Jerry Mayfield 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. Anderson 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@med.umich.edu 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