Prostvac Receives Fast Track Status From the FDA – Prostate Cancer Vaccine
Posted Apr 29 2010 7:55am
The news this week on prostate cancer drugs is heating up a bit. Prostvac from Bavarian Nordic is a vaccine that is given to extend the life of prostate cancer patients and the estimated life extension time is stated to be 8 months. Also this week is the expected approval of Provenge from the FDA relative to life extending prostate cancer drugs. Both drugs are doing the same thing, extending life but the processes used for development and delivery are quite different.
Prostvac is what is defined as “off the shelf”, in other words it is a series of injections that doesn’t require the use of the patient’s cells to administer. Both drugs as stated are “safe” and have little or few side effects for the patient and both are well suited for individuals due to age that could not or would not be recommended for chemotherapy or some types of radiation treatments as the cures could be to the point to where the patient could in fact be at a substantial risk, just due to the nature of how chemotherapy works.
I am hoping to see expanded development of similar drugs for other types of cancer. The company also has some other products in the pipeline as well to include HIV and measles. In the past we have seen a lot of publicity with demonstrations from support groups for these types of drug therapies and hopefully progress is moving along fast enough to put some the drugs into their hands where needed. BD
From the website:
Clinical development and data
PROSTVAC™ and related PSA-containing poxviral vaccines have been investigated in more than 500 patients. In the cancer vaccine field, Phase II studies have typically been much smaller.
PROSTVAC™ provides significantly improved survival of 8.5 months on average. By contrast, the only approved treatment currently available in advanced prostate cancer is a form of non-specific chemotherapy, which extends survival by an average of only 2-3 months.
PROSTVAC™ has a very good safety and tolerability profile.
PROSTVAC™ is an off-the-shelf vial vaccine that does not require complex individualized therapy.
PROSTVAC™ is a recombinant viral vaccine that can be manufactured and reproduced easily. Other prostate cancer vaccine candidates are cell-based and therefore difficult to scale, produce and standardize
Bavarian Nordic A/S (Copenhagen:BAVA) announced today that PROSTVAC™ has been granted Fast Track designation by the U.S. Food & Drug Administration (FDA) for its proposed use in the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). The FDA determined that PROSTVAC™ meets the criteria for Fast Track designation as it has demonstrated a potential survival benefit and an excellent safety profile in the intended patient population of men with asymptomatic or minimally symptomatic mCRPC. With an estimated more than 780,000 new cases every year worldwide, prostate cancer is more common than any other cancer in men, and more than 250,000 people die each year from the condition. The potential of PROSTVAC™ to provide a survival benefit with minimal toxicity was based on results from the double-blind, randomized, placebo controlled Phase II trial in which 122 men with mCRPC were enrolled and evaluated.