annual meeting

The following is from sir_wallow on the nrt site at yahoo finance at
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=22689364&tid=nvgn&sid=22689364&mid=7361

He attended the NRT annual meeting

G

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A quick report of the important points from the AGM today.

1. Phase II ovarian results. There appeared to be a discrepancy between the May announcement of 33% objective response rate and Tuesdays update. It turns out that the trial was modified to consist of three one-month segments; patients who were treated in Melbourne were all local ladies who returned after their therapy to have confirmatory CAT scans in accordance with RECIST criteria, but the Yale patients came from far and wide and twelve who experienced either a Partial Response or Stable Disease simply went home after their treatment and did not return for a follow-up scan. In the May PR they were classified as responders but this week they were classed under RECIST criteria as progressive, even though there was no reason to expect that their tumors had regrown.

2. Detailed results.

................PXD+Cis....PXD+Pac
Total............19.........17
CR...............2(11%).....1(6%)
PR...............4(21%).....4(24%)
SD...............9(47%).....9(53%)
Prog.............4(21%).....3(18%)

ORR 11/36 or 30%. The absence of the twelfth responder from the original figures was explained but I missed the detail.

All patients who were double checked after at least one month retained their response, but 12 did not turn up for their scans.

................PXD+Cis........PXD+Pac
Total............19...............17
CR...............2................1
PR...............2(2 missing)...1(3 missing)
SD...............4(5 missing)...7(2 missing)
Prog............11(7 added).....8(5 added)

ORR 6/36 = 16.6% but not a true picture

Novogen did not need confirmatory scans to know that combination therapy worked (at the Phase II level) but Yale put the results in RECIST form in the second announcement, even though some responders did not turn up for their second scan, hence the confusion.

3. OVATURE trial. The trial will not start until early 2006 because of changed FDA rules (now require a single trial to cover both Accelerated and Full approval) and the FDA approval of Doxil for third line therapy. Novogen had to completely rewrite the protocol and there were further delays when Hurricane Katrina caused disruption to the FDA.

4. OVATURE details. The trial will be conducted in up to 50 sites world-wide and will have 400 patients. Oral PXD will be used.

5. ORAL PXD. The trial protocol for the current Phase II trial was amended to add 20 to 30 patients who have been treated exactly as will OVATURE patients. The results must have been OK: Oral PXD will be used in OVATURE.

6. NV143 - Melanoma. 10 to 20 times more powerful than PXD.