a house just north of Ketchum along the Big Wood River.

On Wednesday, Heinz—the widow of Sen. John Heinz, heir to the Heinz ketchup fortune—told the Associated Press that she found out in late September that she had cancer in her left breast after having her annual mammogram.

In early October, she underwent lumpectomies on both breasts at a Washington hospital after doctors also discovered what they thought was a benign growth on her right breast.

That diagnosis was initially confirmed in post-operative pathology, but two other doctors later found it to be malignant. In November, Heinz had another pair of lumpectomies performed at Massachusetts General Hospital.

Thursday, December 17, 2009

Beer warding off prostate cancer

An ingredient of beer may someday help ward off prostate cancer, new animal experiments suggest.

The compound in question, xanthohumol, is found in hops — the bitter flavoring agent in beer — and is known to block the male hormone testosterone, which plays a role in the development of prostate cancer.

“We hope that one day we can demonstrate that xanthohumol prevents prostate cancer development, first in animal models and then in humans, but we are just at the beginning,” said lead researcher Clarissa Gerhauser, group leader of cancer chemoprevention in the division of epigenomics and cancer risk factors at the German Cancer Research Center in Heidelberg.
HRT news

The incidence of breast cancer in the United States declined 7 percent between 2002 and 2003, but only part of that decrease can be attributed to reduced use of hormone replacement therapy by menopausal women, researchers say.

HRT use declined after the 2002 release of The Women's Health Initiative study, which concluded that hormone therapy increases the risk of breast cancer. Other studies have confirmed the link.

“We found that the change in hormone therapy use only accounted for a decline (in breast cancer) of about 3 percent, so there's another 4 percent that is being caused by something we do not yet know,” study leader Brian Sprague said in a news release.

Further research is needed to identify the other reasons for the decrease in breast cancer cases, Sprague said.

Scientists unlock genetic code in major cancer breakthrough

The entire genetic codes of two common types of cancer have been cracked, according to scientists, who say the breakthrough could unlock a new era in the treatment of deadly diseases.

Scientists at the UK-based Wellcome Trust Sanger Institute catalogued the genetic maps of skin and lung cancer and have pinpointed the specific mutations within DNA that can lead to dangerous tumors.

Researchers predict these maps will offer patients a personalized treatment option that ranges from earlier detection to the types of medication used to treat cancer.

The genetic maps will also allow cancer researchers to study cells with defective DNA and produce more powerful drugs to fight the errors, according to the the study's scientists.

"The knowledge we extract over the next few years will have major implications for treatment," Peter Campbell from the Wellcome Trust Sanger Institute said.

"By identifying all the cancer genes we will be able to develop new drugs that target the specific mutated genes and work out which patients will benefit from these novel treatments."

Scientists found that the DNA code for skin cancer contained nearly 30,000 errors and lung cancer DNA contained more than 23,000.

"These are the two main cancers in the developed world for which we know the primary exposure," Mike Stratton, from the Cancer Genome Project said.

Wednesday, December 16, 2009

Oncotype Dx® Predicts Chemotherapy Benefit in Node-positive Breast Cancer

Researchers affiliated with The Breast Cancer Intergroup of North America have reported that the Oncotype Dx® test identifies a subset of women with node-positive, hormone receptor-positive breast cancer who do not appear to benefit from adjuvant anthracycline-based chemotherapy. The details of this retrospective analysis of a randomized trial were presented at the 2009 San Antonio Breast Cancer Symposium and were also published early online on December 19, 2009 in Lancet Oncology.

Oncotype Dx is a genomic test that previously has been shown to predict the likelihood of cancer recurrence in women with early-stage, estrogen receptor-positive breast cancer that is treated with hormonal therapy. Women with a low risk of recurrence derive little benefit from chemotherapy. Oncotype Dx evaluates 21 genes from a sample of the patient’s cancer to determine the patient’s Recurrence Score. The Recurrence Score ranges from 0 to 100, with a higher score indicating a greater risk of recurrence. Oncotype Dx has been added to U.S. medical guidelines for early-stage breast cancer.

Oncotype Dx was initially validated among women with node-negative breast cancer, but the test also appears to provide important information about women with node-positive breast cancer. To further assess the test among women with node-positive, hormone receptor-positive breast cancer, researchers evaluated information from 367 patients. One-hundred forty-eight patients received adjuvant therapy with tamoxifen [Nolvadex®] alone (T), and 219 received tamoxifen plus cyclophosphamide, doxorubicin and 5-FU (CAF-T). Patients were divided into groups based on nodal status (1-3 or 4+T).

* Statistically significant breast cancer specific survival (BCSS) was not observed in CAF-T treated patients with low (<18)>31) Recurrence Score.
* The 10-year BCSSs were 92% for T and 87% for CAF-T for women with a low Recurrence Score.
* The 10-year BCSSs were 70% for T and 81% for CAF-T for women with an intermediate Recurrence Score.
* The 10-year BCSSs were 54% for T and 73% for CAF-T for women with a high Recurrence Score.
* These results were similar for women with one three or four or more positive lymph nodes.

Comments: These results suggest that anthracycline-based chemotherapy may not benefit women with node-positive, hormone receptor-positive breast cancer and a low Oncotype Dx Recurrence Score. For patients with an intermediate Recurrence Score, the trend was for a benefit from CAF. A prospective study is proposed to confirm these findings. In addition, currently used taxane-based adjuvant regimens may yield the same results as CAF.

References:

Albain KS, Barlow WE, Shak S et al. Prediction of 10-year chemotherapy benefit and breast cancer-specific survival by the 21-gene Recurrence Score (RS) assay in node-positive, ER-positive breast cancer—An update of SWOG-8814 (INT0100). Presented at the 32nd CTRC-AACR San Antonio Breast Cancer Symposium. December 9-13, 2009. San Antonio, TX. Abstract 112.

Albain KS, Barlow WE, Shak S et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised clinical trial. Lancet Oncology [early online publication].

Can we diagnose and destroy cancer in one sitting?

Let's say you find a lump somewhere and decide to go in for an exam. And let's say there was a little box to check that allows you to get a shot that targets and kills cancerous cells right then and there, no surgery, no waiting, and possibly no radiation or chemo therapy down the road. Would you check the box?

Since time matters when it comes to cancer, the creation of a single nanoparticle--traceable in real time via MRI--that tags and zaps cancer cells all in one procedure has a team of researchers raising their eyebrows in hopeful arches.

"Some of the most essential questions in nanomedicine today are about biodistribution--where particles go inside the body and how they get there," says Naomi Halas, a nanomedicine pioneer at Rice University in Houstin, Texas, whose findings have just been published in Advanced Functional Materials. "Noninvasive tests for biodistribution will be enormously useful on the path to FDA approval, and this technique--adding MRI functionality to the particle you're testing and using for therapy--is a very promising way of doing this."

The all-in-one particles are modeled on nanoshells, a cancer treatment Halas invented in the '90s that are now in human clinical trials. The shells harvest laser light that would typically pass through the body harmlessly and convert that light into heat that destroys cancerous cells.

Breast cancer treatment must be affordable

October was breast cancer awareness month, and I received well over 10 telephone calls asking for donations to cancer research. As I am a 16-year breast cancer survivor, I tell these callers that they are preaching to the choir.
But more important than money for research is money to help uninsured women pay for the cost of treatment. Not every woman is as fortunate as I was.

What good is it for a woman to be vigilant about mammograms and checkups if the result of this vigilance reveals breast cancer and she is unable to pay for treatment?

Cancer diagnosis increases the risk of suicide and cardiovascular disease

Men who have recently been diagnosed with prostate cancer are at greater risk of committing suicide and developing and dying from cardiovascular disease, reveals a study from Karolinska Institutet published in the open scientific journal PLoS Medicine.

“Cardiovascular disease and suicide can be viewed as a manifestation of exceptional psychological stress,” says Katja Fall, one of the researchers behind the study. “The study results offer some indication of the mental suffering in this group of patients, particularly around the time of diagnosis.”

The study is based on register information on almost 170,000 Swedish men who were diagnosed with prostate cancer between 1961 and 2004, of whom a very small proportion committed suicide in connection with their diagnosis. However, compared to men without prostate cancer, the risk of committing suicide was increased eightfold during the first week after diagnosis, and almost threefold during the first year.

Men who were diagnosed with prostate cancer before 1987 were 11 times more likely to die of cardiovascular disease during the first week after diagnosis, while the risk was twice as high during the first year as for men without prostate cancer.

After 1987 the combined risk of hospitalisation or death as a result of cardiovascular disease was increased threefold during the first week after diagnosis, and was slightly higher during the first year. Although it is not known why the risk was greater before 1987, the researchers believe that it may be due to less developed cardiovascular care combined with the fact that more men were diagnosed with more advanced prostate cancer and had a more negative attitude to the diagnosis.

The risk of both dying from cardiovascular disease and committing suicide was higher among young men than older men, which may be because young men have a greater sense of potential loss of different aspects of their lives.

“Our hypothesis is that the emotional stress that goes with a prostate cancer diagnosis can itself have a negative impact on patients health,” says Fall. “This should be noted by staff who deal with the increasing number of men who are diagnosed with prostate cancer each year.”

Targeted Breast Cancer Drug Shrinks Tumors

A new targeted cancer drug has been shown to shrink tumors in women with metastatic breast cancer after an average of seven other drugs, including Herceptin, failed.

The new drug, called T-DM1, combines Herceptin with a potent chemotherapy drug. It's a Trojan horse approach, where Herceptin homes in on cancer cells and delivers the cancer-killing agent directly to its target.

Tumors shrank in one-third of women with metastatic breast cancer given T-DM1, says Ian Krop, MD, of the Dana-Farber Cancer Institute in Boston. In another 12%, tumors stopped growing for at least six months.

The women remained cancer-free for an average of seven months -- results unheard of in patients this sick, he says.

All the women, who had breast tumors for an average of three years, had cancer that had metastasized, or spread to other parts of the body. They had been treated with an average of seven different therapies, including Herceptin, Tykerb, and Xeloda, and each had failed.

"This is the first study looking at women who have failed so many other treatments," Krop tells WebMD. "But we think these results are as good as we've ever seen is such a refractory [sick] population," he says.

The findings were presented at the San Antonio Breast Cancer Symposium.

Monday, December 14, 2009

Join the fight to conquer leukemia

When I first encountered Kareem Abdul-Jabbar, he was Lew Alcindor. That was in March of 1967, when UCLA’s basketball team arrived in Freedom Hall for the NCAA Final Four. There’s no way I could have guessed that, more than four decades later, he and I would become blood brothers. But, in a sense, that’s now what we are. We both have leukemia.We’re an odd couple, Jabbar and I. He’s the 7-foot-1 ex-basketball player who led UCLA to three straight NCAA basketball titles before going on to become the leading scorer in pro basketball history, and I’m one of the many scribes who tried, mostly in vain, to adequately describe his elegant presence on the court.

He grew up in New York City, me in Kentucky. He’s African-American, I’m white. He likes jazz, I prefer oldies rock n’ roll. It just goes to prove, I suppose, that leukemia is an equal-opportunity disease.

From what I’ve read, Jabbar was shaken when he was told that he had Chronic Myeloid Leukemia (CML). “I was scared,” he said. “I thought it could mean I have a month to live.” I know the feeling. That’s exactly how I felt 3 ½ years ago when I was told that I had developed Chronic Lymphocytic Leukemia (CLL).

Our diseases are different because of the types of white blood cells that are spreading. But they’re alike in that both are incurable and fatal, both generally strike people past the age of 55 (I’m 66, Jabbar 62), and both spread slowly. We both are far luckier than former Syracuse football star Ernie Davis, who became the first African-American to win the Heisman Trophy in 1961. He was diagnosed with Acute Myeloid Leukemia (AML) in the summer of 1962 and died nine months later.

Both Jabbar and I have been told that, with proper monitoring and medication, we can reasonably expect to live out our days without making significant lifestyle changes. Nevertheless, our forms of cancer are not to be taken lightly. Ed Bradley, the pioneer African-American reporter for CBS News, died from CLL when he was 65.

All told, an estimated 35,000 Americans are diagnosed with one form of leukemia or another every year – and 22,000 eventually die of it. Researchers have tried to pinpoint a cause of leukemia, but so far have succeeded only in linking it to high doses of radiation and the chemical benzene. Treatments may include chemotherapy, radiation, and use of drugs to promote the body’s immune reaction to cancerous cells.

NMSU's lone toxicologist tries to find the rhythm of breast cancer

After new epidemiological research found an increased risk of breast cancer associated with altered sleep patterns, a New Mexico State University researcher decided to further investigate the 24-hour biological rhythm in breast cells.

Although he has submitted three different grant proposals for continued research on this pattern, known as a circadian rhythm, and its influence on hormone levels within cells, Aaron Rowland, assistant professor of toxicology in the NMSU Department of Chemistry and Biochemistry, said he has high hopes for the latest one, submitted to the U.S. Department of Defense in November for $75,000.

"Research suggests that each cell type exhibits a roughly 24-hour cycle which regulates important cellular functions like controlling hormone levels and cell fate," Rowland said. "So far, these rhythms have been demonstrated in a small number of isolated populations of human cells derived from peripheral tissues like bone, fat, skin and liver cells. But no one has yet to demonstrate the circadian rhythm in cultured breast cells, those grown in a laboratory dish."

Through the research, Rowland said he and his team hope to determine if disrupting these rhythms in cells plays a role in carcinogenesis -- the process of normal cells transforming into cancerous ones.

So, Rowland said, when women alter their sleep pattern and the circadian rhythm, like when working a night shift for example, it can put them at higher risk of breast cancer.

This disruption was recently acknowledged by the World Health Organization's International Agency for Research on Cancer as potentially carcinogenic to humans.

"It is possible that cellular changes in these rhythms alter the hormonal balance within cells, making them vulnerable," Rowland said. "There is some indication already that a hormone involved in regulating circadian rhythms, melatonin, influences estrogen signaling. And changes in estrogen signaling have been linked to some forms of breast cancer."

One aim of the research is to understand the signaling processes involved in the start and spread of these rhythms in cultured breast tissue cells. If Rowland can determine the basic processes that influence these rhythms, he will be able to understand the environmental factors that may influence them as well. This could lead to the development of pharmaceuticals to re-establish a healthy normal rhythm. Another aim is to examine the disruption and then determine if it is even related to carcinogenesis.

"If the process works in cultured cells, then there is the potential use of a rat model," Rowland said. That rat model belongs to co-investigator Todd Thompson, a researcher from the University of New Mexico. Rowland and Thompson submitted a grant proposal in October to the Cowboys for Cancer Selection Committee at the UNM Cancer Research and Treatment Center.

Rowland is preparing another grant proposal in collaboration with the former NMSU computer science department head, Desh Ranjan, to continue their work to understand and model circadian rhythms in human cell cultures. This collaborative effort is being prepared as one of the projects in the NMSU CREST Center for Bioinformatics and Computational Biology proposal. That proposal will be due in February. The $150,000 to $200,000-a-year grant will support circadian rhythm-related research conducted over a five-year period.

An important tool Rowland uses to conduct this research is called the Kronos Dio, a real-time luminescence machine that indirectly measures circadian rhythms by monitoring the radiance of uniquely tagged human cells in a culture dish.

"It's invaluable in examining circadian rhythms in cultured cells," Rowland said.

Bryant Gumbel Remains Positive After Having Tumor Removed From Lung

Bryant Gumbel Remains Positive After Having Tumor Removed From Lung

Bryant Gumbel Remains Positive After Having Tumor Removed From Lung

While filing in for Regis Philbinon on “Live With Regis And Kelly,” Bryant Gumbel revealed that he had a tumor surgically removed from his lung 2 months ago,

“It’s nothing to hide from,” Gumbel said. “They opened up my chest, they took out a malignant tumor, they took out part of my lung and they took out some other goodies.”

Gumbel, 61, was hoping to keep his medical issues private, but backstage, Ripa insisted Gumbel participate in a dance segment on the show. Gumbel told Ripa of his surgery and explained that darning was probably out of the question.

According to his doctors, “he’ll need “more treatment” to make sure all the cancerous cells have been eliminated.”

Even with the surgery, some aggressive cancer cells had escaped, “so I went through some treatment and it’s done now,” he said.

Gumbel said that he is seeing his surgeon next week. “I’m hoping they greenlight me to play golf again,” he said.

According to the American Cancer Society, lung cancer (both small cell and non-small cell) is the second most common cancer in both men (after prostate cancer) and women (after breast cancer). It accounts for about 15% of all new cancers.


Chemo plus tamoxifen beneficial for some breast cancer patients

While a landmark study by the Southwest Oncology Group (SWOG) claimed that chemotherapy combined with tamoxifen could be beneficial for postmenopausal breast cancer patients, another study has claimed that this may not be true for everyone.

The second study found that a multigene test on tumours could identify a subset of patients who may not benefit from that chemotherapy.

Both studies, led by Dr. Kathy Albain, of Loyola University Health System, are based on a randomised phase III clinical trial of 1,477 postmenopausal women.

All of the women had estrogen receptor-positive (ER+) breast cancer that had spread to the lymph nodes under the arm, known as the axillary lymph nodes.

All women in the trial got daily tamoxifen for up to five years, long the standard therapy for treating ER+ breast cancer, the most common form of the disease.

Estrogen latches on to receptors on these cancer cells and promotes tumour growth. Tamoxifen blocks those receptors, locking estrogen out.

Of the 1,477 women in the trial, 361 got only tamoxifen. The rest got tamoxifen plus a regimen of a three-drug chemotherapy treatment known as CAF (cyclophosphamide, Adriamycin, and 5-fluorouracil).

In the first paper, researchers saw long-term survival benefits for the women who received CAF chemotherapy. These women’s risk of dying or having a cancer recurrence was 24 percent lower than it was for women who had gottentamoxifen alone.

The team also found that those who got the chemotherapy before the tamoxifen did better than those who got both simultaneously.

The CAF group had higher overall survival rates as well.

“Ten years after the start of their treatment, 68 percent of women who received chemotherapy followed by tamoxifen were still alive, while only 60pc of women in the tamoxifen-only arm lived for at least ten years,” said Dr. William Barlow, who served as lead statistician on both studies.

Ipsen Establishes Optimal Biological Dose for BN83495 Steroid Sulphatase (STS) Inhibitor in ER-Positive Metastatic Breast Cancer

Ipsen (Paris:IPN) (Euronext: FR0010259150; IPN) today announced the preliminary results of a phase I trial in metastatic breast cancer with BN83495, Ipsen’s lead and first-in-class orally available irreversible steroid sulfatase (STS) inhibitor. In the course of the study, the optimal biological dose was determined as 40 mg once daily oral administration for future phase II trials in this indication.

Preliminary results were the subject of a poster (#4097) entitled “A Phase I Dose Escalation Study of Steroid Sulfastase Inhibitor BN83495 (STX64) in Postmenopausal Women with ER- Positive Breast Cancer” presented at the 32nd San Antonio Breast Cancer Symposium held from December 9 to December 13, 2009, in San Antonio (Texas, USA).

The compound is currently in further clinical development for advanced endometrial cancer (phase II) as well as in Phase I clinical evaluation for castrate resistant prostate cancer in North America.

Professor R. Charles Coombes, Imperial College, Clinical Professor, Division of Surgery, Oncology, Reproductive Biology and Anaesthetics London, UK, lead author of the poster said: "To date, four of the patients who received BN83495 had tumours that remained stable for at least 6 months. One of these had cutaneous metastases that improved after one month of treatment. This is very encouraging, as these women are patients who are reaching the end of their hormonal treatment options. Importantly, BN83495 was well tolerated at the selected dose.” He added: “I am confident that BN83495 will become a new hormonal option in the treatment of post-menopausal women with ER-positive metastatic breast cancer".

Stéphane Thiroloix, Executive Vice-President, Corporate Development commented: “Metastatic breast cancer clearly deserves R&D effort to identify new hormonal agents that can delay disease progression and prolong overall survival. Following this important clinical milestone, we look forward to progressing the global development of BN83495 in this indication and in other selected hormone-dependent cancer indications. ”

About the study Thirty-five post-menopausal women with estrogen receptor (ER) positive metastatic breast cancer, having already received one or two different types of hormonal therapy for their disease, were treated with increasing doses of BN83495 given orally once daily.

Key findings are:

  • The primary endpoint of determining the optimal biological dose (OBD) was met. It was established as being once daily oral 40 mg. This dose will be used for future phase II trials in this indication.
  • An almost complete (95%) inhibition of the target enzyme (STS) was achieved in peripheral blood mononuclear cells at the 40 mg dose level. Thus, it resulted in a decrease of circulating steroid hormones.
  • BN83495 was well-tolerated with no Grade 3 or higher toxicity observed during the first 28 days of treatment.
  • Four patients in the three higher dose groups had stable disease > 6 months (according to RECIST criteria)

The trial presented at SABCS is ongoing and is being conducted in five centres in France, Belgium and the UK. 15 additional patients are being enrolled to evaluate metabolic anti-tumour activity.

About BN83495 Ipsen’s lead oncology development candidate, BN83495, is a first-in-class orally available irreversible steroid sulfatase (STS) inhibitor. The steroid sulfatase pathway gives rise to oestrone and dehydroepiandrosterone (DHEA) that in turn produce oestradiol and androstenediol (Adiol) that can both stimulate the growth of hormone-dependent tumours.

About Metastatic Breast Cancer Breast cancer is the second most common form of cancer and the second leading cause of cancer death among American women. In 2009 in the USA, according to the American Cancer Society, an estimated 192,000 women will be diagnosed with breast cancer and approximately 40,000 will die from the disease. Approximately 75 percent of women with newly diagnosed metastatic breast cancer are ER+.

About SABCS The SABCS is one of the largest annual symposium in the world devoted to breast cancer research and physician education. The symposium provides an important venue for cancer experts to review the latest information on the experimental biology, etiology, prevention, diagnosis and therapy of breast cancer and premalignant disease.

About Ipsen Ipsen is an innovation-driven global specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,200. Its development strategy is based on a combination of specialty medicine, which is Ipsen's growth driver, in targeted therapeutic areas (oncology, endocrinology, neurology and haematology), and primary care products which contribute significantly to its research financing. The location of its four Research & Development centres (Paris, Boston, Barcelona, London) and its peptide and protein engineering platform give the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. More than 800 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. This strategy is also supported by an active policy of partnerships. In 2008, Research and Development expenditure was about €183 million, close to 19% of consolidated sales, which amounted to €971 million while total revenues exceeded €1 billion. Ipsen’s shares are traded on Segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150). Ipsen’s shares are eligible to the “Service de Règlement Différé” (“SRD”) and the Group is part of the SBF 120 index. For more information on Ipsen, visit our website at www.ipsen.com.

Ipsen Forward Looking Statement The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Notably, future currency fluctuations may negatively impact the profitability of the Group and its ability to reach its objectives. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favourable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.

Ipsen has revealed data

Ipsen has revealed data from a trial into its first-in-class orally available irreversible steroid sulfatase (STS) inhibitor.

The drug has been undergoing testing for the treatment of metastatic breast cancer and so far, four patients being administered the treatment have "remained stable" for at least the last six months, according to professor Charles Coombes of Imperial College, London.

He added that he is confident that BN83495 will emerge as a new hormonal option for the treatment of post-menopausal females suffering from the disease in the future.

Also commenting on the findings, Stephane Thiroloix, executive vice-president of corporate development at Ipsen, stated: "Following this important clinical milestone, we look forward to progressing the global development of BN83495 in this indication and in other selected hormone-dependent cancer indications."

Meanwhile, earlier this month, Ipsen and Roche revealed that a treatment they have collaborated on - taspoglutide - yielded a positive outcome during a clinical study.

Tell Congress and the president to support the Lung Cancer Mortality Act of 2009

Most people do not even know that lung cancer takes more lives than all the other major cancers combined. It will kill more than three times as many men as prostate cancer and nearly twice as many women as breast cancer.

Yet lung cancer receives only a small fraction of research funding.

All patients are stigmatized whether they smoked or not and no one seems to care that over 60% of new patients are former smokers or people who never smoked at all.

One in five women being diagnosed now with lung cancer have never smoked.

As a former smoker myself, I worry too much about lung cancer, and although I quit in my early 30's I still am at risk.

Cancer has touched our whole family when my mother died of Colo-Rectal cancer almost 2 years ago, and I can only imagine the untold suffering that is going on in so many households that have a loved one who has lung cancer.

Over 160,000 Americans will die this year alone from lung cancer! This is unacceptable, and with your help we can change this.

The Lung Cancer Mortality Reduction Act of 2009 needs to be enacted into law and a comprehensive lung cancer research program started as quickly as possible.

Please write the president and members of congress to vote for this act.