CHICAGO and TUSTIN, Calif., May 31 PeregrinePharmaceuticals, Inc. (Nasdaq: PPHM) today reported that clinical researchersfrom the Abramson Cancer Center of the University of Pennsylvania will presentdata showing that its brain cancer agent Cotara(R) specifically localizes tobrain tumors at high concentrations with minimal radiation exposure to otherorgans. Cotara is a targeted monoclonal antibody linked to a radioisotopebeing developed as a potential new treatment for glioblastoma multiforme(GBM), a deadly form of brain cancer. Cotara specifically targets cells atthe center of brain tumors, so its radioactive payload is able to kill cancercells while leaving healthy tissue largely unaffected. The study results showthat the concentration of Cotara in brain tumors was at least 100-fold higherthan in other organs, and all of the GBM patients in the study cohortdiscussed in this presentation have surpassed the expected median six-monthsurvival time for this patient population.
No dose-limiting toxicities were reported in this dosimetry study,confirming other clinical data showing that Cotara appears to have a goodsafety profile. The Cotara data will be presented on Sunday at the 44thAmerican Society of Clinical Oncology (ASCO) Annual Meeting in Chicago,Illinois.
"These findings confirming Cotara's potential to target its radioactivepayload to brain tumors while minimizing radiation exposure to healthy organshave enabled us to advance this Cotara trial to the next stage," said Dr.Kevin Judy, associate professor neurosurgery at the University of PennsylvaniaSchool of Medicine and a principal investigator of the Cotara dosimetry trial."Cotara's good safety profile to date is especially encouraging in view of thetoxicity of the treatment options currently available to GBM patients. Welook forward to further assessing its safety and anti-tumor activity at thehigher doses we plan to use in the next stages of the trial."
The open label dose confirmation 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.
"These positive data validate a key principle underlying the Cotaraprogram, confirming its ability to specifically concentrate in and deliver ahigh radiation dose to brain tumors," said Steven W. King, president and CEOof Peregrine. "These results also further confirm the key targeting attributeof Cotara, showing it results in minimal radiation exposure to other organs,including the thyroid. We also are encouraged that patients in this initial,low-dose cohort have already lived longer than the expected median survivaltime for GBM patients at first relapse, and we look forward to reportingfurther data on Cotara in the coming months."
The dosimetry study's main objectives are to confirm the maximum tolerateddose of Cotara, to determine radiation dosimetry and to assess overall patientsurvival, progression-free survival and the proportion of patients alive atsix months following Cotara administration. In addition to the University ofPennsylvania Medical Center, the Medical University of South Carolina inCharleston and the Barrow Neurological Institute in Phoenix, Arizona areparticipating in the trial. A fourth study site was recently initiated atCase Western Reserve University in Cleveland, Ohio. Peregrine is alsoconducting a Cotara Phase II safety and efficacy trial in India in GBMpatients at first relapse. In patients treated to date, Cotara appears to besafe and well tolerated.
Cotara is an experimental treatment for brain cancer that links aradioactive isotope to a targeted monoclonal antibody. This monoclonalantibody is designed to bind to a type of DNA that is exposed only on dead anddying cells, and solid tumors have many dead and dying cells