FYI: Couple OF CML Articles

[Guest guest]

Hi all,

Here are a couple of articles about CML from the Wall Street Journal

that you may be interested in.

~ G.

www.cmlsupport.com

Leukemia Tests Take New Approach

Blood-Plasma Assessment

Could Eliminate the Need

For Painful Marrow Biopsies

By DARREN MCDERMOTT

March 28, 2006; Page D4

A new method of testing for leukemia and other blood-related cancers

offers hope that patients may benefit from more-sensitive assessments

that can be performed more frequently, eliminating the need for some

painful bone-marrow biopsies.

The set of tests, developed by Quest Diagnostics Inc. and now available

to doctors, takes a new approach to testing for some forms of leukemia

and lymphoma -- cancer of the blood and lymph system. Instead of

extracting cancerous cells from tissue inside patients' bones, these

tests check the blood plasma for telltale debris from cancer cells.

" What we are seeing now is you don't need to see the cells; you can look

in the plasma because the plasma has the fingerprint of the cells, " said

Maher Albitar, Quest's medical director for hematopathology.

Because the tests are conducted on blood samples, they can be performed

as necessary without subjecting the patient to painful and expensive

extraction of marrow, performed by a large-gauge needle inserted into

the bone.

Many aspects of the test are still unproven, and they apply only to some

forms of rare leukemia and lymphoma. Even Quest executives acknowledge

that doctors will need to physically examine cancer cells extracted from

patients' bone marrow -- particularly to make initial diagnoses -- for

the foreseeable future. But as the company develops tests for more

mutations associated with different forms of cancer, that could change,

says Dr. Albitar.

" This is just the beginning. From a scientific perspective, the finding

that these markers are traceable...frees you up from many of the more

arduous techniques when you're looking for tumor markers in the cells, "

said ph Schappert, vice chairman of pathology & laboratory medicine

at St. Luke's-Roosevelt Hospital Center and Beth Israel Medical Center

in New York.

In an announcement planned for today, Quest, Teterboro, N.J., is to

outline seven tests now available and another four coming soon. The

company's tests mark a new approach to detecting cancers of the blood.

Typically, doctors confirm a diagnosis of leukemia or lymphoma by

examining and testing cells extracted from bone marrow. Found inside

large bones, this tissue is what produces the body's blood cells,

including white cells found in the lymph system. But a bone-marrow

biopsy -- painful and expensive -- can sometimes produce an

unrepresentative sample.

The new tests detect the presence of proteins and genetic material that

spill into the blood when cancer cells die. The tests target specific

mutations or abnormalities, which can help diagnose particular forms of

cancer. In some cases, the tests can not only detect the presence of

cancer cells but measure their prevalence.

In a set of studies presented at an American Society of Hematology

conference in December, scientists from Quest and M.D. Andersen Cancer

Center at the University of Texas in Houston said that some of their

tests can quantify the magnitude and level of activity of a cancer in a

way that some current tests can't. That is important as the fight

against cancer shifts to using drugs that are narrowly targeted at

particular disease strains.

" Increasingly, if we know the genetic mutation [associated with the form

of cancer], then it's possible to devise a test like this to follow the

effect of therapy. But all of these tests aren't of equal utility or

importance, " said Marshall Lichtman, executive vice president of

research and medical programs at the Leukemia & Lymphoma Society and a

professor at the University of Rochester's School of Medicine.

One test likely to find wider use in the short term detects mutations

associated with resistance to Novartis AG's Gleevec in patients with

chronic myeloid leukemia. Diagnosis of the disease, which affects about

5,000 new patients each year, will still require physical examination of

cells and their chromosomes taken through a bone-marrow biopsy.

But for thousands of patients who are taking Gleevec, a remarkably

effective chemotherapy against CML, Quest's tests may prove useful.

Although there is currently a test for Gleevec resistance that can be

conducted on blood cells, company scientists presented findings

demonstrating that its plasma-based tests were more sensitive in

detecting the drug-resistant mutation and assessing response to therapy

than current methods.

Some of the tests have already won a following among doctors. " My

thinking has clearly changed " about testing, says Raju, a medical

oncologist at Kettering Medical Center in Kettering, Ohio, adding that

other doctors in his group have adopted Quest's plasma-based tests as

standard practice.

Write to Darren McDermott at darren.mcdermott@...

Novartis, SGX

Pair Up to Develop

Leukemia Drugs

By RON WINSLOW

March 28, 2006; Page D3

Novartis AG and SGX Pharmaceuticals Inc. entered a collaboration

agreement to develop new drugs for patients with chronic myelogenous

leukemia who develop resistance to Novartis's blockbuster treatment

Gleevec.

The pact reflects intensifying interest among drug companies to develop

next-generation medicines intended not only to combat

treatment-resistant cancers but eventually to become first-line remedies

that would likely be used in combination with Gleevec or other drugs.

CML is a kind of blood cancer that generally affects adults. About 4,600

new cases are diagnosed in the U.S. each year.

" We recognize that CML isn't one disease, " said Epstein, president

and chief executive officer of Novartis's oncology unit. " There are

subsets of patients and they need different types of therapies. You'll

see a series of novel drugs come to market. "

Gleevec, launched nearly five years ago for what was initially expected

to be a small market, has mushroomed into a huge drug, accounting for

$2.2 billion in global sales last year, largely as a treatment for both

CML and for a stomach cancer called gastrointestinal stromal tumor.

Currently Novartis and Bristol-Myers Squibb Co. both have new drugs in

mid-stage clinical trials for CML patients who either fail or relapse on

Gleevec. But neither one is effective against a particularly tricky

tumor mutation known as T315I that in some studies turns up in about 20%

of CML patients.

SGX Pharmaceuticals, a San Diego biotechnology company that went public

Feb. 1, has developed several compounds that in lab studies are

effective against a range of CML strains, including the standard one

Gleevec treats and the T315I mutation.

" We felt that collaboration with a major pharmaceutical company was the

best way of getting a promising new drug " to the market quickly, " said

Grey, president and chief executive.

Under terms of the agreement with Novartis, SGX will receive $25 million

up front with future payments that could reach a total of $515 million

if all milestones are successfully met. In addition Novartis is

acquiring a small stake in the company. If a drug reaches the market,

SGX would receive additional royalty income.

The agreement underscores fresh advances in understanding how tumors

develop resistance, said Druker, Medical Institute

investigator at Oregon Health and Science University, Portland, who

pioneered Gleevec's development as a treatment for CML. " In the long run

we may combine drugs to prevent resistance from happening to begin

with. " Dr. Druker is on the scientific advisory board of SGX and has led

clinical trials for Novartis and Bristol-Myers.

The companies plan to choose a drug candidate to take into human

studies, which are expected to begin next year. While odds are long in

general for compounds effective in the lab to clear all hurdles

necessary for regulatory approval, if all goes well, the companies

believe a drug could be on the market before the end of the decade for

patients who don't respond to or develop resistance to Gleevec.

Write to Ron Winslow at ron.winslow@...