Interim analysis of Phase 2 clinical data presented at the 2007 Chemotherapy Foundation Symposium

BOULDER, Colo., Nov. 9 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) today released interim findings from its Phase 2 trial of Amrubicin in second-line chemo-sensitive small cell lung cancer (SCLC). Amrubicin, the company's third-generation synthetic anthracycline, is a potent topoisomerase II inhibitor currently in development for the treatment of SCLC. These findings indicate favorable interim results in terms of response rate and survival for Amrubicin in second-line treatment of small-cell lung cancer patients with extensive disease (ED) SCLC. The early results of this study were presented at the 2007 Chemotherapy Foundation Symposium today in New York City.

'Treatment options for second-line SCLC are limited and preliminary data from the US-based Phase 2 sensitive SCLC trial indicate that Amrubicin may provide a new option for SCLC patients who desperately need more treatment choices,' said principal investigator Robert M. Jotte, MD, PhD, Medical Director of the Lung Cancer Clinic of the Rockies, Developmental Co-Chair USON Lung Committee. 'As we near completion of the Phase 2 trial, we hope that accrual to the Phase 3 trial will be rapid and confirm the results of the US Phase 2 trial and similar trials in Japan.'

The trial presented today compares Amrubicin and topotecan in patients with ED-SCLC that initially responded to first-line platinum-based therapy but whose disease recurred or progressed at least 90 days after completion of first-line treatment (sensitive SCLC). Study participants are randomized in a 2:1 ratio to receive either IV Amrubicin (40mg/m2 daily for 3 days) or topotecan (1.5 mg/m2 daily for 5 days), both starting on Day 1 of a 21-day cycle.

Response data from 42 patients have been analyzed, 28 treated with Amrubicin and 14 with topotecan. Eleven of 28 (39 percent) patients who received one or more cycles of Amrubicin have demonstrated a response, including two complete responses (CR) and nine partial responses (PR). Eight of the responses are confirmed and three are pending follow-up scans. Two of 14 (14 percent) patients who received one or more cycles of topotecan had a response (both PRs). One is confirmed and one is pending a follow-up scan.

Survival times are not yet mature, however, at this time preliminary data already show an observed difference of 2.4 months in overall survival, which translates to a hazard ratio of 0.67, favoring Amrubicin.

The most common adverse events were hematological and were generally equal between the two arms.