FDA Grants Approval For Topical Non-Steroidal Treatment

Ceragenix Pharmaceuticals, Inc., announced it has received 510K clearance from the FDA for its EpiCeram Skin Barrier Emulsion to improve dry skin conditions and relieve and manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions by maintaining a moist wound and skin environment. This topical, non-steroidal treatment that consists of a specific combination of lipids will be available by prescription only.

The Facts On Baby Eczema

If your baby has an itchy skin rash the problem may be eczema (also called atopic dermatitis). Baby eczema can crop up on a baby's cherubic skin when a child is as young as 2 months old. It generally appears on the forehead, cheeks, or scalp and sometimes spreads to the arms or chest. The rash often shows up as dry, thickened scaly skin, but is sometimes made up of tiny red bumps that may ooze or become infected if scratched. Eczema is thought to be a reaction to allergy-causing substances in the environment. About 10 percent of infants have eczema at some point, but many improve before they're 2 years old. Because the condition is often inherited, your child is more likely to develop eczema if you or some other close family member has any kind of allergic condition, says Amy Paller, professor of pediatrics and dermatology at Northwestern University Medical School in Chicago.

Connetics Dermatitis Drug Succeeds On Second Trial

Connetics Corp. said its experimental drug for seborrheic dermatitis, which had been rejected by U.S. regulators due to concerns about its effectiveness, showed favorable results in another late-stage trial.
The U.S. Food and Drug Administration in November 2004 rejected the product, called Extina, after it failed in an earlier Phase III trial to prove superior to a placebo foam for the condition.
In the latest four week trial, however, Connetics said 56 percent of patients treated with Extina had an improvement in symptoms, compared with 42 percent of those receiving the placebo foam, a difference that was highly statistically significant.

Cobalis Drug Enters Phase III Clinical Trials

Cobalis Corp. (OTC BB: CLSC), a pharmaceutical development company specializing in anti-allergy medications, announced that the Company has successfully completed the enrollment of a total of 1,551 patients across two identical Phase III Clinical Trials of its anti-allergy medication PreHistin(R) in patients with moderate to moderately severe seasonal allergic rhinitis. The trials are being conducted at 23 sites across the central, southern and eastern United States.
It is expected that the ten-week trials will be completed in November. Cobalis expects to report final data from these Phase III Clinical Trials in the first quarter of 2007, followed by submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
Dr. Gerald Yakatan, Cobalis' CEO, said, "I am very pleased with the speed and efficiency with which the patient enrollment was conducted, and I believe it is a reflection of the breadth of the market opportunity we are addressing. I would like to congratulate our clinical team on a job well done. Assuming a favorable trial outcome, we plan to expeditiously prepare and submit the NDA.
These twin studies, consisting of 788 and 763 patients, are anticipated to fulfill the requirement for the two Phase III double blind, placebo controlled studies typically required for FDA approval.

Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy prevention medication. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US. For further information, visit www.cobalis.com