* Median survival 86 weeks vs expected 24 weeks
* Full results from Phase II trial expected mid-2011
* Shares rise 18 percent
(Adds share price, analyst comment)
By Deena Beasley
LOS ANGELES, Oct 18 Interim results from a
mid-stage trial of an experimental brain cancer drug developed
by Peregrine Pharmaceuticals Inc (PPHM.O) show that patients
lived about 3 1/2 times as long as would be expected if they
were left untreated, according to the company.
The promising data sent Peregrine shares up nearly 27
Peregrine said the trial's first 14 patients lived a median
of 86 weeks, compared with expected survival of about 24 weeks
for patients whose cancer has recurred.
"It's extremely encouraging," Joseph Shan, the company's
head of clinical and regulatory affairs, told Reuters in a
Shan said a couple of patients treated in an earlier trial
of the drug, Cotara, are still alive nine years later.
The current trial is expected to enroll up to 40 patients
with glioblastoma multiforme -- the most common and deadly form
of brain cancer -- whose disease has recurred following
The initial findings are from patients enrolled at a
medical center in New Delhi, India. Full trial results,
including U.S. sites, are expected by mid-2011.
"The interim data from the lead clinical site looked very
strong for the 14 patients," said Stephen Dunn, an analyst for
"This is in patients who had their first relapse, so they
had already failed another treatment. Median survival of 86
weeks, that's pretty impressive," Dunn said.
Cotara is a genetically engineered antibody designed to
target certain cancer cells that also carries a cell-killing
radioactive isotope. It is infused directly into the tumor,
with the aim of sparing healthy tissue from the radiation.
Peregrine said it plans to meet with U.S. regulators next
year to discuss how best to move forward with development of
"Physicians know how long these patients are expected to
survive on average and that's why these data are very, very
promising," said Joseph Pantginis, an analyst for Roth Capital
Because there is a huge unmet medical need for new
treatments for this type of brain cancer, Pantginis said,
Peregrine may seek an accelerated approval that could avoid
lengthy Phase III clinical trials.
"The data are certainly positive, but they still need to
define what the potential approval path will be."
Similar "radioimmunotherapies" like Zevalin, now sold by
Spectrum Pharmaceuticals Inc (SPPI.O) for non-Hodgkin's
lymphoma, have had limited commercial success due largely to a
combination of reimbursement issues and the complexity of
coordinating patient care between oncologists and hospitals.
Steven King, Peregrine's chief executive officer, said
Zevalin, which is infused throughout the body, is associated
with bone marrow suppression -- which is not an issue with
Cotara since it is sent directly into brain tumors.
He explained that a radiation/oncology group is involved in
delivering the drug, but patients are being overseen by a
"Clearly we think there is a nice market for a drug like
Cotara," King said. "It is only used as single agent, single
infusion, but there is the potential to combine it with other
Side effects of Cotara seen in the trial included swelling
of the brain, seizures and headaches.
The study results were presented at the Congress of
Neurological Surgeons Annual Meeting in San Francisco.
Peregrine shares were up 30 cents, or 18.3 percent, at
$1.94 on Nasdaq after climbing as high as $2.08 earlier in the