On Thursday evening I had the opportunity to meet Dr. Oliver Sartor from the University of Tulane. At that time he informed me that Bayer had finally submitted the required paperwork to the FDA for formal approval of radium-233 chloride. For those of you who are not familiar with Dr. Sartor, he is both an extraordinary prostate cancer oncologist prostate cancer researcher.
Dr. Sartor’s most recent research has been as a lead investigator in the development of radium-233 chloride (Alpharedin). Alpharedin, an investigational alpha particle emitting radiopharmaceutical is designed to be a systemic treatment for men with castrate resistant advanced prostate cancer with multiple bone metastases.
The phase 3 trial (ALSYMPCA) was halted early by the data monitoring committee because they found a statistically significant improvement in the survival of men receiving Alpharadin of 14 months compared with 11.2 months in those receiving placebo (P=.0022; hazard ratio, 0.699).
This trial had enrolled 922 men with castration-resistant prostate cancer and symptomatic bone metastases, allocated 2:1 to drug:placebo, both administered intravenously at intervals of 4 weeks, for 6 sessions. Once the Independent Data Monitoring Committee called for the trial to be stopped all patients receiving placebo were offered the active drug.
Until its formal FDA approval Alpharedin is now available through an early Access Clinical Trial which is available currently in seven sites. For a current list of sites look at the post at: http://advancedprostatecancer.net/?p=3580.
Anyway, I wanted to let you know that Dr. Sartor has agreed to give Malecare an opportunity to make a pod cast with him as soon as the FDA approves the treatment (assuming that it will be approved).
Joel T Nowak, M.A., M.S.W.