PROGEN INDUSTRIES (PGLA)
Good News For Liver Cancer Patients
On December 18, in the Prohost E-Letter issue # 250, we recommended buying Progen (PGLA), stating that: “ The news from this firm, we believe, is promising for three reasons. The first is that the firm’s drug, PI-88 is an antiangiogenesis drug, meaning that it halts the growth of new blood vessels in cancers. It is of the same category as Avastin, Genentech’s breakthrough blockbuster. The second reason is that the drug also kills metastatic cells, i.e., cancer cells that spread to other organs. And, thirdly, which might be more important than all other reasons, is that the drug has shown efficacy on a very nasty cancer, hepatoma, which is a deadly liver cancer that afflicts patients infected with hepatic B or C viruses. The disease kills patients in less than a year. We believe that PGLA is worth much more than its current price even after the stock surge. The stock price hit over $6 following the good news. Now, it trades at $4.80, following the selling by those who doubled their investment in the firm. We do not blame them. Yet, we will blame ourselves if we overlook the value of this firm. We buy and accumulate on any further dips.”
That’s what Prohost wrote in the e-Letter issue on December 18, 2006.
Today, PGLA doubled. Why?
For the same reason we mentioned in our E-Letter issue 4 months ago. Progen Pharmaceuticals (PGLA) announced the final stage 1 results of its Phase 2 trial of PI-88 in patients who had previously undergone surgical removal of liver cancer. The 48 week data demonstrated that 160 mg of PI-88 caused an improvement in disease-free rate, the primary endpoint, and prolonged the time to tumor recurrence (disease- free survival) from 27 to 48 weeks, or by 78 percent, building on the 30-week results announced in December 2006.
The first stage of the randomised, two-stage multi-centre Phase 2 trial was designed to determine the appropriate dosage and possible efficacy of PI- 88 in reducing tumor recurrence in liver cancer patients who had previously undergone surgical removal of the cancer. Patients in this stage of the Phase 2 trial were randomly assigned to one of three groups to receive either the standard of care (with no PI-88 treatment), 160 mg of PI-88, or 250 mg of PI- 88, over 36 weeks with a 12 week follow-up period.
Summary of results
Treatment with 160 mg of PI-88 increased the disease-free rate by approximately 25 percent, from 50 percent to 63 percent at 48 weeks.
Treatment with 160 mg of PI-88 increased the time to recurrence of disease (disease-free survival) by approximately 78 percent, from 27 to 48 weeks.The final results confirmed the trend identified in the 30-week assessment that PI-88 delayed the recurrence of disease and increased the likelihood that the patient would be disease free for a longer period. The 160 mg dosing level of PI-88 revealed a strong safety and tolerability profile and few adverse events directly or possibly related to treatmentAs the 160mg dose was well tolerated and showed positive results in this study, Progen has decided to pursue the 160 mg dose of PI-88 in the Phase 3 development.
Treatment with the higher dose (250 mg) resulted in thirteen patients discontinuing treatment early partly due to adverse events, possibly related to treatment at this dose level. This impacted the results seen from this treatment arm. The 250 mg dose of PI-88 reduced the disease-free rate by approximately 19 percent as compared to the control group, from 50 percent to 41 percent at 48 weeks, and was inseparable from the control group as to disease-free survival.
“These Phase 2 data clearly support the conclusion that PI-88 has the potential to extend the disease-free survival time of patients with post- resection liver cancer, who have few if any treatment options and a high likelihood of disease recurrence,” said Professor Peier Chen, Director of the Medical Research Department of the National Taiwan University Hospital, and the trial’s principal investigator. “We have waited a long time to see progress in this area of research and these data represent an important step in the development of treatments for post-resection liver cancer. PI-88 certainly warrants accelerated clinical investigation to enable us to develop a potential new treatment for liver cancer patients as quickly as possible.”
“We are excited with the strong results PI-88 demonstrated in slowing the return of liver cancer,” said Justus Homburg, Chief Executive Officer of Progen Pharmaceuticals. “These data give us the confidence to aggressively pursue the development of PI-88 towards registration and commercialisation.”
“On the basis of these data and our discussions with FDA, we are no longer contemplating conducting stage 2 of this Phase 2 trial. We are now planning a multinational Phase 3 trial of PI-88 at a dose of 160 mg/day, to begin patient enrolment in the second half of 2007. The Phase 3 trial will be designed with overall survival and disease-free survival endpoints.”
This is good news.
Prohost congratulates its subscribers who bought the stock.
