Guilford plans flurry of activity late in '99

Company readying 2 new treatments for human trials

European test also set

Firm will move scientific employees into new facility

Pharmaceuticals

June 01, 1999|By Mark Guidera | Mark Guidera,SUN STAFF

Guilford Pharmaceuticals Inc., the Baltimore-based biotechnology outfit, expects a whirlwind of activity in the second half of the year.

The company is seeking to move two new experimental treatments -- one for ovarian cancer and one for chronic pain and peripheral neuropathy -- into clinical trials late this year or early next year.

And biotechnology giant Amgen Inc. of Thousand Oaks, Calif., is expected to begin human trials of Guilford's experimental compound, known as NIL-A, in Europe this summer, said Stacey Jurchison, a Guilford spokeswoman. U.S. trials are expected next year.

Amgen plans to see if the drug is useful in treating Parkinson's patients. NIL-A, which Guilford licensed to Amgen in 1997, is based on molecules known as neuroimmunophilin ligands, which have shown remarkable promise in slowing progression of the disease in animal tests.

"The second half of the year is looking very active for us," said Jurchison.

Also on the plate for Guilford: moving its 120 scientific employees into a new 73,000-square-foot research and development facility in the summer. Meanwhile, the company expects to complete signing up patients in the summer for a human trial of Gliadel, its implantable bio-degradable wafer for late-stage brain cancer, the company's chief executive officer,

Craig Smith, disclosed to analysts recently.

The company and marketing partner Rhone Poulenc Rorer are conducting the trial to gather data so it can seek regulatory approval to market the wafer as a first-line treatment for glioblastoma multiforme, a common and deadly form of brain cancer.

Gliadel is approved in the United States, Canada and European markets for use in treating the cancer after tumor surgery. Guilford, which lost $8.5 million on $2.9 million in revenue in the first quarter, has been paid $1.7 million in royalties on Gliadel sales this year by Rhone Poulenc Rorer, which holds worldwide marketing rights.

The company is hopeful that sales and royalty payments will rise if Gliadel receives clearance for an expanded use.

As for Guilford's experimental treatment for ovarian cancer, Paclimer, the company expects to file an investigational new drug application (IND) with the Food and Drug Administration by December, said Jurchison.

If approved by the FDA, the treatment could be in safety studies by early next year.

Paclimer is an injectable solution loaded with a powder made with "micro-spheres" of a form of Taxol, a potent anti-tumor agent that has had blockbuster sales success. Guilford hopes to show that its targeted treatment minimizes adverse side effects of the drug.

The company also may file by the end of the year an IND for an experimental treatment that has neuro-protective and analgesic properties. The company, however, has a "superior" second-generation compound that is still being tested in animals, said Jurchison.

The compounds aim to prevent the release of an enzyme associated with cell death, known as NAALADase, hence they are known as NAALADase inhibitors.

Guilford plans to study their effect in treating patients with chronic pain and peripheral neuropathy, which causes pain and numbness in the limbs. Both are potentially huge markets.

The company is weighing whether to move an early NAALADase compound into human studies this year to show that the compounds are safe, or to delay safety studies until a more promising second-generation treatment is ready for human testing, said Jurchison.

"At this point it is 50-50 which way we will go. But we are in a position to take the prototype into the clinic this year," she said.

Pub Date: 6/01/99

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