Replies to post #54726 on Avid Bioservices Inc (CDMO)

[MobyInvestor]

How is it possible that the primary and secondary outcome measures both indicate "Designated as safety issue: No" when the endpoint classification is "safety study"?

Pharmacokinetics covers a lot of ground. Yes, it's a phase I evaluation criteria but, it's not necessarily a safety issue.

However, how did you miss the first 3 measures in the primary outcome that were safety issues?

# adverse events [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
# laboratory evaluations [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
# human anti-chimeric antibody [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Regards,

moby

[Thurly]

Apologies, I copied the wrong clinical trial. My bad.

http://clinicaltrials.gov/ct2/show/NCT00687817?term=bavituximab&rank=3

Study Type: Interventional
Study Design: Control: Uncontrolled
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Paclitaxel Carboplatin Bavituximab
U.S. FDA Resources

Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Time to tumor progression, duration of response, overall survival and safety [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Also

http://clinicaltrials.gov/ct2/show/NCT00669565?term=bavituximab&rank=6

Official Title: A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Paclitaxel Carboplatin Bavituximab
U.S. FDA Resources

Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
The primary objective of this study is to determine the overall response rate (CR+PR) [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Finally

http://clinicaltrials.gov/ct2/show/NCT01138163?term=bavituximab&rank=9

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel Bavituximab
U.S. FDA Resources

Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
Objective Response Rate [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

[cjgaddy]

Thurly, this Ph.2/3 doesn’t eval. for safety line is just the latest in a series of difficult to comprehend statements/positions from our friend Moby, like: Proxy saying 15mm Incentive-Plan shares will be split adjusted means they won’t be, Garnick is here only to start trials with 2nd gen. mabs not Bavi, 80% of Peregrine/Avid’s 135 emps are part-timers, let’s look at Jan-July’09 OS (not Apr-July) to gage the “the spike during 2009 ASCO”, and now: they test for safety in Phase I, not II or III.

I tried and tried to get to the bottom of those statements - to no avail.

I appreciate all your many contributions here, BTW.