Yesterday May 16, 2012, the House Appropriations Committee released their draft committee report to accompany the FY13 Defense Appropriations Act. This draft included the CDMRP requested budget for 2013.
The good news is that the ask includes $80 million dollars for the Prostate Cancer Research Program. Although this is the same amount prostate cancer received for last year (and for many other of the past years) it should be considered a major victory for us given the general economic climate and the propensity of the current congress to cut funds.
The full Appropriations Committee is marking the bill up today, so we are not yet at the finish line for the fiscal year of 2013.
To all of you you have taken an active role in advocating for the continued fundin of this vital program, I gave you a hardy “Well Done.”
Joel T Nowak, M.A., M.S.W.
Today, May 16, 2012, Dendreon, the makers of Provenge, disclosed a new analysis of data of its pivotal 512-patient study of men with castrate resistant prostate cancer who received sipuleucel-T (Provenge). The new analysis separated the men in the study into four quartiles based on their prostate-specific antigen (PSA) scores. The initial design of the study did not incorporate this analysis so its results might not be accurate.
This new look at the data showed that in men with castrate resistant prostate cancer, Provenge worked better (men had a longer survival advantage) if their PSA was lower, reflecting less advanced prostate cancer. This conclusion is in fact consistent with many “best guesses” of many of the knowledgeable scientists.
The analysis was led by Gerald Chodak, M.D. at Weiss Memorial Hospital in Chicago. It was posted online today on the American Society of Clinical Oncology’s in advance of its annual meeting in Chicago.
According to Mark Frohich, Chief Medical Officer at Dendreon, “All of these analyses support the robustness of clinical benefit for patients, and this PSA quartile data is helpful for patients when you think about sequencing of therapy…. “The data strongly argues that using it as early as possible is the best for the patient and still allows you to go on and get other therapies.”
In this new analysis of the Provenge study the researchers looked at survival times of men who entered the trial with PSA scores of less than or equal to 22.1; between 22.1 and 50.1; between 50.1 and 134; and over 134.
The chart below shows the survival time when matched with entering PSA scores. Provenge patients lived longer than placebo patients in all four quartiles, but the difference in median survival times was the largest among those with lower PSA scores.
PSA of 22.1 or less PSA of 22.1-50.1 PSA of 50.1-134 PSA of 134 and up
Provenge 41.3 months 27.1 months 20.4 months 18.4 months
Placebo 28.3 months 20.1 months 15 months 15.5 months
Difference 13 months 7.1 months 5.4 months 2.8 months
–Source, Gerald Chodak et al
The real issue is how valid is this data or is it just a fluke in the design of the trial? My gut and hope is that the data is real and this might provide a kick to the doctors to get teir patients started earlier on Provenge.
Joel T Nowak, M.A., M.S.W.
http://abstract.asco.org/AbstView_114_94325.html
GTx Receives clearance for New Capesaris Trials
By · CommentsGTx Inc. announced that FDA regulators will allow it to restart the clinical trials of its investigational prostate cancer drug Capesaris for men with castrate resistant advanced prostate cancer.
They anticipate that the trials of Capesaris will begin during the third quarter of 2012. The trial is designed to evaluate Capesaris as a secondary treatment for advanced prostate cancer that no longer responds to hormone treatment, a condition known as being castrate resistant.
The trial protocol will test three different doses of Capesaris on 75 men.
In February the he FDA ordered GTx to stop the clinical trials of Capesaris when GTx told the FDA that men who took the drug had an increased risk of developing blood clots. The company then stopped enrolling and treating men, and said it would test lower doses of Capesaris as a second treatment for prostate cancer.
So, look forward to these new trials for men who are castrate resistant.
Joel T Nowak, M.A., M.S.W.
Why Are Gays Excluded From Medical Research Studies?
By · CommentsFor a reason that I can not figure out there are a small but still significant portion of medical studies that automatically exclude gays from participating without an apparent scientific reason. These studies usually have requirements that the subject be in a “reciprocal relationship with a person of the opposite sex.”
Sometimes the exclusion of gays is appropriate, for example if the study were looking at how HIV spreads during male-female sex. In this example the researchers would only want heterosexual subjects. But in most studies that exclude gays from the subject pool there is no legitimate reason for the exclusion.
Brian Egleston, a bio-statistician at Fox Chase, made the observation while overseeing enrollment of patients into clinical trials at the cancer center. “When I first saw this, I thought it was a fluke. The second time, I thought I’d dig deeper,” he said.
Egleston and Roland Dunbrack Jr., a biologist, and Dr. Michael J. Hall, a medical oncologist, did a spot check of a government database of thousands of studies and turned up more examples, most of them private-industry trials. They found cases where the reason for excluding gays is not clear: tests of a drug for attention-deficit disorder, a treatment for erection problems after prostate cancer surgery, and studies on sexual function related to diabetes, depression and benign enlargement of the prostate as men age.
Currently, researchers seeking federal support for their work must explain why a study excludes a group based on gender, race or ethnicity. However, no explanation is needed for exclusion based on sexual orientation.
Joel T Nowak, M.A., M.S.W.
