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Alert Number 159

An Update on Harvey

Date: April 10, 2006

It seems many of you follow the adventures of our strictly hypothetical CLL patient "Harvey", so I thought I would give you an update on our hero. For newcomers to the Harvey saga, below are the links to the earlier chapters of the story. Any resemblance you notice between Harvey and my husband PC is strictly a figment of your own overactive imagination. Right.

Last we heard, Harvey had developed a serious case of hypersensitivity to Rituxan. No more “mouse juice” for him, ever! The experts opined that his adverse reaction to Rituxan could be due to the fact that this monoclonal is "chimeric", half mouse and half human components, and a different monoclonal that is entirely human may not have the same adverse effects. Since Harvey wanted to reserve the potent bullet of Campath for a later time, and he wanted to stick with monoclonal therapy if he could, there was left only one option: the new arrival on the scene, Genmab’s fully human monoclonal antibody, Humax anti-CD20.

This Danish monoclonal has just been in Phase I / II clinical trials for previously treated CLL patients in the U.S.A. In fact, our FDA has given this drug "fast track status", and we can hope to see it put through its paces rather more quickly as a result. There are rumors of a Humax + fludarabine clinical trial soon, along the lines of the more familiar Rituxan + fludarabine combination pioneered at Ohio State. An earlier article on our website reviewed the interim results of the single agent Humax clinical trial (see link below). Since this clinical trial was closed to further patient recruitment, Harvey found himself in a bit of a predicament. How does one get access to a drug that is not commercially available, and the next clinical trial may be too far into the future to suit his time frame?

This is where it helps to have a few friends in high places. As part of her continuing research, Harvey’s wife Serena had developed good contacts within the CLL research and expert community. As she brainstormed therapy options with them, Dr. Terry Hamblin suggested that perhaps Genmab can be persuaded to let Harvey have access to Humax anti-CD20, on a “compassionate use” basis. Serena is not one to let a good idea go to waste. A couple of quick emails back and forth, and much to Harvey’s amazement, they had approval from Genmab! It looked like Harvey was going to be able to indulge in more anti-CD20 monoclonal therapy after all, but without having to risk the mouse components of Rituxan. Talk about having your cake and eating it as well.

Getting the agreement from Genmab was just the first step. As Harvey and Serena soon found out, given our regulatory situation in the USA these days, importing a few grams of a monoclonal antibody to treat a cancer patient is a lot harder than smuggling in plutonium to build dirty bombs. Every conceivable agency (including the Department of Homeland Security) had to be consulted, incredible amounts of red-tape sorted out. Harvey’s local oncologist would not touch Humax therapy with a ten foot pole; her practice’s insurance would not cover using “experimental” drugs of any kind. Harvey’s CLL expert, “Doc”, tried valiantly to get the regulations sorted out so that Humax could be administered at his expert center. After a month of hard work and gnashing of teeth, it became obvious there were just too many hurdles to getting Humax therapy for Harvey in the USA within a reasonable timeframe, even as an act of compassion.

I am delighted to report that our own Dr. Hamblin stepped into the breach yet one more time. As we speak, Genmab has shipped the drug to the attention of Dr. Hamblin in the UK, and Harvey & Serena have booked their tickets to fly to Bournemouth for the four weekly infusions of Humax anti-CD20. They are keeping their fingers crossed that the new drug will not trigger the same adverse reactions that Rituxan did, and that Harvey will get a nice long remission from it. The trip to UK and having the therapy administered there has turned out to be quite a bit more expensive than they imagined, but they are grateful that they have the option!

While this is a one-of-kind “compassionate use” of the drug, how Harvey responds to Humax is worth watching. For starters, it may be more effective than Rituxan, since it did give a higher percentage of complete responses in previously treated CLL patients. Secondly, it may be an option for patients like Harvey that develop adverse reactions to Rituxan. Last but not least, it is always a good thing for consumers when there are two products competing for their healthcare dollar. Perhaps Genentech, the owner of Rituxan, will be persuaded to spend a little more money doing good research on their mega block buster drug, if there is a new competitor on the horizon. Frankly, I was very pleasantly surprised by the patient responsiveness demonstrated by Genmab. Sure, the introduction from Dr. Hamblin helped open the door, but the company went through a major amount of paper work and red tape to allow Harvey access to their drug. Right there they get my vote for going the extra distance. I wish more companies had the patient responsiveness demonstrated by Genmab in this instance.

This is a surprising coincidence, but it turns out that PC and I will be traveling to the UK as well, and therefore I will be able to continue giving you an update on Harvey’s progress. Since PC and I will be at Bournemouth for little over 3 weeks starting from April 18th through May 9th, perhaps we will have a chance to meet with some of our UK members as well, at least those that are in the same neck of the woods. I am told I might even have a chance to speak at the UK CLL Forum meeting on the 4th of May.

Here are the links to the Harvey series, as well as our earlier review of the HuMax-CD20 interim results. I will write a full length article after Harvey has finished his therapy and update you on how he responded to Humax therapy.

Genmab's Clinical Trial

Harvey's Saga:
Harvey Is Back
Rituxan Road Block
Remission Management for the Round-headed Kid
Harvey's Chocolates
The Continuing Saga of the Round-headed Kid
The Difficult Case of the Round-headed Kid

Be well,

Chaya
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