Dental Health :: Oragenics reports positive clinical results with its oral probiotic mouthrinse

Oragenics, Inc. (Amex: ONI) announced today that the first of two sets of subjects has completed a clinical trial utilizing its proprietary oral probiotic product, Probiora3(TM). The trial was designed to determine safety and the effectiveness of the mouthrinse against baseline levels of disease-causing bacteria in the mouth. Daily mouth rinsing with Probiora3(TM) resulted in substantial reductions in the numbers of the bacterium, S. mutans, which attacks teeth, as well as two target periodontal strains, Porphyromonas gingivalis and Campylobacter rectus, associated with gum disease and bad breath. The product was well tolerated by the subjects and no safety issues were identified with the twice daily use of the product over a two-month period.

Cancer :: Methoxyamine – new cancer therapy reverses resistance to chemotherapy

Case Western Reserve University’s Technology Transfer Office has entered a worldwide exclusive licensing agreement with TRACON Pharmaceuticals of San Diego, Calif., to develop Methoxyamine, a new cancer therapeutic that reverses cancer cell resistance to chemotherapy. Methoxyamine is a “first in class” drug that targets a specific DNA repair pathway.

Allergy :: Food allergies could be fought with friendly bacteria in alcoholic milkshake

Feeding babies alcoholic milk may help to protect against some food allergies. Kefir, a traditional fermented drink, is consumed in Eastern Europe as a health food, and is often used to wean babies, as it is easily digested. Food allergy prevalence is especially high in children under the age of three, with around 5-8% of infants at risk. Currently the only treatment is avoidance of the problematic food.

Neuroma :: Anesiva – orphan drug status for pain drug 4975 to treat interdigital neuroma

Anesiva, Inc. (Nasdaq: ANSV) announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug status to product candidate 4975 for the treatment of a painful condition in the foot known as interdigital neuroma in patients who fail conservative treatments, such as foot pads, NSAID’s (non-steroidal anti-inflammatory drugs) and injections of corticosteroids, that would otherwise require removing or chemically destroying the nerve that causes the pain. Orphan drug designation is granted by the FDA to encourage companies to develop products that treat rare diseases and conditions and includes incentives such as market exclusivity for seven years, tax credits on qualified clinical trial expenses and a waiver of the FDA prescription drug user fees.

Health :: Innocoll – collaguard – a collagen-based advanced wound care product

Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Pharmaceuticals, has received US 510k approval for CollaGUARD(TM), an advanced wound care product based on Innocoll’s proprietary CollaRx(TM) membrane technology. CollaGUARD is indicated for the management of superficial and deep wounds, including coverage of skin ulcers and temporary dermatoplasty in the case of lesion and burns. CollaGUARD has already received CE-mark approval for marketing in Europe.

Cancer :: Agennix receives fda orphan drug designation for talactoferrin alfa in renal cell carcinoma

Agennix today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s oral formulation of Talactoferrin Alfa (talactoferrin or TLF) for the treatment of renal cell carcinoma (RCC). Oral TLF is currently in Phase II clinical development for RCC. Results from a multi-center Phase 2 RCC trial that included six leading U.S. cancer centers were presented at the 2006 Annual meeting of the American Society of Clinical Oncology (ASCO).

Smoking :: Nabi biopharmaceuticals completes enrollment in nicvax phase iib ‘proof-of-concept’ clinical trial

Nabi Biopharmaceuticals (Nasdaq: NABI) today announced it has completed enrollment for its Phase IIB “proof-of-concept” study for NicVAX(R) (Nicotine Conjugate Vaccine), the company’s novel, innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse. Enrollment for the trial was completed three months earlier than anticipated, paving the way for the release of trial results early in the second quarter of 2007.

Brain Cancer :: Peregrine receives regulatory approval for Cotara brain cancer clinical trial

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a biopharmaceutical company with a portfolio of innovative, clinical stage products for the treatment of cancer and hepatitis C virus infection, today announced that it has received regulatory approval in India for a new clinical trial of its lead tumor necrosis therapy (TNT) agent Cotara(R). The trial is designed to test the safety and efficacy of Cotara in patients with glioblastoma multiforme, a deadly form of brain cancer. Cotara is currently being studied in a multi-center U.S. glioblastoma trial. Previous studies using Cotara to treat brain cancer have produced encouraging results, and Peregrine expects that positive data from this trial in combination with data from the ongoing U.S. clinical trial should provide the foundation for planning the future development and commercialization of Cotara.

Obesity :: Manhattan pharmaceuticals – oral oleoyl-estrone clinical program to include morbidly obese

Manhattan Pharmaceuticals, Inc. (Amex: MHA) today announced expansion of its oral Oleoyl-estrone (OE) clinical obesity program to include the morbidly obese. A new US Phase 2a clinical trial evaluating oral OE in morbidly obese male subjects will be initiated in October 2006. The morbidly obese population in the US is estimated to be 14 million people. OE is the Company’s orally administered product candidate in development for the treatment of obesity.

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