3 (1 votes)

Healthcare Prof:

5 (2 votes)

Dendreon Corporation (Nasdaq: DNDN) announced that the pivotal Phase 3 IMPACT study of PROVENGE(R) (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted within the study successfully achieving the pre-specified level of statistical significance defined by the study’s design. The safety profile of PROVENGE appeared to be consistent with prior trials.

The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Remedy) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).

PROVENGE is Dendreon’s investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically developed to engage the patient’s own immune method against cancer.

Detailed results from the IMPACT study will be presented during a plenary session in the American Urological Association’s Annual Meeting in Chicago on Tues., Apr. 28 at 2:20 pm CT.

“Survival may be the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint with the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE could prolong survival,” mentioned Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. “We are immensely grateful to our clinical investigators and the much more than 1,000 men with advanced prostate cancer who have participated in our studies over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies.”

“The successful outcome from the Phase 3 IMPACT study provides validation with the long-pursued goal of harnessing the human immune technique against a patient’s own cancer,” continued Dr. Gold.

Because the data meet the criteria and specifications outlined in its Special Protocol Assessment (SPA) agreement with the FDA, Dendreon intends to file an amendment to its existing Biologic License Application (BLA) inside the fourth quarter of this year to gain licensure of PROVENGE.

Prostate cancer will be the most common non-skin cancer in the United States and the third most common cancer worldwide. A lot more than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.

About PROVENGE

PROVENGE (R) (sipuleucel-T), an investigational product in development for men with androgen-independent prostate cancer, may represent the first product in a new class of active cellular immunotherapies (ACIs). PROVENGE and other ACIs are uniquely created to make use of live human cells to engage the patient’s own immune method with the goal of eliciting a specific long-lasting response against cancer. In controlled clinical trials, the most common adverse events were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade with a short duration of 1-2 days following infusion.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission would be to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates created to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of information to the FDA and approval of product applications by the FDA and risks and uncertainties inherent inside the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that could cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret information differently than we do or require much more information or a more rigorous analysis of information than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product could not be indicative of results obtained in a later clinical trial, risks that we could lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property.

Source: Dendreon Corporation

View drug information on Provenge.

5 (1 votes)

Healthcare Prof:

Article Opinions:1 posts
The New York Times on Saturday examined how the current economic recession is contributing to a recent rise in vasectomies. According to the Times, it is “too early to proclaim a bona fide trend in elective sterilization, because no organization regularly tracks the number of vasectomies performed on an annual or even a monthly basis.” Based on a 2006 study published in the Journal of Urology, about 527,000 vasectomies are performed annually inside the U.S.

However, the “recent anecdotal data, if they hold, would have a historical parallel inside the Great Depression, when the birth rate fell sharply,” the Times reports. Excluding college costs, a child born in 2006 will cost middle-income parents $260,000 by the time the child reaches age 17, based on USDA.

The Times highlighted three clinics and physicians’ offices that have noticed a recent increase in vasectomies. At one Planned Parenthood affiliate serving California’s San Diego and Riverside Counties, requests for vasectomies increased by 30% to 64 procedures inside the first three months of 2009. Spokesperson Vince Hall stated, “The recession has created a new level of urgency among our clients,” adding, “We used to have a three- to six-week waiting period. Now men have to wait two-and-a-half months to obtain an appointment.” Hall added that a possible contributing factor to the increase is that unemployed men often qualify for no-cost vasectomies under California’s Family Planning, Access, Care and Treatment Program.

Marc Goldstein, director of reproductive medicine and microsurgery in the New York-Presbyterian Hospital/Weill Cornell Medical Center, stated that over the past five months, he has performed a lot more vasectomies than usual. From January 2008 by means of October 2008, he was performing about six vasectomies monthly; nonetheless, since November 2008, he has been performing an average of nine procedures monthly. Goldstein stated, “I’ve been in practice for 30 years, and I’ve never seen a spike like this,” adding, “Many of my clients work in finance and say they feel anxious about the expense of an added child.”

Charles Wilson with the Vasectomy Clinic in Seattle mentioned that he has performed 123 vasectomies monthly on average, a 13% increase over his 2008 average. He said, “Some come in because they are out of work and have far more time on their hands to take care of medical issues,” adding, “Others are afraid of losing their job and want to obtain their vasectomy done before they lose their wellness insurance.” In addition, Web traffic to Vasectomy.com increased by 17.5% inside the first three months of 2009, compared with the first quarter of 2008. Vasectomies — which cut or seal the vas deferens, the tubes that carry sperm from the testicles — usually cost between $500 to $1,000 and normally are covered by insurance (Alderman [1], New York Times, 4/11).

The Times on Saturday also examined birth control options for women, including tubal ligation, which is much more popular than vasectomy, even though it’s much more complicated and costly. Another option is Mirena, an intrauterine device that delivers a steady dose of the contraceptive levonorgestrel for up to five years; and oral contraceptives, which can cost as little as $9 per month for generic brands (Alderman [2], New York Times, 4/11).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Wellness Policy Report is a free service with the National Partnership for Women & Families, published by The Advisory Board Company.

? 2009 The Advisory Board Company. All rights reserved.

View drug information on Mirena.

5 (2 votes)

Healthcare Prof:

The European Association of Urology (EAU) has taken into consideration the recent scientific information on randomised screening studies on prostate cancer (Schroder et al, NEJM 2009). Based on the results with the European Randomised Study for Screening of Prostate Cancer (ERSPC), the EAU has formulated a position statement regarding prostate cancer screening in Europe, and the subsequent actions to be taken by health pros and wellness authorities.

In summary, the ERSPC reports on a relative prostate cancer mortality reduction of at least 20% by PSA-based population screening in 162,000 asymptomatic men aged 55-69 years. For every prostate cancer death prevented, 1,410 men have to undergo screening, while 48 are needed to be treated in excess with the control group population to save one prostate cancer death. Results with the PLCO (Prostate, Lung, Colon and Ovary) US randomised study of screening had been also published within the same issue with the NEJM (Andriole et al, NEJM 2009) and to date show no significant effect of screening on mortality from the disease, but suffered from a significant level of contamination inside the control arm. The study continues.

The EAU adopts the conclusions of the ERSPC study and recognizes the benefit of screening in terms of mortality reduction, as well as the adverse effects of overdiagnosis and overtreatment of prostate cancers which could be quantified for the first time in the setting of a randomized screening study. Further publication of relevant data is awaited from the ERSPC group in due course to inform the debate.

In the interest of men’s health in Europe and elsewhere, the EAU formulates the following statements:

— Prostate cancer is a key well being dilemma, and one with the main causes of male cancer deaths. Nonetheless, current published information are insufficient to recommend the adoption of population screening for prostate cancer as a public wellness policy due to the large overtreatment effect. Before screening is considered by national health authorities, the level of current opportunistic screening, overdiagnosis, overtreatment, quality of life, costs, and cost-effectiveness should be taken into account.

— Overdiagnosis of prostate cancer leads potentially to significant overtreatment. Health pros, especially urologists, should avoid overtreatment by developing safe methods of cancer surveillance/monitoring without invasive therapy. Invasive therapies should be tailored to patients’ needs and the prognosis of cancers diagnosed.

— Current screening algorithms are insufficient due to a lack of specificity and lack of selectivity for aggressive cancers which require therapy. The development of novel diagnostic and prognostic markers and imaging modalities is needed urgently to enhance the predictive value of screening tools.

— Inside the absence of population screening, the EAU advises men who consider screening by PSA testing and prostate biopsy to obtain information on the risks and benefits of screening and individual risk assessment.

— The EAU and the ERSPC study group represent essential European stakeholders to further develop well being strategies for prostate cancer screening.

— The EAU promotes the top quality of care for prostate cancer patients in Europe in collaboration with the patient support organization Europa Uomo by means of the development of information support and guidelines.

— The EAU wishes to support and foster study needed to develop reliable active surveillance protocols for low-risk prostate cancers, prognostic markers, and targeted therapies in order to deliver optimal patient care.

Source: European Association of Urology

5 (1 votes)

Healthcare Prof:

A Queen’s University study team has found that a painful pelvic affliction associated with adult men occurs as frequently in adolescent boys. Chronic prostatitis or chronic pelvic pain syndrome (CP/CPPS) is a urogenital disease associated with persistent and life-altering pelvic and genital pain.

This could be the first study to estimate the prevalence of CP-like symptoms in adolescent males, and to show the negative impact that pain, urinary symptoms, and depression have on boys’ top quality of life.

“Boys are suffering in a medical silence, where physicians and even specialists remain unaware of the occurrence and strong negative developmental impact of these disease symptoms,” says lead researcher Dean Tripp, professor of Psychology and Urology at Queen’s. “These terrible symptoms of pain are interfering with the developmental trajectory of adolescent boys. Social relationships and academic performance are two of my key concerns,” he adds.

“It is prevalent, debilitating, and it costs society a lot in direct and indirect ways,” says Urology professor Curtis Nickel, who co-authored the study. “CP/CPPS is the black sheep of the urologic diseases,” he says. “It used to be prostate cancer, and before that it was ED. We have always been aware that adult men are suffering and are reluctant to seek medical help. Now we know adolescents are, too.”

The researchers hope that a better understanding with the prevalence of CP/CPPS will lead to better treatment and diagnosis of the disease. Since therapy is difficult, and most patients can’t be cured if they have CP/CPPS for 10 years or longer, the researchers believe that early diagnosis is the key to management

The study looks not only in the prevalence of CP/CPPS in teenage boys, but also in the psychological impact associated with the symptoms. “In older men, CP-like symptoms are so devastating they are compared to the negative life impact of Crohn’s disease, diabetes or heart attack,” notes Dr. Tripp. “Our initial study indicates that these CP-like symptoms are having a significant negative quality of life impact in young boys. We must not tolerate inaction on this matter,” he adds.

Source:
Stephanie Earp
Queen’s University