By Randall Osborne
Anergen Inc., given back the rights to its T cell inhibitor vaccine by partner Novo Nordisk A/S, vowed to move ahead with its development.
The drug, AnergiX, is a selective down-regulator of T cells. It was being studied for multiple sclerosis, myasthenia gravis and Type I diabetes in a deal with Bagsvaerd, Denmark-based Novo that was extended for two years in 1996, when the collaboration was three years old. (See BioWorld Today, April 2, 1996, p. 1.)
Novo will reimburse Anergen for the cost of an ongoing Phase I trial of AnergiX against multiple sclerosis. The trial is expected to finish in the third quarter of this year.
Both companies said the return of AnergiX rights by Novo was due to the company's shift away from research into central nervous system disorders.
David Smith, vice president and chief financial officer of Anergen, said Novo has been "moving out of the central nervous system area for the past couple of years." Although encouraged by the drug's results, they decided that continuing "was not in the collective parties' best interest," Smith said.
To develop AnergiX for rheumatoid arthritis, Redwood City, Calif.-based Anergen is paired with Organon, of Oss, the Netherlands. Organon is the pharmaceutical unit of the Akzo Nobel Group, in Oss.
Anergen expects to file an investigational new drug (IND) application with the FDA late this quarter or early next quarter. "We're in the process of drafting that," Smith said.
Another rheumatoid arthritis vaccine, known as AnervaX, showed encouraging interim data late last year from a Phase II trial, and Anergen is seeking a collaborator to develop it. (See BioWorld Today, Nov. 10, 1997, p. 1.)
"The trial is done, and we're hoping to have final results out in three to four weeks," Smith said. A Phase IIb trial is planned for the third quarter.
DiavaX, another synthetic peptide vaccine, is designed to prevent Type I diabetes. "It's proceeding along [in preclinical trials], with an eye toward an IND late this year or the first quarter of 1999."
As of Dec. 31, 1997, Anergen had $8.4 million cash, with a net loss of $2.3 million for the third quarter of last year.
The company's stock (NASDAQ:ANRG) closed Tuesday at $0.938, down $0.375. *