Natural therapeutics company Aphios Corp. formed a new subsidiary to focus on finding and developing drugs to protect against influenza, including the current strain of the avian flu.

The new limited liability subsidiary is being called Amyxa Pharmaceuticals and will initially be housed at Aphios' Woburn, Mass., headquarters until it builds its own staff. The reason for forming Amyxa is simple: Worldwide concerns of an avian flu pandemic may signify a market opportunity for companies such as Aphios, but the actual development of a prophylactic or therapeutic treatment carries with it a great deal of risk.

With the creation of Amyxa, "the rest of the company is protected from any liability associated with that," said Aphios CEO Trevor Castor.

Aphios typically works with generic drugs that have established safety profiles. It develops new drug delivery formulations and creates enhanced versions of natural products, such as ginger.

Amyxa's plan is to create anti-influenza drugs from marine microorganisms and terrestrial plants that are protective against different strains of influenza A (including H5N1) and influenza B. Health authorities have expressed concern that the current strain of the avian flu (H5N1) could result in a pandemic if it is mutated and transferred human to human.

Each year, 40 million Americans develop the flu and as many as 40,000 die from it, but that number could rise drastically if preventive therapies are not in place, Aphios said.

The company said that nature is an excellent source of anti-influenza drugs. Amyxa will screen a library of marine microorganisms, isolated from normal to extremeophilic environments in U.S. territorial waters, and it will screen medicinal plants using its SuperFluids CXF fractionation technology.

So far, about 1,000 marine microorganism fractions - 2 percent of the marine microorganism library - have been screened against both influenza A and B in cytoprotection and cytotoxicity assays. Several fractions have shown activity against influenza A, and Aphios also has discovered an anti-influenza supercritical fluid fraction of a medicinal plant.

Castor said he hopes Amyxa will be in preclinical studies this year with a promising lead candidate and move into the clinic sometime next year. The product could enter a Phase I and then move rapidly into a Phase II/III trial.

"A drug like this can get accelerated clearance once it's proved to be safe," Castor told BioWorld Today.

Amyxa's products will be "very specific" for certain strains of the influenza A and B viruses, Castor said. Foster City, Calif.-based Gilead Sciences Inc.'s Tamiflu (oseltamivir phosphate) also is being studied as a treatment for the avian flu, but some safety questions recently arose when 12 Japanese children taking the drug for influenza died. Tamiflu, which is marketed by Basel, Switzerland-based F. Hoffmann-La Roche Ltd., is approved to treat uncomplicated influenza A and B in patients ages 1 and older, and also is used to prevent infection in high-risk patients, ages 13 and older.

The drug is a neuraminidase inhibitor that acts by blocking the viral enzyme to prevent the virus from invading cells in the respiratory tract. (See BioWorld Today, Nov. 21, 2005.)

Amyxa's strategy is to find natural sources of anti-influenza drugs, considering drug development companies such as Gilead have had success in that area. Fifty-two percent of the 1,031 new chemical entities approved between 1981 and 2002 were based on natural products, Amyxa said. The percentage rises when looking at anti-infectives: 68.5 percent were based on natural products. And of the 35 antiviral new chemical entities approved between 1981 and 2002, 71 percent, including Tamiflu, are naturally derived or based on a natural product molecule, it said.

Aphios is working to transfer its technology and research to Amyxa, which eventually will have its own staff and move to its own location. Currently, the company does not have any grants and is "being funded under internal resources right now," Castor said.

The name Amyxa is derived from two Greek words and means "free of influenza or free of mucus," Castor said.

In its own pipeline, Aphios is studying a number of natural products in the oral and intravenous forms, including SuperCool Gingerol for calming stomachs and healthy digestion; Zindol for chemotherapy-induced nausea, emesis, motion and morning sickness; SuperCool St. John for emotional well-being; Xantol for mild to moderate depression; SuperCool Palmetto for healthy prostate function and hair follicles; Sperol for enlarged prostate and male pattern baldness; LoTax and Taxosomes for breast and ovarian cancers; and Dermos for early stage Kaposi's sarcoma, melanoma and other cancers.

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