LOS ANGELES -- Scientists from Immunomedics Inc. reportedWednesday encouraging results from a 10-patient clinical testof its LL2 labeled monoclonal antibody product against B-celllymphoma.
"One patient had a complete remission, all disease undetectableafter therapy, for about one year, and this was for anextremely low dose of the agent," said Carl M. Pinsky,Immunomedics' vice president of medical affairs, told ameeting here of the Society of Nuclear Medicine.
Three patients given ImmuRAIT-LL2 showed a partialremission of up to 7.5 months, three patients showed lesserresponses, and four patients showed no response, according tothe Morris Plains, N.J.-based company. A partial remission wasconsidered a 50 percent reduction of the tumor for at least onemonth. Considering that most of the subject patients hadpreviously failed other therapies and that the optimal dose ofthe Immunomedics drug has not yet been established, a 30percent partial remission rate in this initial study is quitepromising, Pinsky said.
The ongoing Phase I/II study involves Immunomedics' LL2MAb labeled with the isotope iodine-131. Pinsky could not bereached for comment Wednesday concerning any side effects ofthe treatment.
Two other companies, ImmunoGen Inc. of Cambridge, Mass.,and Idec Pharmaceuticals Inc. of San Diego, appear to befurther along in clinical trials for therapeutics to treat B-celllymphoma.
Idec's Specifid therapeutic is expected to soon enter a pivotalPhase III study using a MAb sourced from Idec's Europeanpartner, Boehringer Ingelheim of Germany, Clifford Orent,Idec's senior vice president and chief operating officer, saidWednesday. The company has an ongoing Phase III studyinvolving about 45 patients.
ImmunoGen's immunoconjugate, Oncolysin B, entered clinicaltrials in 1988 and is about to start a Phase III multicenter trialthat the company believes could provide the data needed for aproduct licensing application (PLA) in early 1994, Mark Ratner,ImmunoGen's director of external communications, saidWednesday. Oncolysin B, the company's lead product, isadministered after a patient undergoes bone marrowtransplant.
"The competition to us is really conventional chemotherapy,"Ratner said of the expected therapeutic market for treating B-cell lymphoma. The incidence of B-cell lymphoma cases is onthe rise. It is diagnosed in about 32,000 new cases a year in theUnited States, with an increasing incidence in AIDS patients.
In addition to its LL2 MAb labeled with iodine-131,Immunomedics is also placing some its hopes on ImmuRAIT-Rhenium, a MAb linked to the rhenium-188 isotope. Thecompany hopes to get the product, which is considered easierto produce and offering deeper penetration than I-131, intoPhase I/II trials by the end of this year.
Immunomedics stock (NASDAQ:IMMU) closed Wednesday down50 cents a share at $8.13.
At a financial meeting here on Tuesday, Immunomedics'officials outlined three primary objectives that the companyaims to achieve during the next three years. They are to makeregulatory filings, or obtain marketing approvals, for six cancerimaging agents; make regulatory filings for ImmuRAID-MN3,an infectious disease imaging agent; and enter Phase III clinicaltesting for certain cancer therapeutics.
With about $50 million in cash and virtually no debt,Immunomedics faces no new financial need over the three-year period, said David M. Goldenberg, the company's chairmanand chief executive officer. "Our primary goal is to generaterevenues from the sale of the company's imaging products."
-- Ray Potter Senior Editor
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