An interesting (and amusing) post from Chaya

[Guest guest]

Hello Folks - here is a fascinating post from of clltopics.org. We got

her permission to post it to our group. Something for us to learn.

TOPICS ALERT Number: 159

Date: April 10, 2006

It seems many of you follow the adventures of our strictly hypothetical CLL

patient “Harveyâ€, 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

“

chimericâ€, 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 statusâ€, 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 researcher 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 useâ€

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

“Docâ€

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

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 getting the therapy there has turned

out to

be quite a bit more expensive than they imagined, but they are grateful that

they had 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 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. ly, 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 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 interim results. I will write a full length article after

“Harveyâ€

has finished his therapy and update you on how he responded to Humax therapy.

Genmab clinical trial:

_http://www.clltopics.org/ClinTrials/HuMax.htm_

(http://www.clltopics.org/ClinTrials/HuMax.htm)

Harvey saga:

_http://www.clltopics.org/Rituxan%20Basics/RituxanRoadBlock.htm_

(http://www.clltopics.org/Rituxan%20Basics/RituxanRoadBlock.htm)

_http://www.clltopics.org/CI/Continuing%20Saga%20of%20the%20RHK.htm_

(http://www.clltopics.org/CI/Continuing%20Saga%20of%20the%20RHK.htm)

_http://www.clltopics.org/Case%20Studies/RHK3.htm_

(http://www.clltopics.org/Case%20Studies/RHK3.htm)

_http://www.clltopics.org/Case%20Studies/RHK4.htm_

(http://www.clltopics.org/Case%20Studies/RHK4.htm)

_http://www.clltopics.org/CI/The%20Difficult%20Case%20of%20the%20Round-headed%

20Kid.htm_

(http://www.clltopics.org/CI/The%20Difficult%20Case%20of%20the%20Round-headed%20\

Kid.htm)

Be well,

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[Guest guest]

,

Thank you so much for posting this!

I'm looking forward to hearing about the results of " Harvey's " treatment

with Humax anti-CD20.

I wish " Harvey " the best outcome possible for his sake and for the sake of

the rest of us who may one day benefit by Humax anti-CD20.

Andy

An interesting (and amusing) post from

Hello Folks - here is a fascinating post from of clltopics.org. We

got

her permission to post it to our group. Something for us to learn.

TOPICS ALERT Number: 159

Date: April 10, 2006