A quick update on Apoptone in hormone-refractory prostate cancer

Back in 2008 we first mentioned the initiation of clinical trials of a drug called Apoptone or HE3235 in men with hormone-refractory prostate cancer. Data on the development of Apoptone was another item on the agenda at the annual meeting of the American Society of Clinical Oncology (ASCO) earlier this week. The abstract of the paper by Montgomery et al., as well as a detailed media release from Harbor Biosciences, are both available on line.

HE3235 is another new type of hormonal agent that is know to suppress the growth of androgen-dependent prostate cancer cells. It is currently in early (Phase I/II) trials to assess its safety, and to identify the most appropriate dose of the drug for future clinical trials.

The data presented at the ASCO meeting appear to show that the drug is active in men with hormone-refractory prostate cancer at doses as low as 10 mg/day and as high as 350 mg/day. Indeed there are plans now to test doses of HE3235 as high as 700 mg/day. In men with hormone-refractory (castration-resistant) prostate cancer who had not received chemotherapy, a daily dose of 100 mg showed a median time to disease progression of >16 weeks and 80 percent of the patients remained on treatment at that time.

HE3235 is being tested in chemotherapy-naïve and in post-chemotherapy patients, and responses to therapy have also been noted in very heavily pre-treated patients who have progressed after treatment with ketoconazole, docetaxel, abiraterone acetate, and MDV 3100.

A large Phase IIb clinical trial of HE3235 — currently projected to enroll about 225 patients with chemotherapy-naïve and post-chemotherapy castration-resistant prostate cancer — will be an important step in the next stages of development of this agent. Initiation of this trial will not be started until the most appropriate dose of HE3235 has been determined, however.

Significant treatment-related adverse events in the ongoing Phase I/II appear to be relatively uncommon and manageable. If this was not the case, it would be most unlikley that the developers would still be testing highber doses of the drug. However, caution is always wise in assessing safety data from early clinical trials.

While HE3235 has a long way to go in its development, it is yet another example of the wide range of drug types now being explored in the treatment of late stage disease.

For readers who notice that HE3235 was originally being developed by a company called Hollis-Eden Pharmacauticals and is now being developed by Harbor Biosciences, the explanation is simple. The company changed its name earlier this year.

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