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Alert Number 75

Genitope: Vaccine Approach to B-Cell Cancers

Date: February 4, 2005

Just about a year ago I reported on Genitope and their idiotype vaccine approach to B-cell cancers. You can read the article by clicking on the following link Idiotype Vaccines for CLL.

How time passes when we are not having fun. It is one year later, and we hope we are somewhat closer to our goal: an idiotype vaccine for CLL patients, after a Rituxan based pre-treatment to reduce tumor load. This approach, non-chemo pre-treatment with Rituxan followed by patient specific vaccine to eradicate the minimum residual disease, is already in Phase-3 clinical trials for follicular lymphoma, by another company called Favrille. You can read more about this on Karl's excellent Lymphomation site.

I thought you might like to have access to Genitope's FAQ (frequently asked questions), as well as read PC's latest correspondence with the company. The good news is that Genitope is finally looking at Rituxan based pre-treatments, not just high dose chemotherapy combinations. But it is still only for NHL patients. I know, I know, this is about as much fun as watching grass grow, and patience is not one of my virtues either. I for one think there is significant potential in these idiotype vaccine approaches, they are seeing some good results in the follicular lymphoma trials. With any luck, we can convince them to include CLL patients as well in their inclusion criteria for the next round.

Be well.



To Donna Shu
Manager of Advocacy Development
Genitope Corporation

Dear Donna:

Thank you for the update on MyVax. The FAQs you have put together provides a good basic introduction to the subject. I am sure it will be most interesting to the patient community.

Chaya and I read with great interest the specifics of the Phase 2 trial now open for patient accrual, Genitope Protocol 2002-09. You might recall that we expressed a high level of interest in the use of Rituxan as the agent to reduce tumor load prior to the MyVax + GM-CSF therapy. The protocol synopsis for G2002-09 certainly seems structured that way. Perhaps this study will produce some answers on the efficacy of antibody treatment as opposed to traditional chemotherapy as the first step before the MyVax. We understand that this trial is enrolling only patients that have failed CVP from the prior closed trial, Genitope Study 2000-3, and therefore focused on NHL patients only. Nevertheless, the outcome will be of great interest to CLL patients.

We will, of course, be even more enthusiastic about a de-novo trial that pairs MyVax and GM-CSF as a chaser to Rituxan in CLL patients, pre-treated or otherwise. There was some general discussion of that at the Patient Advocacy Summit last year, but of course, no specifics. Do let us know if you have something like that in the works for MyVax. Details would be welcome.

CLL Topics is doing very well. Our online publication has seen rapidly growing readership ever since it was launched a year and a half ago. We are recording over 19,000 visits a month, approximately doubling over the last 12 months. We have just about hit our fundraising target for our first sponsored clinical trial, Project Alpha, to be run by the Mayo Clinic, Rochester, MN. At least as far as CLL is concerned, we do direct a lot of the traffic and patients seem very interested in getting our opinion about the clinical trials out there. High on our short list of favorable developments would be any vaccine protocol in CLL.

As Genitope gets closer to the mark in testing its technology in CLL, we will be happy to act as a sounding board on the protocol and/or in getting the word out to the patient community.

Please give our best to Dan, Diane, Bonnie and the rest of the Genitope team.


P. C. Venkat
Editor & Publisher

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