Posted: 23 Feb 2010 11:04 AM PST

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HealthDay News

In some states, access to mammograms for women ages 40 to 49 has decreased since new breast cancer screening guidelines were released in November by the U.S. Preventive Services Task Force, according to a new survey.

The task force recommended that women at average risk for breast cancer should start having mammograms every two years at age 50 instead of annual screenings starting at age 40.

The online survey of more than 150 breast cancer health educators and providers in 48 states and the District of Columbia, conducted by the Avon Foundation for Women, found that respondents from a fourth of the areas surveyed reported changes in their states' early detection programs for breast and cervical cancer.

The respondents said that the task force guidelines and other factors, including budget cuts, have resulted in fewer women having mammograms or the elimination of early breast cancer screening programs for women younger than 50 offered through state-administered breast cancer screening programs.

California, Florida, Illinois, Michigan and New York are among the states that have made changes in their state's breast cancer screening programs since the release of the guidelines.

The survey, conducted in early February, found that 24 percent of respondents said there's been a decrease in the number of women younger than 50 being screened or seeking appointments for mammograms at their facilities. Many women who were already reluctant to have a mammogram are using the new guidelines to put off breast cancer screening, according to some of the respondents.

"We are concerned that some women may simply accept the new recommended guidelines as standard -- not taking into consideration their own health history and other breast cancer risk factors," Marc Hurlbert, director of the Avon Foundation Breast Cancer Crusade, said in a news release from the foundation.

All participants in the survey were Avon Foundation grant recipients.

More information

The U.S. National Cancer Institute has more about breast cancer screening.

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New ovarian and breast cancer treatments - Daily News and Analysis

Posted: 23 Feb 2010 01:53 AM PST

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WASHINGTON: New medication, consisting of a blend of a protein inhibitor and traditional anticancer drugs, being developed to treat ovarian and breast cancer has been found to be effective, say researchers.

The finding has appeared in a new review for Faculty of 1000 Biology Reports.

Susan Bates and Christina Annunziata analysed numerous recent papers on this form of treatment, which takes advantage of the synthetic lethality of BRCA (breast cancer susceptibility genes) and poly-ADP ribose polymerase (PARP) proteins to attack cancerous cells even as it spares healthy ones.

BRCA and PARP are two major players in DNA repair and have different but complementary functions in the cell. Loss of the BRCA protein allows the cell to survive but greatly enhances its chances of becoming cancerous through the accumulation of mutations. However, the loss of both proteins kills the cell in a process called synthetic lethality.

The use of drugs to block the activity of PARP in cells missing BRCA, such as those found in certain breast and ovarian cancers, can spare healthy, non-cancerous cells because they have functional BRCA and are not affected by the loss of PARP. Thus, only cancer cells without functional BRCA protein are killed by drugs that inhibit PARP.

Recent clinical trials have demonstrated that cancers caused by mutations that knock out BRCA activity can be controlled by blocking PARP activity with specific drugs. Patients were treated with traditional anticancer drugs alone or in combination with one of two new PARP inhibitors, olaparib or BSI-201.

Bates points out that patients on combination therapy had improved "[disease] progression-free survival, and overall survival" as compared to patients treated with traditional drugs alone.

Bates is positive about the promise of combining PARP inhibitors with existing cancer drugs. She says that the results of these clinical trials "have provided proof of principle in achieving synthetic lethality" with PARP-inhibiting drugs and that treatments combining novel PARP inhibitors with traditional chemotherapeutic drugs have the potential to vanquish BRCA-associated breast and ovarian cancers.

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Hot Off the Wire - dBusinessNews.com

Posted: 22 Feb 2010 04:10 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

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 Elestrinâ„¢ (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-Gelâ„¢, 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 (BioLookâ„¢), 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. 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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Breast Cancer

Tuesday, February 23, 2010

plus 2, Access to Mammograms Drops After Guidelines Change - Palm Beach Interactive

plus 2, Access to Mammograms Drops After Guidelines Change - Palm Beach Interactive

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