PROGEN PI-88 ‘DOUBLES’ TIME TO LIVER CANCER RECURRENCE
November 12th 2007 09:22
Biotech Daily
Monday November 5, 2007
Daily news on ASX-listed biotechnology companies
Monday November 5, 2007
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS DOWN: PHYLOGICA UP 7%, CYTOPIA DOWN 8%
* PROGEN PI-88 ‘DOUBLES’ TIME TO LIVER CANCER RECURRENCE
* CATHRX ACQUIRES 2 CARDIAC CATHETER-RELATED PATENTS
* CHINA, SOUTH KOREA GRANT PATENTS TO IMUGENE
* ORBIS TAKES 19.4% OF ACRUX
* AVANT MERGER ENDS SELECT VACCINES LICENCE
* KARMELSONIX REQUESTS TRADING HALT
THE MARKET
Nine of the Biotech Daily Top 40 stocks were up, 20 stocks fell, nine traded unchanged and two were untraded.
Phylogica was best, up 1.5 cents or 6.82 percent to 23.5 cents with 72,000 shares traded, followed by Acrux up 4.15 percent to $1.38 and Ventracor up 4.2 percent to 74.5 cents, with 2.2 million shares traded.
Cytopia led the falls, down four cents or 8.16 percent to 45 cents with 122,300 shares traded, followed by Antisense down 0.3 cents or 6.25 percent to 4.5 cents on moderate volumes.
subscribe to Biotech Daily at the link above
PROGEN
Progen says PI-88 has doubled the time to recurrence for high risk of recurrence post-operative liver cancer patients.
Progen released the further data from its completed phase II liver cancer trial at the 58th annual meeting of the American Association for the Study of Liver Diseases in Boston.
Progen said the trial’s study period covered 48 weeks from curative surgery.
The company said the data analysis from the phase II trial, described in the presentation was performed to evaluate the treatment’s impact, when patients with a low risk of experiencing a liver cancer recurrence within twelve months, were removed from the analysis population.
Patients were removed from the patient population if, based on published prognostic factors, they were considered likely to complete the 12 months of the study without recurrence.
The resultant analysis of those patients who had a high risk of recurrence in the 12-month period showed that “PI-88 at least doubled the time to disease recurrence calculated at the 60th percentile (p=0.0107) (control (n=33): 24 weeks versus 160mg PI-88 (n=36): 48 weeks)”.
“This compares to a 76 percent improvement at the 70th percentile (p=0.0867) if all patients are included, as reported earlier this year,” Progen said.
Progen’s vice president of clinical and medical affairs Dr James Garner said that about 50 percent of untreated patients were “likely to experience disease recurrence within 12-15 months after they have had curative liver cancer resection”.
“Given our phase II study only assessed the recurrence of disease up to 12 months after surgery this implies that approximately half of the study population were unable to provide information about the efficacy of the drug,” Dr Garner said.
“When you remove from the analysis patients unlikely to recur in the study time frame, the treatment effect of PI-88 as measured in the phase II study is more clearly demonstrated,” Dr Garner said.
“These data further expand our confidence that our 600-patient phase III study will demonstrate PI-88’s effect not only for those patients likely to recur within a relatively short period of time but also for those whose chance of recurrence is delayed, as the phase III study is designed to treat and follow patients for a longer period of time,” he said.
The double-blind placebo controlled phase III study is designed to assess, as its primary endpoint, improvement in disease free survival, among 600 patients in North America, Europe and Asia, following surgery to remove liver cancer tumors.
Progen said half of the patients in the study will be administered PI-88 after surgical removal of tumors and the remaining patients will receive a placebo so that a direct statistical comparison between the placebo and PI-88 can be made.
A copy of the poster presentation is at www.progen-pharma.com.
Progen climbed three cents or 1.05 percent to $2.90.
Subscribe to Biotech Daily at the link above
| 25 |
| Vote |
Add To: 
subscribe to this blog