New Drug May Boost Platelet Counts

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Positive clinical trial results of investigational thrombocytopenia

agent

AkaRx, Inc. presents Phase I clinical data of AKR-501 at 48th

American Society of Hematology Meeting

ORLANDO, Fla., Dec. 11 -- AKR-501 is a promising member of a new

class of agents called, " TPO receptor agonists " that is now in Phase

II clinical development. It is an investigational orally

administered drug being developed by AkaRx, Inc. intended to mimic

the biologic effect of thrombopoietin, a growth factor that

stimulates production of platelets.

At the American Society of Hematology meeting, results from two

Phase I clinical research trials were presented. These data in

healthy volunteers showed that AKR-501 produced a 50% increase or

greater over the baseline platelet count. AKR-501 is the first oral

drug in its class to show these platelet increases with a single

dose. In the single dose study this was achieved at the 100 mg dose.

In all volunteers given multiple doses of either 10 mg or 20 mg for

10 – 14 days a platelet effect was observed where increases were at

least 50% over baseline.

The unmet medical need for AKR-501 is that there is no approved

agent to specifically stimulate megakaryocytes to produce platelets

to treat thrombocytopenia in the same way that there are products

available to stimulate production of red and white blood cells.

Severe thrombocytopenia is currently managed in some settings with

platelet transfusions. However, this temporary solution in not

suitable for long-term use in chronic settings and is often

associated with serious complications when used in acute situations.

AKR-501 imitates the body's mechanism for stimulating platelet

production by mimicking the action of thrombopoietin—the growth

factor that modulates this process.

" AKR-501 is a very promising candidate for use in the prevention and

treatment of thrombocytopenia in a host of diseases, among them,

ITP, Chemotherapy Induced Thrombocytopenia, and Hepatitis C

associated thrombocytopenia, " said E. Desjardins, MD,

President and CEO of the drug development company, AkaRx. " These are

the first clinical results of AKR-501 that show that it may be a

safe thrombopoietic agent with an impressive ability to stimulate

platelet production. This class may be a real breakthrough for

patients. These results for AKR-501 give us confidence to envision a

very broad clinical development program across the world for this

compound that appears to have great medical and commercial

potential. "

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