plus 3, BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in ... - TMCnet

BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in ... - TMCnet
Chemicals suspected in breast cancer - YAHOO!
European regulators give greenlight to Glaxo's kidney and breast cancer drugs - Washington Examiner
How to make the best decisions when at high risk for breast or ovarian ... - Genetic Engineering News

BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in ... - TMCnet

Posted: 22 Feb 2010 05:00 AM PST

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LINCOLNSHIRE, Ill. --(Business Wire)-- BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced additional positive safety data in its ongoing LibiGel Phase III clinical development program. For the second time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review, the DMC once again unanimously recommended continuation of the study as described in the FDA-agreed LibiGel safety study protocol, with no modifications.

BioSante reported that the DMC reviewed all unblinded adverse events in the safety study including all "serious adverse events" and all "adverse cardiovascular and breast cancer events" in almost 1,200 women-years of exposure. To date, there have been no deaths, only six adjudicated cardiovascular events and only four breast cancers reported. Therefore, in view of the DMC recommendation, the BioSante LibiGel Phase III development program will continue as planned. BioSante targets mid-2011 for submission to the FDA of a new drug application (NDA).

"Based on this second unblinded positive review by the DMC, we believe that our safety study ultimately will provide the safety data needed for our NDA submission and FDA approval of LibiGel," said Michael Snabes, M.D., Ph.D., BioSante's vice president of clinical development. "We have known, based on blinded data, and BioSante remains blinded, that the rates of cardiovascular and breast cancer events in the study continue to be significantly lower than expected in those women enrolled in the safety study, all of whom are at the higher end of cardiovascular risk for the intended population. If there was a negative effect of testosterone, the cardiovascular rates would be higher. This recommendation by the DMC supports our belief that LibiGel will be safe for the treatment of female sexual dysfunction (FSD) in post-menopausal women, our target patient population. This outcome represents another significant positive advance for our LibiGel clinical development program," Dr. Snabes continued.

"The DMC, which for the second time, reviewed the LibiGel safety data on an unblinded basis, confirms what we have learned from the blinded data, that LibiGel does not pose a safety risk to the women in the study," said Stephen M. Simes, BioSante's president and CEO. "A DMC can recommend continuing, changing or stopping a study and their main responsibility is to ensure that subjects recruited to the study are not exposed to unnecessary safety risks. Therefore, the DMC's recommendation to continue the LibiGel safety study unchanged is the best possible outcome of the DMC's second unblinded review of all adverse events. This is very good news for BioSante and for women since LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in surgically menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need, also referred to as female sexual dysfunction (FSD)." The Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that will enroll between 2,400 and 3,100 women, exposed to LibiGel or placebo for 12 months. An NDA can be submitted and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.

The LibiGel safety study is tracking a predefined list of cardiovascular events, in agreement with the FDA, including cardiovascular death, myocardial infarction and stroke, in women 50 years of age or older and suffering from at least two cardiovascular risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study.

In addition to the Phase III Cardiovascular and Breast Cancer Safety Study, BioSante is conducting two LibiGel Phase III efficacy trials. The Phase III efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement).

As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante's lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals (NASDAQ:TEVA) and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery. In addition, BioSante will seek opportunities for its GVAX cancer immunotherapies, 2A/Furin and other technologies. Additional information is available online at: www.biosantepharma.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as "will," "potential," "continue," "could," "should," "believe," "can," "intends," "plans," "expects" or the negative of these words or other words of similar meaning, or future dates, are forward-looking statements. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; BioSante's need for and ability to obtain additional financing; the effect of general business and economic conditions; and risks arising from BioSante's merger with Cell Genesys (News - Alert). More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its registration statement on Form S-4 filed in connection with the merger with Cell Genesys and BioSante's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. The information set forth in this news release speaks only as of the date hereof, and BioSante undertakes no obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.

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Chemicals suspected in breast cancer - YAHOO!

Posted: 20 Feb 2010 01:23 PM PST

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SAN DIEGO, California (AFP) – US experts called for toxicity tests on chemicals they suspect play a role in the development of breast cancer, a leading cause of death in American women.

"We're currently not identifying chemicals that could be contributing to the risk of breast cancer," said Megan Schwarzman, a physician and environmental health researcher at the University of California, Berkeley.

According to Schwarzman, only a handful of the more than 200 chemicals in the environment linked to mammary tumours in lab animals have been regulated by the US authorities "on the basis of their ability to cause breast cancer."

She was speaking at a major science gathering, the annual meeting of the American Association for the Advancement of Science in San Diego.

Schwarzman is part of a panel of experts set up last year to identify which chemicals cause breast cancer and to develop toxicity tests to identify them.

The Breast Cancer Chemical Policy Project is expected to submit a report to health authorities in April.

As the incidence of the most common invasive cancer in women has skyrocketed in a generation, a flurry of studies have looked into the role of chemicals in breast cancer.

Treatment and survival rates have improved, but scientists have been running to stand still when it comes to pinpointing what causes breast cancer, said panel member Sarah Janssen, a physician and scientist with the Natural Resources Defence Council.

"Although we've made great strides in improving treatment and breast cancer survival rates, really we don't know much about preventing breast cancer... and most of the causes are not well understood," she said, noting hypotheses that environmental exposure affects breast development and the risk of disease.

"People are exposed to dozens of chemicals in their daily activities and biomonitoring has detected hundreds of chemicals in the fetal cord blood, in breast milk, adult blood and urine."

Only around a quarter of more than 186,000 women diagnosed with breast cancer in 2005 were genetically predisposed to the disease, and other breast cancer risk factors, including the early onset puberty in girls, have been linked to chemicals.

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European regulators give greenlight to Glaxo's kidney and breast cancer drugs - Washington Examiner

Posted: 19 Feb 2010 07:27 AM PST

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LONDON — European regulators on Friday recommended GlaxoSmithKline PLC's kidney cancer drug Votrient for conditional marketing authorization and also backed the wider use of the company's breast cancer drug Tyverb.

Decisions by the European Medicines Agency are usually endorsed formally by the European Commission, the European Union's executive body, within a couple of months.

The conditional decision on Votrient, which is designed to treat advanced renal cell carcinoma, means that it will be reviewed by the EMA in a year. The agency has said it wants to see a comparison with Pfizer's Sutent.

The EMA said that Tyverb, which is sold as Tykerb in the United States, should be approved for use in combination with an aromatase inhibitor in some breast cancer patients.

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How to make the best decisions when at high risk for breast or ovarian cancer

EUREKALERT

Contact: Jill Maxick
publicity@prometheusbooks.com
800-853-7545
Prometheus Books

Patient/physician team walks you through the genetics, diagnosis and treatment

When she was forty-two, Joi Morris learned that she has a genetic mutation on a gene known as BRCA2. This meant that her risk of getting breast cancer could be as high as 84 percent by age seventy, and that her risk for ovarian cancer was also high. Compounding her risk was the fact that her mother had developed breast cancer in her forties. After much research and consultation, Joi made the difficult decision of undergoing prophylactic bilateral mastectomies.

When she first received her genetic test results, the vast knowledge needed to understand both her risk and her medical options was daunting and confusing. She yearned for answers to her many questions but there was no single, comprehensive source of information and advice to help guide her. POSITIVE RESULTS: MAKING THE BEST DECISIONS WHEN YOU'RE AT HIGH RISK FOR BREAST OR OVARIAN CANCER (Prometheus Books, $20) was born of Joi's desire to create such a resource for those women (and some men) like her who were fighting, facing, and fearing breast and ovarian cancer.

To create a thorough guidebook, Joi needed the help of a compassionate and experienced medical expert. Enter Dr. Ora Gordona medical geneticist, director of the Cedars-Sinai GenRisk Adult Genetics program, and Joi's doctor. Through clinical practice, teaching, and professional lectures, Dr. Gordon had come to the realization that the general public understood little about hereditary cancer risk, and that unfortunately many doctors advising these women and men often had incomplete information. She too felt a book was needed that would give women and men the basic vocabulary and tools for navigating cancer risk for themselves and their loved ones, as well as providing an invaluable resource for primary-care doctors. Together they have created a truly unique resource for families facing the specter of hereditary breast and ovarian cancer.

"The combination of a breast cancer patient and a physician-specialist in high risk breast and ovarian cancer syndromes as co-authors is an extremely powerful combination resulting in a true reference manual for a new generation of genetically guided treatments for hereditary breast and ovarian cancers," says Geoffrey S. Ginsburg, MD, PhD, director, Center for Genomic Medicine, Duke Institute for Genome Sciences & Policy, and author of Genomic and Personalized Medicine.

One part memoir, three parts "how to" manual, POSITIVE RESULTS is both Joi's account of navigating the decision-making maze as well as the helpful guidebook she so desperately wanted at the start of her journey. It comprehensively reviews every decision, beginning with genetic testing and genetic counseling; provides history and perspective on breast and ovarian cancer screening, mastectomy, breast reconstruction, and ovarian surgery; and provides information on cutting edge research and potential future advances that may well change the decision-making landscape for women and men facing these hereditary cancers.

All of the latest medical options are discussed, including genetic testing for breast cancer risk, breast cancer and ovarian cancer surveillance, assessing risk, mastectomy and breast reconstruction techniques, surgery, managing menopause, and cancer risks in men who carry mutations on BRCA genes.

POSITIVE RESULTS is "a frank, personal, informative and extremely accessible account of the latest insights into breast cancer genetics, diagnosis and treatment," says Kevin Davies, author of Breakthrough: The Race to Find the Breast Cancer Gene and Cracking the Genome. Explaining in a clear and steady manner the myths and realities of "the breast cancer genes," it lays out all the options in easy-to-follow, compassionate language. It will help women and men decide if they want to pursue genetic testing, guide them in interpreting their test results, and give them a sound basis for making the life-saving decisions required to manage their risks.

Actress, director, and speaker Kate Jackson calls POSITIVE RESULTS a "courageous, generous, open, honest, compassionate, and daring book. [It] is inspiring, empowering, enlightening, amazing, and, for some women, will be a lifesaving encounter with this author, who can guide them to the place where she standsnext to the light at the end of the tunnel."

About the Authors:

Joi L. Morris (Santa Monica, CA) practiced law in Los Angeles for thirteen years. She is now outreach coordinator for FORCE (Facing Our Risk of Cancer Empowered). She speaks often at cancer centers and community events to educate and inform women about the risks of hereditary breast and ovarian cancer.

Ora Karp Gordon, MD, MS (Tarzana, CA) is director of the GenRISK Adult Genetics Program at Cedars-Sinai Medical Center in Los Angeles, the largest clinical adult genetics program on the West Coast. She is also co-director of the Cedars-Sinai Gilda Radner Ovarian and Breast Cancer Screening Program for high-risk women and associate professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.

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Breast Cancer

Monday, February 22, 2010