Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

New results from a phase II clinical trial of the prostate cancer drug abiraterone suggest that it may help men with advanced disease who have tried standard treatments.

However, a Cancer Research UK clinician cautioned that there were still questions to be answered from ongoing studies about how best to use the drug.

Abiraterone was discovered in the Cancer Research UK Centre for Cancer Therapeutics at The Institute of Cancer Research (ICR) and is taken once a day as four pills.

The latest trial, which was led by the ICR and the Royal Marsden NHS Foundation Trust, is the first to investigate the drug in men with such advanced prostate cancer.

A total of 47 men were recruited for the trial, all of whom had late-stage castration-resistant prostate cancer, which means that their disease was advanced and their tumours were no longer responsive to androgen deprivation therapy. In almost all cases, the men's cancer had spread to their bones.

All of the participants had already received hormone therapy and the chemotherapy drug docetaxel, but were no longer responding to those treatments.

By the end of the study period, researchers found that around three-quarters of men had experienced a drop in levels of prostate specific antigen (PSA), which is often raised in men with prostate cancer and can be used to measure disease activity.

In around half of the men, PSA levels fell by at least 50 per cent, while three-quarters of participants also had a drop in the number of tumour cells circulating in their blood.

Three years after the start of the trial, five of the patients were still taking abiraterone and benefitting from the treatment.

New phase II data on abiraterone was reported this week in the Journal of Clinical Oncology from the researchers at the Royal Marsden.

Standard chemotherapy with docetaxel (Taxotere) improves survival by 2 to 3 months, so if the 6 months seen with abiraterone is repeated in a phase III trial, Johnson and Johnson (J&J) and Cougar could well have an approvable drug on their hands.  The other benefit is that the side effect profile is much milder than chemotherapy, which can cause severe myelosuppression in the majority of patients receiving it.

It should be noted that these are advanced patients who have received already several hormonal therapies. The data from this trial will likely provide impetus for larger scale phase III trials, which could be used to seek regulatory approval from the US and EU authorities.

It is, however, obvious that the investigators are unsure yet what role and where abiraterone will eventually be used in the treatment paradigm, but traditional research approaches require that trials investigate advanced disease and then more up the continuum as more data and experience with the treatment is gained.

Of course, there is no guarantee that phase III trials will mirror promising phase II results, especially in the cancer arena, but now, it's nice to report on positive data after a bad run of disappointing trials in oncology of late.

Source: JCO (Abstract)

Posted via web from sally church's posterous

Reid, A., Attard, G., Danila, D., Oommen, N., Olmos, D., Fong, P., Molife, L., Hunt, J., Messiou, C., Parker, C., Dearnaley, D., Swennenhuis, J., Terstappen, L., Lee, G., Kheoh, T., Molina, A., Ryan, C., Small, E., Scher, H., & de Bono, J. (2010). Significant and Sustained Antitumor Activity in Post-Docetaxel, Castration-Resistant Prostate Cancer With the CYP17 Inhibitor Abiraterone Acetate Journal of Clinical Oncology DOI: 10.1200/JCO.2009.24.6819

13 Responses to “J&J's abiraterone shows promise for advanced prostate cancer patients”

  1. dora d.

    we live in Greece.My father has a very agressive prostate cancer.Is it possible for my father or my fathers doctor to find abiraterone?Probably is our only hope.. Thank you


    My name is Andy from Indonesia. My father (64) has a prostate cancer with bone metastasis for the past 4 years. Previously he had hormone-treatment from the doctors, and now continued with an advanced chemotherapy treatment (chemo stage 3). We look forward to have some information about this new medicine, and should this medicine/treatment available in the market, it would give us new hope for the cure. Pleas do not hesitate to email me for the information.

  3. Esha

    My Father (54) is suffering from aggressive prostate cancer. Even chemo like docetexal has failed. Abiraterone seems to be the only hope and it is not possible to wait for the medicine to hit the market. I am from India . Is there any way I can get the medicine? Is is neccesary to be physically present at a hospital for a certain time to be a part of clinical trials. Please help .

  4. MaverickNY

    Hello Esha,
    I am very sorry to hear about your Father. Here is a list of currently open trials that are recruiting people to abiraterone trials:
    You can check out the locations in each study and see if any are open in India. If that does not work, you could contact the sponsor Cougar Biotechnology and see if they have any compassionate use supplies available. You can find their contact details here:
    Hope this helps!

  5. Mehmet

    My name is Mehmet,
    My father is suffering from stage 4 prostate cancer with bone metastasis.Hormone theraphy and docetexal does not respond.We would like to try abiraterone treatment.
    We are from Turkey, can you suggest us any possible contacts?
    Yours Sincerely,

    • Fairy-way

      hey mehmet i am having the same problem here and was wondering did you reach the company there at your home so i can have means to order the medicine for my dad, thanks and waiting for your replay

    • Peter Auigustinus

      Dear Mehmet,
      I am Peter from South Africa, I am in the same boat as your father, I have just received Abiraterone from the UK, you must get hold of Janssen Cilag in the UK, if you respond to me by email I will give you adress, I got the drug airfreighted to me, all others who need this information can write an email to me, and maybe the adresses I have will help you, you are actually in the right time now as it was only launched last week in UK, before that USA and Canada, Good luck to you all, I think there is much more hope now then ever before, and also new drugs in pipeline also go to

  6. Kylie

    My dad is 67 and has prostate cancer with bone metastasis.. Hormone therapy worked for approx 6mths.  We just tried three rounds of chemotherapy (docetexal) and his psa levels went threw the roof!!! He is just been told he will start abiraterone next week.  No one has posted anything past 25 May2010..  If you have tried this treatment can you please post an update!!!

  7. Fairy-way

    I was wondering how to get this medicine cause i need ergently and need some info about the suppliers prices and the delivery means, please replay fast

  8. Peter

    To all prostate cancer patients have hope, believe me the new drug “Zytiga” has been launched, I feel I must try and assist you all try and get it even if all I have is a n adress for you, I have just received my Zytiga  Abiraterone after waiting for 3 years to be launched praise the Lord I have finally received it and when I read your messages of hope and help I jast feel the least I can do is give you an adress to help you further in obtaining this new succesful drug, I know exactly the frustation I went through in eventually getting the drug, as other treatments were all starting to fail,

    Good luck   Peter Augustinus

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