NPS Pharmaceuticals Inc. announces FDA Extends Review Date For it’s HRT drug

NPS Pharmaceuticals Inc announced the U.S. Food and Drug Administration had extended the review date for its hormone replacement therapy by three months to provide time for a full review of a “major amendment.”

The FDA also asked the company to submit a Risk Evaluation and Mitigation Strategy (REMS) for the drug, Natpara.

The regulator requires a REMS to ensure that the benefits of a drug outweigh its risks.

NPS’s shares fell 4.4 percent to $27.80 in extended trading on Thursday.

The FDA extension follows an 8-5 vote in favor of the drug’s approval by an FDA advisory panel in September.

The drug is designed to treat low levels of the parathyroid hormone (PTH), which causes hypoparathyroidism.

Source: Oct 23 (Reuters) – for complete story visit



Study Suggests Hormone Therapy – Dementia Link

According to research at Stanford and UCLA, there appears to be a link between hormone therapy and dementia. A specific type of hormone therapy may protect areas of the brain responsible for memories in women at risk of developing dementia.

The study included 45 postmenopausal women who had all been using hormone therapy for roughly 10 years. Some of the women were taking estradiol, which is a dominant sex hormone in women and other women in the study had been taking Premarin, which contains a mix of estradiol and many other substances. The women were then divided into two groups randomly, one group stopped hormone therapy for 2 years, and the other group continued for two years.

After the two years,  the researchers did brain scans looking at metabolic activity on all the women and compared these scans to the scans performed at the beginning of the study. Looking at metabolic activity would show whether or not there was any deterioration of brains in women during that period of time.

The women who continued hormone therapy using estradiol seemed to be protected, while the others who stopped all treatment, or were taking the other hormones, showed declines. For more information click here

New Study Credits Exercise with Reducing Stroke Risk from Hormone Replacement Therapy

Exercise may reduce some of the increased risk of hormone therapy, according to researchers.

Data analysis from the California Teachers Study indicates women being treated with hormones had a 42% increased risk of stroke, however that number dropped to a 30% greater risk if they exercised at least 3.5 hours per week, according to Sophia Wang, PhD, of the Beckman Research Institute at the City of Hope in Duarte, Calif., and colleagues.

According to their findings at the American Stroke Association’s International Stroke Conference in San Diego.

Wang and colleagues looked at data on 133,479 women enrolled in the California Teachers Study between 1995 and 2010.

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Clinical trial tests targeting prostate cancer treatment

Study to evaluate whether drug works better against tumors with specific genetic anomaly

ANN ARBOR, Mich. Are certain drugs more effective against some types of prostate cancers than others? Researchers know that not all therapies work for all patients – the next question is to figure out how to match the right treatments with the right patients.

Hormone Therapy

A new clinical trial is testing whether targeting treatments to a genetic anomaly can lead to better treatments for prostate cancer. The trial, led by investigators at the University of Michigan Comprehensive Cancer Center, is being conducted at 11 sites throughout the country.

The phase 2 trial will look at patients with castration-resistant metastatic prostate cancer, which means the cancer has spread and has stopped responding to hormone-based treatments. The target being evaluated is a genomic rearrangement that causes two genes called TMPRSS2 and ERG to fuse together. This gene fusion, believed to be the triggering event of prostate cancer, was initially discovered in 2005 by U-M researchers led by Arul Chinnaiyan, M.D., Ph.D.

“We hope this study will help us understand why certain patients respond to therapy and certain patients do not. By better understanding the evolving biology of prostate cancer, we will have the ability to better treat the disease,” says the clinical trial’s principal investigator, Maha Hussain, M.D.,FACP, professor of internal medicine and urology, and associate director of clinical research at the U-M Comprehensive Cancer Center.

Study participants will undergo a biopsy to determine whether their tumor expresses the gene fusion, which occurs in about half of all prostate cancers. All participants will receive the standard hormone-based therapy abiraterone. Each group – gene fusion positive and gene fusion negative – will then be randomly assigned so half of participants will also take an experimental drug called ABT-888 in addition to abiraterone.

The trial’s design is based on scientific data indicating the potential for improving abiraterone’s effect on the tumor and that this improvement may be more evident in patients whose tumors have the gene fusion.

“Can we better select treatments for prostate cancer based on the genes in the patient’s cancer? We hope that what we learn from this study will help us to better control and better treat the deadly stage of prostate cancer,” Hussain says.

ABT-888 is a new type of cancer-fighting drug that’s designed to block an enzyme called PARP that’s known to directly interact with the gene fusion, leading to cancer growth and progression. Lab studies have found that a PARP inhibitor, when added to hormone therapy, helped shrink tumors in general and especially those expressing the TMPRSS2:ERG gene fusion. This new clinical trial tests that finding in patients.

“In order to beat your enemy you’ve got to understand it. We are getting closer and closer to understanding the enemy which is cancer,” Hussain adds.

For information about this trial, “A Randomized Gene Fusion-Stratified Phase 2 Trial of Abiraterone with or without ABT-888 for Patients with Metastatic Castration-Resistant Prostate Cancer,” call the U-M Cancer Answerline at 800-865-1125.

Prostate cancer statistics: 241,740 Americans will be diagnosed with prostate cancer this year and 28,170 will die from the disease, according to the American Cancer Society

Funding: National Cancer Institute grant N01-CM-2011-00071C, U.S. Department of Defense grant PC080189, Prostate Cancer Foundation

Disclosure: The University of Michigan has received a patent on the detection of gene fusions in prostate cancer (US 7,718,369), on which faculty members Scott Tomlins, M.D., Ph.D., and Arul Chinnaiyan, M.D., Ph.D., are co-inventors. The diagnostic field of use has been licensed to Gen-Probe Inc. Chinnaiyan also has a sponsored research agreement with Gen-Probe. Gen-Probe has no role in the design or experimentation of this study.

University of Michigan IRBMED#: HUM00060473

If You are Feeling Tired All The Time, It Could Mean You Need Hormone Therapy

Aging is an interesting thing. Your body changes so much over your lifespan. Your younger years are usually your healthiest, when you feel the most energenic, strong and carefree. As you age, you lose some these feeling. In some, the loss of energy can occur earlier than in others. What causes this? Well for 30 year old men and women, feeling tired all the time can be a indicator of hormone imbalance or difficiency. You may have seen the TV commercials “Is it low-T”? Well if you’re a 30+ year old, and you’re feeling less energy than you used to, or just tired more than usual, this commercial was directed toward you. You could have low testosterone, which is what “Low-T” means. If you’re feeling less energy, more tired than usual and it’s over a period of time, you should see a doctor. There’s a great doctor’s office that provides hormone therapy in Miami, they have an awesome spa there, too. They can test you for hormonal imbalance and if it’s determine that you can benefit from hormone replacement therapy, they can discuss your options and help you decide if it’s a good fit for you. Hormone replacement therapy isn’t going to be the answer for everyone, but for those who are suffering from hormone imbalance, HRT is a life-changer. Feeling young again is worth it, too.