Zileuton + Glivec Phase I Trial Update

September 24, 2010

Hi to all my CML friends,

I've received an update concerning the Zileuton (600mg) + Glivec (400mg) Phase I

trial taking place at UMass, Amherst, MA. The below email was sent to me after

a phone call from Dr Cerny. He said I could share this with the CML community.

Dr Cerny also informed me during our phone conversation that the other four

participants are doing fine, and expects approval to continue soon:

**As Dr Cerny states in his email, please, please do not trial this on your own

at home.**

=====================================

Dear Mr. Adkins,

thank you for " reminding " me (Dr. Li actually) that I have not gotten back to

you. My apologies! We have open the trial and have recruited first few patients.

One of the patients have developed possibly related grade 4 toxicity. We have to

follow stopping rules of the trial and also our IRB rules. We put the accrual

of new patients on hold. Hence some of you may have noticed the change on the

website. We are awaiting the word from safety monitors (or DSMB). My plan is to

continue with the study as soon as possible, I will let you know. I am greatly

touched by all of your support and interest in this research. I am as anxious as

everyone else and can't wait for all the results. But I want to make sure that

we can proceed safely with accrual of new patients. Unfortunately, we have to

wait.

**I would also strongly recommend that nobody tries this treatment " at home " . As

much as we want to find cure, we want to make sure it is done safely and

everything is recorded.** Sometimes small nuances make a big difference. That is

why we have to do clinical studies under research protocol. Now to your second

point/question, I have asked personnel from our development office to open an

account for our research. This fund would serve as an assistance to patients who

e.g. need long distance travel. Our resources are at this moment limited to the

clinical and laboratory research related expenses.

Thank you very much for your inquiry, I will be happy to make a follow up phone

call.

Jan Cerny, MD, PhD

Assistant Professor of Medicine

Division of Hematology/Oncology

Department of Medicine

University of Massachusetts

55 Lake Avenue North

Worcester, MA 01655

Tel.: 774-442-3903

Fax.: 774-443-7890

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