ImmunoGen Inc. said Monday it has started a Phase III clinicaltrial of its anti-cancer compound Oncolysin B for treatingpatients with non-Hodgkin's B-cell lymphoma.
The trial is designed to demonstrate the effectiveness of thedrug in extending the disease-free survival of patients who arein remission after autologous bone marrow transplantation(ABMT).
Although remissions after ABMT can be induced viachemotherapy and radiation, only 30 percent to 40 percent ofABMT patients (there are 36,000 new cases in the U.S. everyyear of non-Hodgkin's B-cell lymphoma) remain in remissiontwo years after transplantation, according to Carol Epstein, vicepresident and chief medical officer for ImmunoGen ofCambridge, Mass. She added that ImmunoGen intends to useOncolysin B, which is an antibody-conjugated toxin, "toeliminate the minimal residual disease which we know ispresent and which eventually leads to relapse."
In fact, ImmunoGen is hoping to use Oncolysin B for treatinglymphocytic leukemias, multiple myeloma and AIDS-relatedlymphoma, as well. "Because off-label use of cancerchemotherapeutics is widely accepted and is reimbursed bythird-party insurers, we anticipate that Oncolysin B willpenetrate the broader market of cancer patients with B-cellmalignancies rapidly," explained Donald McCarren, presidentand chief operating officer.
ImmunoGen had originally intended to initiate the multicenterPhase III trial by the end of last year, but was delayed due to acomplicated series of negotiations with the cooperativeoncology group that is conducting the trial, the Cancer andLeukemia Group B, a nationwide organization of cancer centers.
The company's announcement at the end of January that thesenegotiations were still not complete caused Hambrecht & Quistanalyst Wole Fayemi to downgrade his rating on the stock(NASDAQ:IMGN) to a "hold" from "buy" on Feb. 5. Fayemipushed his estimates of profitability on ImmunoGen back bythree years, to 1988. His pronouncement sent the stockplummeting by 24 percent in heavy trading that day; it settledat $7.25 a share, about where it has remained ever since.
Fayemi is still cautious, though he said the start of Phase IIItrials is "a significant positive milestone for the company."However, "given the current environment of overalluncertainty in the health care sector, as well as uncertaintyabout ImmunoGen's plans for commercializing the product, it'sprudent to wait (for a change in recommendation)," Fayemi toldBioWorld.
Joseph Edelman, an analyst who follows ImmunoGen forPrudential Securities, agreed that the start of Phase IIIs isimportant for the company. Edelman also has a "hold" rating onthe stock -- for the short term. "The long-term potential is veryhigh," Edelman told BioWorld. "They're using antibodies in away that makes sense. They're getting around two criticalproblems in cancer therapy: uptake into the tumor (lymphomasare blood-borne) and attacking a mass of cancer cells head-on(the immunotoxin targets residual cells)."
Other companies developing compounds for treating non-Hodgkin's B-cell lymphoma include Seragen Inc.(NASDAQ:SRGN), Idec Pharmaceuticals Corp. (NASDAQ:IDPH)and Immunomedics Inc. (NASDAQ:IMMU).
Seragen, of Hopkinton, Mass., has developed a fusion toxin thattargets the interleukin-2 receptors on chemotherapy-resistantlymphomas, including non-Hodgkin's. The drug, DAB389IL-2,entered Phase II clinical trials in chemotherapy-resistantpatients last October.
And Idec of La Jolla, Calif., in February submitted protocols toFDA for a pivotal Phase III trial on its Specifid panel of 15immunologically active antibodies for treating some types oflow-grade non-Hodgkin's B-cell lymphoma patients whosedisease has relapsed.
As well, ImmunoMedics of Warren, N.J., is in the clinic with aradioactive monoclonal antibody, ImmunRAIT-LL2, for treatingB-cell lymphoma.
ImmunoGen's stock closed unchanged Monday at $7.25 a share.
-- Jennifer Van Brunt Senior Editor
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