Replies to post #108950 on Avid Bioservices Inc (CDMO)

[freethemice]

Slight error in your numbers

Months post start of trial: 31 (at data release, Sept 2012)

PR states trial enrollment opened June 4, 2010, enrollment ended Oct 6, 2011.
At data release Sept 7, 2012 there were 27 months elapsed, not 31.

Then 13/27 = 0.48. Applying this to the pancreatic trial gives
24 months * 0.48 = 11.5 months. BINGO!

[freethemice]

I think it comes down to how the enrollment proceeded in both trials.
The second-line NSCLC trial took 16 months (June 4, 2010 - Oct 6, 2011) to enroll 121 patients.
The pancreatic trial took 17.5 months (Jan 5, 2011 - June 25, 2012) to enroll 70 patients.
At the time the data was reported for the second-line NSCLC trial the MOS of 13 months was only
2 months more than the time since enrollment closed. If the pancreatic trial took about 3 months to enroll
the last 10% of the patients I can see how the MOS could be much longer than the time since the enrollment closed.

[sunstar]

In trying to estimate the moving date point for MOS in the pancreatic trial, I would consider the following: For any trial, the ability to steadily enroll patients is important. If I remember correctly, Peregrine had some delays in finding patients to enroll at the rate they had anticipated. I believe they may have added extra clinics, mid term, to finish the enrollments on schedule. The mid-point of enrollment may be located later into the trial than what might be an average mid-point.

I would be looking for an estimated date for half enrollment slightly later, and use a more conservative moving average MOS date as time elapses without any announcements of reaching an MOS in the pancreatic trial,

From the Clinical Trial site:

“Primary Outcome Measures:

Overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab. [ Time Frame: One year ]

[ Designated as safety issue: No ]

To compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.”

We will be looking for a percentage of patients alive after one year.

Abraxane + Gem had 35% alive after one year.

Pancreatic cancer is difficult. Let’s hope that bavi can offer something more to patients with its immunotherapeutic qualities fighting the primary tumor, and going after metastases.

IMO

sunstar