Corixa Corp. and its research partner, Genesis Research and Development Corp. Ltd., on Thursday released data from overseas trials of the injectable psoriasis treatment, PVAC, showing clinical activity and safety but a missed endpoint.
Jim DeNike, a spokesman for Seattle-based Corixa, characterized the Phase II results as "expected" and consistent with results from a previous U.S. trial that failed to meet its primary endpoint. (See BioWorld Today, Feb. 16, 2002.)
Wall Street reacted as though the news was expected. Corixa's stock (NASDAQ:CRXA) fell 8 cents Thursday to close at $8.48.
The largest of the overseas trials, a 165-patient study conducted in Brazil that compared two doses of PVAC with placebo, failed to demonstrate a statistical difference between the two arms in patients who exhibited a 75 percent reduction in Psoriasis Area and Severity Index (PASI) score at 12 weeks.
However, the percentage of patients who manifested a 50 percent improvement in disease approached statistical significance vs. control for the highest PVAC treatment dose group (p=0.053), the company said.
And in a smaller controlled study of 60 patients in Cebu, Philippines, there was evidence of a relationship between PVAC treatment dose and response, as the percentage of patients showing 50 percent or more improvement in PASI score increased from 25 percent of placebo patients to 30 percent of those receiving 15 mcg of PVAC treatment, to just over 40 percent of patients treated with 50 mcg of PVAC treatment, the company said.
"Our reaction to this is, while we are encouraged regarding the improvements in disease that were shown in the results, I think we are hopeful that greater exposure to PVAC will result in even better effects down the road," DeNike told BioWorld Today. "So the next step as far as the program is concerned is to take a look at the results of the trial that is currently accruing in the U.S., where we've been able to make some modifications to the protocol based on what we've learned from the previous trial, and at that point, we'll do a further analysis."
The trial DeNike referenced is a Phase II blinded, controlled study that is 50 percent accrued. The study is designed to investigate four injections over 24 weeks of 15 mcg or 50 mcg treatment vs. placebo in patients with mild to moderate psoriasis.
Meanwhile, in New Zealand, the company is conducting another study of 60 patients who are being evaluated for clinical response to the combination of PVAC treatment and ultraviolet light, delivered in a controlled treatment schedule.
PVAC was developed by Corixa and Genesis, of New Zealand. DeNike would not discuss the financial arrangement between the companies, nor would he detail the terms of Corixa's marketing partnership with Medicis Pharmaceutical Group, of Phoenix, for the product.
However, according to interviews conducted on the announcement of the Corixa-Medicis deal two years ago, Corixa received a nonrefundable $17 million up-front fee, and could receive development milestone payments totaling up to $35 million, and other milestone payments of up to $55 million related to commercialization and sales. Corixa also would receive royalties. (See BioWorld Today, Aug. 17, 2000.)
Zenyaku Kogyo Co. Ltd. has the PVAC commercialization rights in the Japanese market.
Corixa on Thursday also released its third-quarter earnings. Corixa reported total revenue of $9.9 million in the quarter, compared with total revenue of $14 million for 2001's third quarter. For the first nine months of 2002, Corixa's total revenue was $39.3 million, compared with $43.2 million. As of Sept. 30, the company had about $116.6 million in cash, cash equivalents and investments.
In the conference call, Michelle Burris, Corixa's chief financial officer, said the company's guidance for the year has not changed since May. The company expects cash receipts of $70 million to $80 million, a net operating cash burn of $55 million to $65 million, revenues of about $45 million to $55 million, operating costs of $125 million to $135 million, acquisition-related expenses of $165 million, and net losses of about $45 million to $65 million, excluding acquisition-related expenses.
Also this week, Corixa and its partner, GlaxoSmithKline plc, of London, said the FDA's Oncologic Drugs Advisory Committee on Dec. 17 would hear the case for Bexxar, an investigational radioimmunotherapy for people with relapsed or refractory low-grade or transformed B-cell non-Hodgkin's lymphoma.