Peter, you asked
>>I know of no example where they let anyone do a trial with a combination of two unapproved drugs. (Anyone else know of an example of this?)>>
That seems to be very difficult. This morning however, Medarex said the following.
PRINCETON, N.J., Jan. 9 /PRNewswire/ -- Medarex, Inc. (Nasdaq: MEDX - news) today announced its multi-pronged tumor vaccine clinical program for the treatment of a variety of tumors, including advanced or incurable malignant melanoma. Phase I/II clinical trials of two of these potential melanoma products are underway. This clinical program employs a series of different melanoma vaccines used in conjunction with MDX-010, Medarex's fully human antibody that binds to CTLA-4, a molecule associated with the suppression of normal immune responses to cancer.
The vaccines, which contain immune targets expressed by certain tumor cells, are designed to trigger a response from the patient's own immune system against his or her cancer. Currently, Medarex is pursuing clinical testing of MDX-010 in conjunction with two different melanoma vaccines, with additional vaccines expected to enter clinical trials during 2002.
I am not aware of any approved cancer vaccines for either malignant melanoma or any other cancer indication. So, it seems that Medarex are in effect doing exactly what you were asking about. I might be wrong though. That happens all the time.
Ice |