CML Combo/Trials...The cure we have been waiting for?

[Guest guest]

Jerry Posted this on his CMLNEWDRUG.COM website.

CML Combo/Trials...The cure we have been waiting for?

by Jerry Mayfield

Yesterday (March 17, 2010), I met with Dr. Talpaz about his Combo trials.

The purpose of this post is to share information about these trials with you

all.

First, I want to share with those who are new to CML, a little background

about Dr. Talpaz. Over the last 30 plus years, first at M. D. and

now at the University of Michigan Medical Center, Dr. Moshe Talpaz has been

doing research and treating thousands of CML patients. During that time, he

has become world renowned as a researcher and pioneer in the treatment of

CML. He was the first to prove that Interferon could be used effectively in

the treatment of CML. He was one of the original three doctors to first use

Gleevec in the treatment of CML. He was one of the first two doctors to use

Sprycel to treat CML. He regularly travels the world to lecture about the

latest research and treatment for CML. Some call him " The Guru of CML " . He

is certainly a superstar in the world of CML research and treatment.

I have known Dr. Talpaz for 11 years now and I have never seen him more

excited about the prospect of finding a cure for CML. For the last several

years he has talked to me about the prospect of combining the proven immune

stimulation of Interferon with the effective targeted killing of CML cells

by the new tyrosine kinase inhibitors (TKIs) and how these combos might

bring a cure for many CML patients. He is now conducting a

Gleevec/Interferon trial and plans a Sprycel/Interferon trial to start in

the next three months. He has further plans to combine Interferon with

Tasigna and also Bosutinib if it gains FDA approval. Another possible

pathway to a cure that he wants to trial is combining TKIs with Hedgehog

Pathway Inhibitors. Some of these Hedgehog Pathway Inhibitors target the

primitive stem cells that cause CML. These primitive stem cells are not

eliminated by the current drugs used alone. All this is very exciting stuff.

For as long as I have known Dr. Talpaz, he has always had an uncanny ability

to look at the preclinical data about a drug and predict whether it will be

a major player in the CML world. This ability has put him at the forefront

of CML research. I have never seen him more excited about a prospective

trial. He is literally bubbling over with optimism that this strategy will

bring us the cure that we have been waiting for. We should all be very

hopeful for the future.

Here are answers to some questions about Dr. Talpaz's Combo Trials:

1. How do these trials work? Patients take the drug combination for two

years then stop all CML drugs and are monitored by PCR to see it they remain

CML free.

2. Do I have to be PCRU? No you do not have to be PCRU. A three log

reduction defined by Dr. Talpaz as a PCR result if 0.100% or below is

required to participate.

3. How much of my time will it take? After the first visit, another in 3

months and after that every 6 months or yearly.

4. Will I have bad side effects form the interferon? No, the dose of

pegylated Interferon used in the trial are miniscule, just a small fraction

of a normal dose. Most patients do not have any significant side effects.

5. Are there any other trial centers? No, these trials are located at the

University of Michigan in Ann Arbor Michigan. There may be other doctors

around the world doing similar trials but I do not have the information

about them.

6. How do I get more information? Doctor Talpaz requests that you contact

him directly by email at mtalpaz@... Please include these words in

your subject line " CML Combo Trials " .

All this is very exciting but it can't happen without your help. Patients

must be recruited then remain on the trial for two years before stopping the

drugs. Then they must be followed for several years in order to obtain the

data needed. This is a long process and for the trials to be valid, there

must be a substantial number of participants. Dr. Talpaz says that so far

recruitment has been slow. He has devoted his life to CML. His dream is to

find the cure. This is our chance to help him and at the same time to help

ourselves and the CML community world wide. Please consider doing your part.

Regards,

Jerry

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

3.8 log reduction Aug/09

4.0 log reduction Dec/09

e-mail: zmiller@...

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

Tel in FL: 561-429-5507