The results of Phase III clinical trial show that patients suffering from castration-resistant prostate cancer with metastases live much longer when treated with a newly discovered drug abiraterone acetate if compared to placebo.

According to Dr. Johann de Bono, a lead analyst at the Institute of Cancer Research, and Dr. Lindsay Rosenwald, a leading investor in the biotechnology sector, abiraterone is “a major step forward in prostate cancer” treatment. The data of the trial were presented at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy and demonstrated a significant improvement of survival in patients undergoing the abiraterone treatment. They lived nearly four months longer than the patients who received placebo.

In many cases, prostate cancer progresses even after receiving chemotherapy, therefore it is critically important to address the needs of the patients with advanced prostate cancer. As Dr. Rosenwald and Dr. de Bono say, patients with castration-resistant prostate cancer aggravated by metastases have a very poor prognosis and have only 3 to 5 years of life after the diagnosis is set. For such men, abiraterone can prolong life.

Scientific research showed that prostate cancer depends on the level of male hormone testosterone. If this hormone is low in the body, this may reduce the growth of the tumor. However, after a long-term hormonal treatment, many prostate cancers become resistant to hormones and start growing again. This is where abiraterone acetate can help. It is specifically designed to inhibit the production of androgen in the adrenal glands, testes as well as prostate cancer itself. 1,195 patients from 13 countries participated in the Phase III trial. Most such patients were treated with one of the chemotherapeutic drugs composed of docetaxel, an anti-mitotic chemotherapy drug.

398 patients received the corticosteroid prednisone plus placebo, and they lived for about 10 months. 797 patients took abiraterone acetate plus prednisone and their survival was about 15 months.

A pre-specified interim analysis of the study demonstrated the advantages of abiraterone acetate. Because of this, the Independent Data Monitoring Committee recommended J&J’s to unblind the trial and allow the patients in the placebo group to be treated with abiraterone.

Although there are obvious benefits of the drug, there are still some unclear points about abiraterone, e.g. how to determine which patients should be treated with the drug. Obviously, this is a significant step forward, more work is required to improve the results in patients with prostate cancer.

Dr. Lindsay A. Rosenwald and his portfolio companies keep a close eye on the trial results and promote the drug by making investments in its trial and further commercialization.

Prof. Carsten Bokemeyer, director of University Cancer Center Hamburg, Germany, believes that abiraterone acetate can be a great addition to the treatment of prostate cancer.

Since patients with advanced prostate cancer have very limited treatment options, abiraterone is a good choice with low toxicity that significantly extends life. Furthermore, the results of the trial also show that patients after chemotherapy can be treated, which is very important for “the future management of castration-resistant prostate cancer.”

The acquisition of Cougar Biotechnology Inc. by Johnson & Johnson seems to be a great success leading to promising outcomes in the treatment of prostate cancer in men. Late in 2010, J&J halted its Phase III clinical trial of its novel drug candidate, abiraterone acetate, which was originally studied by the analysts and scientists at Cougar Biotechnology. It is well known that Dr. Lindsay Rosenwald, along with his team of specialists in the biotechnology sector, invested in the first trial stages of abiraterone. The first clinical trial of abiraterone showed great success and promising results; therefore Lindsay Rosenwald funded Cougar Biotechnology and promoted indirectly the development of this drug and its further acquisition by Johnson & Johnson. Because interim analysis of the Phase III demonstrated good results, it was suggested that the company revealed the data and allowed the patients treated with placebo to take abiraterone. In October, the company is going to reveal the exact numbers and the time abiraterone can prolong lives. This data will be shared at a scientific meeting, which will take place in Milan. If the drug has statistically larger survival in prostate cancer patients, this will be enough for abiraterone to get approval, given the poor prognosis for those men, who failed Taxotere treatment offered by Sanofi-Aventis.

Sanofi is going to file marketing applications for it’s another drug, Cabazitaxel. However, it is still difficult to compare the drug with abiraterone. Patients treated with Cabazitaxel lived median 15.1 months. That time the drug was compared to Novantrone, a product by OSI Pharmaceuticals and EMD Serono. J&J compared its abiraterone plus the steroid prednisone treatment to prednisone alone.

It doesn’t matter what drug hits the leading position, since it is the fact that the sales of Provenge(a drug by Dendreon) won’t be affected. The drug was developed as an aid to the immune system and is commonly used in patients with castrate-resistant prostate cancer, whose disease progressed in spite of their hormonal therapy. Both these drugs are going to be used when patients fail their Taxotere treatment. Provenge is most likely to be used in these cases, too.

Since prostate cancer is considered to be the disease, which is very difficult to treat, abiraterone may be a good option for patients. Investors, like Lindsay Rosenwald, MD, have already noticed prospects of this drug and invested in its research and development giving more survival chances to men with prostate cancer.