RESEARCH TRIANGLE PARK–Incara Pharmaceuticals Corp. (OTC:INCR) said it has selected its catalytic antioxidant AEOL 10150 for late-state pre-clinical development. The company’s survival depends upon success of this, it’s only remaining pipeline product.

Incara, which saw its stock price collapse after its lead drug for heart disease failed in late stage clinical trials in 1999, has struggled since. It divested three other experiemental drug programs and only recently closed a company-saving $3 million financing.

Incara VP W.Bennett Love tells Local Tech Wire the company is down to about a dozen employees from a high of about 30 five years ago.

The company is developing the drug as a treatment for amyotrophic lateral sclerosis (ALS, commonly known as Lou Gehrig’s disease). ALS, the most common motor neuron disease, results from progressive degeneration of motor neurons. It is usually fatal within five years of diagnosis.

Incara says it intends to file an investigative new drug application with the U.S. Food and Drug Administration(FDA) in the second quarter of 2004, if animal safety studies go well. It said it must also complete the remaining component of a recently announced financing.

Powerful Antioxidant

If the FDA allows the IND filed by Incara, the company could initiate clinical trials to test the treatment’s ability to extend the survival time of ALS patients.

The company’s antioxidant compound, which is thousands of times more powerful than supplements such as vitamins C or E, has shown efficacy in animal models of ALS and other neurodegenerative diseases. In mice, the treatment extended survival time by 2.5 times. Untreated mice experienced increased disability daily, while the treated animals remained only mildly disabled until days before death.

“In addition to potentially filling an important medical need, a positive effect on ALS progression would suggest utility of our catalytic antioxidants in other progressive neurodegenerative diseases, such as Alzheimer’s disease,” says Richard E. Gammans, Ph.D., executive vice president of Incara.

Troubled Company History

The antioxidant program is Incara’s only remaining shot at survival since it divested its programs in liver stem cell research and other treatments. Incara is now focused on this new class of disease-modifying small molecules, the catalytic antioxidants.

Oxygen derived free radicals are one step in neuronal death resulting from a variety of causes. Incara’s experimental antioxidant treatment reduced damage in animal studies for both neurological disorders and in non-neurological indications, such as cancer radiation therapy, chronic bronchitis and asthma.

The company has struggled since late stage trials for its lead drug, Bextra, a treatment for heart disease, did poorly in late stage clinical trials.

Incara stock sold at $15 a share in 1996. It plunged 72 percent to $1.31 from $3.43 when Bextra showed no significant survival advantage to heart patients and the government stopped the trial in July 1999.

At that time, it had four other experimental treatments in the pipeline, none near clinical trial stage. Irish drug giant Elan supported another of the company’s efforts, but then Elan found itself in trouble and dumped many of its outside research deals.

The company’s stock price continued to fall. Incara was delisted from Nasdaq July last year and shuttled over to the Over-the-Counter Bulletin Board when its stock price fell below $1 for longer than the exchange allows.

Love and other employees of Incara worked without pay for about five months, but are being compensated again now. “It’s like a startup and in biotech you see a lot of it,” says Love. “If people believe in what they see in the future (for the company) they come in.”

Additional Funding Needed

The company recently closed on a bridge loan facility of $3 million. It also signed a nonbinding letter of intent for an additional $5 million in funding, subject to satisfactory completion of a toxicology study of the antioxidant and other conditions.

Love says the company “Does not expect any trouble with the toxicology tests, but that’s why you do the experiments.”

Completion of these financings is expected to provide sufficient funds to complete one or more Phase 1 clinical trials for AEOL 10150.

Incara stock closed at 12 cents a share Thursday.