Partnering hopes may have dimmed for Poniard Pharmaceuticals Inc. with the unveiling of Phase II results with picoplatin in metastatic colorectal cancer, news that follows the failure of the chemotherapy agent late last year in a Phase III trial against small-cell lung cancer.

But you wouldn't know it from talking with Jerry McMahon, chairman and CEO of South San Francisco-based Poniard.

"Our goal with this trial was to unequivocally show that we don't have the neuropathies associated with the current standard of care," he said.

"It was powered and designed for that. We can say with clarity we achieved that goal. Obviously, that's not where everybody's focused today," McMahon added.

Sure enough, Poniard on Sunday said final data from the Phase II trial met its primary objective, showing that picoplatin in combination with 5-fluorouracil and leucovorin (the FOLPI regimen) dropped neurotoxicity to a statistically significant degree (p < 0.004) compared to oxaliplatin given as a combo with 5-fluorouracil and leucovorin (FOLFOX), and suggested similar efficacy between the two.

The company's shares (NASDAQ:PARD) fell 25.3 percent on the CRC disclosure, ending Monday at $1.95, down 66 cents.

That's still above the level - $1.83 - to which the stock descended during its 76 percent plunge after the November 2009 results in SCLC were made public. Poniard enjoyed a bit of a run-up last Friday as investors awaited the latest results. (See BioWorld Today, Nov. 17, 2009.)

Although overall survival metrics didn't show a difference between the two arms, "our view of the survival curves indicates that patients treated with picoplatin trended worse" than those who got oxaliplatin, wrote Canaccord Adams analyst George Farmer in a research note. Poniard's chance for a partnership "looks dim," in Farmer's view.

"Analysts are not drug developers," McMahon said. "You need a bigger trial, and probably a more optimized protocol [to show convincing efficacy]. These are things that are not unfamiliar to partners."

The Phase II data were detailed in Orlando, Fla., at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancers Symposium. In progression-free survival, the median was 6.8 months in FOLPI patients and 7.0 months in FOLFOX (p = 0.82, hazard ratio 0.95). In overall survival, the median was 13.6 months in FOLPI, 15.6 months in (p = 0.53, HR 1.17).

At one year, the OS rate was 80 percent vs. 83 percent. Six-month and one-year survival reached 80 percent and 52 percent in FOLPI-treated patients, respectively, as compared with 83 percent and 55 percent in FOLFOX.

The data seem equal at the median and one-year overall survival points, but the curves separate at others, always in favor of FOLFOX, Farmer wrote. "No statistical analysis was provided at these [other] time points, but in our view, the negative trend observed does not support the non-inferiority of FOLPI vs. FOLFOX," based on overall survival, in his view.

Oppenheimer analyst Bret Holley agreed, saying in a report that neurotoxicity is important to some patients, but not enough that doctors would sacrifice efficacy - if efficacy with picoplatin must be sacrificed at all, an idea that has yet to be proven, McMahon was quick to remind.

The outcome of the Phase II trial and 170 patients worth of data in CRC "key up the indication for a partner very nicely," especially with oral product behind the intravenous version, he said.

Howard Liang, with Leerink Swann, was nervous about the prospects for Phase III trials in CRC.

Poniard, however, believes the results will support the design of a Phase III effort, and plans an end-of-Phase II meeting with the FDA.

"Obviously, people who are focused on median and not so much the confidence interval are drawing the conclusion that the picoplatin-containing regimen is inferior," an opinion that McMahon called "completely inappropriate, given the amount and accuracy of the data we presented."

Anyway, the "mixed reviews" by analysts is focused on efficacy, while the trial was designed to show benefit in neuropathy, he said.

"I don't want to diminish the potential to be useful in CRC; I think our data support that," McMahon said, but the compound is being developed in other tumor types as well - SCLC plus ovarian and prostate.

Results from a Phase II trial in prostate cancer are expected in March, and the Phase III data, due for dissection at the American Society of Clinical Oncology meeting in June, are still being sifted during talks with the FDA.