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Alert Number 181

Genitope Vaccine Trial: Developments

Date: August 1, 2006

The vaccine clinical trial announcement for CLL patients by Genitope has been received with great interest by our patient community. So much so that the patient recruitment happened in record time and this trial “sold out” very quickly. You can read our reviews of this technology by clicking on the links below. We like to think our reviews may have had something to do with the rapid recruitment for this trial.

Idiotype Vaccine for CLL;
Vaccine Trials.

But CLL has not been Genitope’s first venture into the realm of personalized/custom cancer vaccines. Way back in November of 2000 Genitope started a phase-3 trial in follicular lymphoma patients. This is a blinded and double arm trial – the experimental group of patients received the customized MyVax vaccine while the control group got a placebo. Even the patients do not know which group they are in, that is the whole point of a blinded study - to avoid biased results, since “beauty is in the eye of the beholder” and all that jazz.

Genitope was hoping that as this massive group of around 270 – 300 patients are followed over time, a clear and unambiguous difference would quickly emerge between the survival and progression of patients that got the MyVax vaccine and those that got a placebo. That did not happen. Last week Genitope announced that the independent data safety monitoring board has announced it is still too soon to see statistically significant differences between the two groups, and the trial has to continue at least until the end of the year. You can read excerpts from Genitope’s press release and some commentary from industry watchers below.

Running clinical trials is expensive business. Small biotech companies literally “burn” money as they go through the process of drug development and clinical trials, hoping that the technology-horse they have bet on will be a winner and make them incredibly rich down the road. But the process of getting from a good concept to fully proven therapy that gets regulatory approval and makes it to the marketplace is a tough struggle and sometimes the company does not survive. Its idea may still be a good one but if it needs too much tweaking or takes too long to show stellar results, the company could just plain run out of money as impatient venture capitalists walk away.

Something like this happened to Xcyte Therapies, Inc., the company that tried to commercialize its concept of large armies of T-cells grown outside the patient’s body and then re-infused back into the patient as a way of treating CLL. The clinical trials of this technology held at UCSD, M. D. Anderson and Dana Farber received a great deal of publicity and hype. You can read our reviews of this technology by clicking on the links below, as well as the first-person account of one of our members who participated in their trial. Last I heard, Xcyte Therapies, Inc. is no more.

T-Cell Therapy at UCSD - Details of Clinical Trial;
Arabella.

It now seems the business world is not too happy with Genitope’s inability to show robust positive effects of its vaccine in follicular lymphoma, even after 5+ years. The company's stock has tanked, losing roughly half its value in a single day last Friday. As we all know, money makes the world go round. Does this impact the future of the company, its ability to start new clinical trials or continue to completion the ones that it has already started? If I knew the answers to that and other similar questions, if my crystal ball allowed me to see how this and other companies would flourish or fold in the future, I would be making oodles of money on the stock market instead of pounding away on my laptop talking to you guys. Just kidding - the pay is lousy and the hours long, but this is the best “job” I have ever had.

Be well,

Chaya
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Company Press Release (excerpt):

Data Safety Monitoring Board Recommends Continuation of MyVax(R) Personalized Immunotherapy Phase 3 Trial After Second Interim Analysis

Conference Call to be Held Friday, July 28 at 9:00 AM EDT REDWOOD CITY, Calif., July 27 /

PRNewswire-FirstCall/ -- Genitope Corporation (Nasdaq: GTOP) today announced that its independent Data Safety Monitoring Board (DSMB) reviewed the second planned interim analysis of data for efficacy in its pivotal Phase 3 clinical trial for treatment of follicular non-Hodgkin's Lymphoma (fNHL) and recommended that the trial continue as planned. The clinical trial will be completed by December 2007. This trial evaluates the safety and efficacy of the company's lead product candidate, MyVax(R) personalized immunotherapy, in patients with previously untreated fNHL. The trial compares patients treated with MyVax(R) personalized immunotherapy to patients treated with a nonspecific immunotherapy control.

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News Report:

MyVax Misses Statistical Hurdle, Genitope Plunges

By Aaron Lorenzo

In a disappointing case of déj vu, investors drove down shares in Genitope Corp. by 48.6 percent after learning that a Phase III study of its lead cancer treatment would last longer than expected.

The news starkly mirrors that of a year ago, and on Friday, the stock (NASDAQ:GTOP) lost $2.71, to close at $2.87, an all-time low, on heavier-than-usual volume. Like last year, the company disclosed that its pivotal trial of MyVax would have to continue, this time until December 2007.

That was the recommendation of an independent data safety monitoring board following its second interim analysis of efficacy data in follicular non-Hodgkin's lymphoma patients.

"I think the reaction today is certainly rational," Jason Kantor, an analyst with RBC Capital Markets, said of the stock drop. Noting that there will be no more news drivers until the trial ends, "it's not a very attractive opportunity from that perspective."

Genitope Chairman and CEO Dan Denney admitted his "disappointment" during a conference call, acknowledging a hope "that we would cross the goal line" at this point. But the study has yet to reach a statistically significant difference to prove the personalized immunotherapy's merit relative to treatment with a nonspecific immunotherapy control.

"We don't know what's wrong with the trial at this point," Kantor told BioWorld Today. "There are no known facts here, except that they didn't hit the statistical hurdle - 0.0026."

The Redwood City, Calif.-based company will release some of the study's early findings this week as part of a government filing. Denney, who said there are "no red flags" in the data, added he remains "optimistic about the ultimate outcome" of the study.

Kantor also expects success in the end, noting the trial "will probably show a statistically significant benefit at the final analysis," but he questioned whether it would be as robust a response as was expected because the statistical assumptions going into the study have yet to be realized.

Also, he indicated he expects little clarity from this week's unveiling of data, predicting that while the findings might demonstrate a significant prolongation of progression-free survival in the entire patient population, there would be no clear insight as to MyVax's impact. That could lead to confusion, Kantor said, but he thinks the therapy "probably does work.'

Nevertheless, New York-based RBC downgraded Genitope's stock.

The company's disclosure a year ago that an initial interim analysis indicated that the study would have to continue was met with a similar reaction, causing a 27.9 percent plunge in the company's shares to $8.80. (See BioWorld Today, July 27, 2005.)

Between 270 and 300 patients are participating in the trial, which began in November 2000. Its continued duration has been of concern relative to Genitope's ability to cover costs. The company had $119.7 million in reserve cash, cash equivalents and marketable securities as of March 31.

Denney, who said "we've been very careful with our pennies until now," added it was too early to determine whether Genitope would need to raise additional funds next year. Looking back a bit, money has been brought in ahead of both interim analyses: A financing earlier this year netted about $58.7 million, and one before that raised $53.7 million. (See BioWorld Today, Dec. 15, 2004, and Feb. 8, 2006.)

Denney noted plans to start further MyVax studies could be delayed by as long as three months to further conserve cash, though he offered little transparency on the company's burn rate going forward. In addition to the Phase III work in follicular non-Hodgkin's lymphoma, for which the product has fast-track status from the FDA, there is an ongoing Phase I/II trial in chronic lymphocytic leukemia patients.

Published July 31, 2006

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