Cuban cancer drug undergoes rare U.S. trial

Posted on Saturday, 08.29.09
CUBA | MEDICINE
Cuban cancer drug undergoes rare U.S. trial
An `exciting' cancer drug developed in Cuba is being tested in the
United States -- but it won't be sold here unless there is a change in
the embargo law.
BY JOHN DORSCHNER
jdorschner@MiamiHerald.com

For the first time since Fidel Castro took power in Cuba over a
half-century ago, a drug developed by the Communist regime is going
through clinical trials in the United States.

The drug nimotuzumab is designed to target cancer cells including those
in rare and deadly types like glioma, the brain cancer that killed Sen.
Ted Kennedy. A researcher at the University of Florida, where one trial
is already in progress, calls the drug ``exciting, interesting.''

The hitch: Even if trials prove successful, nimotuzumab could not be
sold in the United States because 20 percent of the company holding the
license is owned by the Cuban government.

``We're in the business of developing drugs,'' said David G.P. Allan,
chief of YM Biosciences, based in Canada. ``We could care less about the
political side.''

YM Biosciences owns 80 percent of CIMYM, the company that has the rights
to develop nimotuzumab in North America, Europe, Japan and other places.
The other 20 percent is owned by the Center of Molecular Immunology, the
biotech lab in Havana that developed the drug.

Given by injection, nimotuzumab is already approved for marketing in 20
countries, including India and China, where the licensing was done
directly by Cuba, not YM. It is not approved in North America, Europe or
Japan, but almost 20 trials are in progress.

Amy Smith, a pediatric neuro-oncologist at the University of Florida,
said the theory is that nimotuzumab works by attacking epidermal growth
factor receptors, shutting off the growth of cancer cells.

Smith said early studies in Europe indicate the drug showed considerable
promise in prolonging the lives of children who have inoperable brain
stem glioma. Even with radiation, those children generally survive only
eight to 15 months.

To test the Cuban drug in the United States, YM needed an exception from
the embargo by applying to the Department of the Treasury's Office of
Foreign Assets Control -- a process that Allan called ``slow and formal.''

Other companies have done this -- Smithkline Beecham for a Cuba-made
meningitis vaccine, and CancerVax for a cancer vaccine. In both cases,
they obtained the necessary Treasury permission but after research
decided not to do clinical trials.

For nimotuzumab, YM received approval in 2006 for trials involving
children with inoperable brain cancer. Those tests are still
progressing. Results are expected next year.

Several drugs in the same class as nimotuzumab are already approved,
including Eli Lilly's Erbitux. These types of drugs do not lead to
miracle cures, said Allan, but can help extend life by allowing chemo
and radiation therapies to be more effective. YM maintains that
nimotuzumab is superior to others in its class because it alone does not
lead to toxic skin conditions.

Erbitux has a North American market of more than $1 billion a year,
Allan said, and is used with mixed results on a wide range of cancers.
For inoperable brain cancer cases, the U.S. market is about 5,000
patients -- not a large population for a drug manufacturer, especially
since treatments could cost $10,000 to $50,000 per patient.

That's why YM Biosciences went back to the Treasury and asked to import
the Cuban drug to test on patients with all sorts of cancers. That
approval came earlier this month.

Not all the nimotuzumab news has been positive. In March, the European
Medicines Agency rejected an application to market the drug, listing 27
major objections, including ``major deficiencies in the control,
consistency and validation of the drug substance'' at the Havana
manufacturing plant.

Allan said the application was made by a European company that had
sub-contracted with YM and was ``based on impoverished data'' which was
bound to be rejected. Next time, the application will be much sounder,
he said.

U.S. trials are expected to take three or four years. If the trials
succeed, YM would need a change in the embargo law.

Would a life-extending drug be worth an embargo exception? Ana
Carbonell, chief of staff for Rep. Lincoln Diaz-Balart, issued a
statement Friday, saying the Republican congressman from Miami
``supports all efforts to find cures for cancer.

``The medical trials for this drug will take several years. Diaz-Balart
hopes that by then the Cuban people will be free.''

Cuban cancer drug undergoes rare U.S. trial - Business - MiamiHerald.com
(29 August 2009)
http://www.miamiherald.com/business/story/1207536.html