Genta Inc. said Wednesday that it filed an investigational newdrug (IND) application with the FDA for G-301, a topical versionof patented treatment for psoriasis that is already marketedfor oral delivery.

G-301 is one of five conventional drug products that Genta haslicensed to fill its near-term product pipeline while it continuesdevelopment of several therapeutics based on antisensetechnology.

Topical delivery of G-301 is designed to concentratemethotrexate in the dermal and epidermal layers of the skin,where psoriatic cell growth takes place. It is also intended toovercome problems of kidney and liver damage associated withoral administration of methotrexate. The drug has been showneffective in slowing down rapidly growing cells in severe casesof recalcitrant psoriasis.

"We believe that by applying G-301 topically, most if not allthe methotrexate will go into the skin, where it will exert itstherapeutic action against psoriasis and not achieve a highserum concentration," Genta spokesman Bill Albright toldBioWorld.

Albright said the San Diego-based company expects G-301 willenter clinical trials soon after the customary 30-day periodfollowing the FDA application. It also plans to conduct Phase IItrials of the compound in Europe this fall.

Genta in June filed an IND to start clinical trials of G-101, atopical acne treatment and another of the five near-termproducts that are expected to help sustain the company's salesforce until antisense products arrive.

Antisense and triple-strand control technologies aimed atinhibiting expression of unwanted proteins are the basis for thecompany's ultimate growth strategy. Among a broad range ofpotential treatments, Genta hopes to file an IND late this yearon an antisense compound designed to treat psoriasis byslowing the overproduction of interleukin-1.

-- Michelle Slade Associate Editor

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