Data Presented at ADA Show Physicians Identify That Ruboxistaurin Mesylate Improves Symptoms of Diabetic Peripheral Neuropathy
14 Jun 2003, 3:15pm ET
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More than half of the 150 million people with diabetes worldwide

suffer from diabetic peripheral neuropathy

NEW ORLEANS, June 14 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE:LLY) announced today that patients with diabetic peripheral neuropathy treated with ruboxistaurin (PKC ? Inhibitor, LY333531) mesylate showed improvement in Clinical Global Impression (CGI) -- a globally accepted assessment tool used by physicians to measure patient's overall well being at the conclusion of a study. CGI ratings showed the greatest correlation with improvement in patient symptoms. The Phase 2 data were presented during the 63rd Scientific Sessions of the American Diabetes Association (ADA).

Diabetic peripheral neuropathy is a complication associated with underlying microvascular damage that affects nerves outside the brain and spinal cord -- primarily in the hands and feet -- and can lead to foot ulcers and amputations. Symptoms of diabetic peripheral neuropathy include numbness, prickling, aching pain, burning pain, lancinating pain, and allodynia (a condition in which ordinarily non-painful stimuli evoke pain). Pre-clinical data show that ruboxistaurin is a specific inhibitor of PKC ?, an enzyme that has been implicated in the underlying process of microvascular damage. There is currently no prescription therapy approved in the United States to treat the symptoms of diabetic peripheral neuropathy by targeting the underlying process of microvascular damage.

"This Phase 2 data analysis is important not only because of the improvement shown in subjective symptoms and objective signs including vibration detection threshold and the neurological examination in the ruboxistaurin-treated group, but because the physicians reported seeing an improvement in the general well-being of the patient following ruboxistaurin treatment," commented Edward Bastyr III, M.D., senior clinical physician for the ruboxistaurin effort at Lilly.

Study Results

A total of 205 patients with type 1 or 2 diabetes with diabetic peripheral neuropathy were randomized to receive 32mg or 64mg of ruboxistaurin or placebo. In the one-year, doubled-masked, placebo-controlled trial, treatment with ruboxistaurin was found to improve symptoms of diabetic peripheral neuropathy as assessed by Neuropathy Total Symptom Score - 6 (NTSS-6), a measure that evaluates the frequency and intensity of symptoms.

Treatment led to clinically significant improvements in CGI ratings (p = 0.044 vs. placebo). CGI improvement correlated with changes in NTSS-6, Vibration Detection Threshold (VDT) and Neuropathy Impairment Score (NIS) in Lower Legs (LL) with greatest correlation being with positive changes in five of six NTSS-6 measures, particularly burning pain (p<0.001) and prickling [p=0.008). An analysis indicated that total NTSS-6 score is the main predictor of CGI [p<0.0001).

Ongoing studies are investigating ruboxistaurin as a possible treatment for diabetic peripheral neuropathy, diabetic retinopathy (damage to the small

blood vessels of the eye), and diabetic nephropathy (damage to the small blood vessels of the kidneys), the three major diabetic microvascular complications.

Eli Lilly and Company, a leading innovation-driven corporation, is developing a growing portfolio of 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.

This news release contains forward-looking statements that reflect management's current beliefs about the potential for ruboxistaurin (PKC ? Inhibitor, LY333531) mesylate 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. The 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.

SOURCE Eli Lilly and Company
-0- 06/14/2003
/CONTACT: Morry Smulevitz, +1-317-651-5567, for Eli Lilly and Company/
/Web site:

http://www.lilly.com

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