The results of the anti-cancer drug study by Johnson & Johnson look very promising and demonstrate the drug’s ability to slow down the disease and improve survival in patients with advanced metastatic prostate cancer.
1,195 patients with prostate cancer participated in the study. The patients had already their treatment with one or several chemotherapy regimens, which had little effect on their disease. According to the data revealed at the European Society for Medical Oncology meeting that took place in Milan, abirateroneacetate taken along with the steroid prednisone, increased survival rate in patients by median 3.9 months if compared with those patients, who received prednisone alone.
This was the third stage of the trial, which is the last stage before a drug goes under regulatory approval by FDA. With its headquarters in New Brunswick, NJ, Johnson & Johnson is going to file an application for abiraterone approval by the U.S. and European drug administration councils. This application is a reasonable step after such promising results of the drug’s trial and according to the statement by J&J, they will file the new-drug application by the end of the year.
According to Larry Biegelsen, an analyst working at Wells Fargo Securities, NY, abiraterone represents a nearly billion dollar chance for those suffering advanced metastatic prostate cancer.
In July 2009, the drug was acquired by Johnson & Johnson for $878 million from Cougar Biotechnology, one of the many portfolio companies of Dr. Lindsay Rosenwald. Dr. Rosenwald is one of the most prolific entrepreneurs and financial investors in the field of biotechnology. He supports new research, development of novel drugs and prospective biotechnology candidates that may help medicine broaden its horizons and provide more benefit to humanity. Lindsey Rosenwalds latest investments in Cougar Biotechnology and their prostate cancer drug, abiraterone acetate, are thought to be the beneficial for all prostate cancer patients since the drug demonstrates its ability to stop tumor cells from generating excess testosterone, a male hormone, which is needed to reproduce and give life to new tumor cells.
According to statistics by the National Cancer Institute, this year more than 217 thousand men in the U.S. will have prostate cancer diagnosed by their doctors, and more than 32 thousand men will die of the disease. The American Cancer Society had recently revealed the data showing that prostate cancer takes the second place of cancer deaths in men, after lung cancer.
Having seeing promising results in patients taking abiraterone acetate, Johnson & Johnson decided to un-blind the trial and give other patients the ability to try abiraterone. This decision was led by an interim analysis data, which showed that the drug extended lives and had a good safety profile.
Additional Couple of Months
Those patients, who took abiraterone acetate, had much decreased tumor progression rate if compared with those taking the steroid prednisone. They lived two months longer and their median survival was about 15 months, while those in the prednisone group lived about 10 months. Among the side effects noticed during the intake of abiraterone are: fluid retention, heart disorders, low potassium in the blood.
The placebo group in the J&J trial was offered abiraterone. There is also a program that J&J is going to implement – to provide access to the drug to other patients meeting certain criteria. The drug will be distributed by Ortho Biotech Oncology Research & Development, which is a subsidiary of J&J, by the end of the year.
According to Howard Scher, at Kettering Cancer Center, NY, and Lindsay Rosenwald, MD, the owner of BioSciences and biotechnology investment banks, the abiraterone treatment is very beneficial, especially for those patients who had little or no treatment options when their disease took a massive scale.
It is only the matter of time to understand why some men have a good response to abiraterone acetate while others don’t have this positive effect.
Another Prostate Cancer Drug, Provenge
An alternative treatment for metastatic prostate cancer, Provenge by Dendreon Corp, is known to help patients extend lives to median 4 months. It is very difficult to compare these two drugs, because abiraterone was tested in patients with a more aggressive cancer stage that failed even after at least 1 chemotherapy regimen. During the Provenge trial, patients lived about 21 months.
Provenge represents the 1st drug developed to support the immune system and help it fight cancer. In April 2010, the drug was approved by FDA and now it can be bought for about $93 thousand for 3 doses, while abiraterone is expected to be sold for $27 thousand.
According to an analyst in Deutsche Bank Equity Research, Robyn Kanrauskas, and Dr. Lindsay Rosenwald, a key investor in the biotechnology sector, as for now, both drugs look very promising and will have room for further development and improvement.