Ruboxistaurin News

[Guest guest]

(Note: I am posting this for information purposes - perhaps this may

help us with CMT also, who knows? ~ G )

Data Presented at AAN Show Improvement of Symptoms of Diabetic

Peripheral Neuropathy in Patients Taking Ruboxistaurin

As many as half of the 150 million people with diabetes worldwide suffer

from diabetic peripheral neuropathy

SAN FRANCISCO, April 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company

(NYSE: LLY) announced today that patients with diabetic peripheral

neuropathy (DPN) using ruboxistaurin, currently being investigated as a

treatment for diabetic microvascular complications, showed improvement

in symptoms of DPN. The Phase 2 data were presented during the 56th

Annual Meeting of the American Academy of Neurology (AAN).

DPN is a condition caused by microvascular (small blood vessel) damage

that affects nerves outside the brain and spinal cord -- primarily in

the hands and feet -- and can lead to foot ulcers and amputations. DPN

is the leading cause of non-traumatic lower-limb amputations among

people with diabetes in the United States. More than 80,000 amputations

due to DPN are performed each year. Sensory symptoms of DPN include

numbness, prickling, aching pain, burning pain, lancinating pain, and

allodynia (a condition in which ordinarily non-painful stimuli evoke

pain, such as a bed sheet touching a leg).

There is no prescription therapy in the United States currently approved

to target the underlying process of microvascular damage that leads to

DPN. Pre-clinical data show that ruboxistaurin is a specific inhibitor

of PKC Beta, an enzyme that has been implicated in the underlying

process of microvascular damage that leads to diabetic microvascular

complications.

" These early findings are an encouraging development for patients with

diabetic peripheral neuropathy, " said Vladimir Skljarevski, M.D.,

neurologist, senior clinical research physician and investigator for

Lilly's ruboxistaurin effort. " We are in the midst of several Phase 3

trials and hope to see continued evidence that ruboxistaurin positively

impacts nerve function and sensory symptoms of diabetic peripheral

neuropathy while being well-tolerated by patients. "

DPN is one of three serious diabetic microvascular complications, along

with diabetic retinopathy (affects the eyes) and diabetic nephropathy

(affects the kidneys). Ruboxistaurin is being investigated as a

possible treatment for all three diabetic microvascular complications.

Study Findings

In a year-long, double-masked, placebo-controlled, Phase 2 trial,

ruboxistaurin treatment was found to improve signs and symptoms of DPN

based on neurological examination, symptom score and quantitative

sensory testing. A total of 205 patients with type 1 or type 2 diabetes

with DPN were randomized to receive 32 mg or 64 mg of ruboxistaurin or

placebo. Patients taking 32 mg ruboxistaurin showed overall improvement

in relevant components of neurological examination and composite scores

of nerve function. While the 64 mg group also experienced improvement,

efficacy was not as significant.

Eighty-three patients who, at baseline, demonstrated clinically

significant symptoms of DPN, according to the Neuropathy Total Symptom

Score-6 (NTSS-6) test, were assessed for symptom improvement. (The

NTSS-6 questionnaire measures the frequency and intensity of six

positive sensory symptoms -- numbness, prickling, aching pain, burning

pain, lancinating pain and allodynia.) Both groups of patients who

received ruboxistaurin

demonstrated improvement (p=.065 for 32 mg; p=.015 for 64 mg).

Findings also showed that following one year of treatment, side effects

were equally distributed among experimental and placebo groups and that

ruboxistaurin was generally well tolerated by the patients. While no

cause and effect relationship was established between ruboxistaurin and

any event, the most common side effects seen in the trials were

diarrhea, headache, nasopharyngitis and cough.

Lilly, a leading innovation-driven corporation, is developing a growing

portfolio of first-in-class and best-in-class pharmaceutical products by

applying the latest research from its own worldwide laboratories and

from collaborations with eminent scientific organizations.

Headquartered in Indianapolis, Ind., Lilly provides answers -- through

medicines and information -- for some of the world's most urgent medical

needs. Additional information about Lilly is available at

http://www.lilly.com .

This news release contains forward-thinking statements that reflect

management's current beliefs about the potential for ruboxistaurin in

the treatment of symptoms of diabetic peripheral neuropathy. However,

as with any pharmaceutical under development, there are significant

risks and uncertainties in the process of development and regulatory

review. This product has not yet been proven safe and effective. There

are no guarantees

that the product will receive necessary regulatory approvals or prove to

be commercially successful. For additional information about the

factors that affect the company's business, see the company's filings

with the United States Securities and Exchange Commission. The company

undertakes no duty to update forward-looking statements.