TUSTIN, Calif., March 11 PeregrinePharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceuticalcompany developing monoclonal antibodies for the treatment of cancer andhepatitis C virus infection, today released an update from two clinical trialsassessing its targeted therapy Cotara(R) in the treatment of glioblastomamultiforme (GBM), the most deadly form of brain cancer. The Cotara clinicalupdate covers the first cohort of patients in its dosimetry trial as well asexperience to date in an ongoing Phase II safety and efficacy trial. Inpatients treated in the studies, Cotara appears to be safe and well tolerated,with no dose-limiting adverse events. Patients who are continuing in thetrials are being monitored for safety and overall survival, with severalsurpassing the median expected survival time for relapsed GBM patients. Therecent addition of new clinical sites in both the dosimetry and Phase IItrials is expected to help accelerate the pace of patient enrollment goingforward. The company also announced that data from the first patient cohortin the dosimetry trial has been accepted for presentation at the 2008 ASCOAnnual Meeting.
"We are encouraged by early results from these two Cotara clinical studiesand look forward to presenting data from the dosimetry trial at the upcomingASCO Annual Meeting," said Steven W. King, president and CEO of Peregrine."In view of the short expected survival time of approximately six months inthis patient population, it is promising that we have early GBM patients inthese trials who have survived past the six-month timeframe, with one patientnow surviving 15 months post-treatment."
The open-label Phase I dosing and dosimetry study at U.S. brain cancercenters is enrolling GBM patients with recurrent disease. Patients in thistrial receive an initial imaging dose of Cotara before receiving thetherapeutic dose. The study's main objectives are to confirm the maximumtolerated dose, to determine radiation dosimetry and to assess overall patientsurvival, progression-free survival and the proportion of patients alive atsix months following Cotara administration. In the three GBM patientsenrolled in the first cohort, Cotara was safe and well tolerated, with nodose-limiting toxicities. Patients have been followed post-treatment todetermine overall survival, with the first treated patient currently surviving15 months post-treatment and the last treated patient currently surviving fourmonths post-treatment. Dosimetry analysis indicates that Cotara wasconcentrated only in the tumor in these patients, and not in other organs.
Mr. King added, "With enrollment of the second patient cohort underway, wewelcome Dr. William Shapiro of the Barrow Neurological Institute as principalinvestigator of our newest dosimetry study clinical site. Dr. Shapirosuccessfully participated in earlier Cotara studies and we are delighted thathis center is now participating in the Cotara dosimetry trial."
"We are pleased to join the dosing and dosimetry trial of Cotara for thetreatment of recurrent GBM," said Dr. William Shapiro, director, neurooncology program; Marley chair, neurology; professor of neurology, Universityof Arizona College of Medicine; and Cotara principal investigator at theBarrow Neurological Institute. "GBM is a deadly disease with very poorsurvival prospects for relapsed patients, and improved therapies are urgentlyneeded. We are hopeful that the encouraging survival trends seen in previousCotara studies will be replicated in larger trials going forward, and we viewthis dosimetry trial as an important step on that path."
Mr. King continued, "We are also pleased to report that we have recentlyadded additional clinical sites to the Cotara Phase II study, increasing thetotal participating centers from three sites to eight sites. We anticipateenhanced enrollment rates going forward, particularly in