Replies to post #75945 on Avid Bioservices Inc (CDMO)

[asmarterwookie]

PPHMoownsme et al...Dear asmarterwookie,(lol)

Thanks for your interest in Peregrine and the upcoming AACR Annual Meeting.
The antibody used in Dr Thorpe's abstract below is a mouse version of one of Peregrine's PS-targeting antibodies.

Best Regards,
Jay

Jay Carlson | Manager, Investor Relations

Peregrine Pharmaceuticals, Inc.
14282 Franklin Avenue - Tustin, Ca - 92780
Tel: [phone] | Corporate: +1.714.508.6000 | Fax: [phone]
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Is Peregrine a part of this or is Dr. Thorpe collaborating outside of Peregrine?



Presentation Title: Cure of castration-resistant prostate cancer in TRAMP mice by reactivating tumor immunity with a phosphatidylserine-targeting antibody
Presentation Time: Tuesday, Apr 03, 2012, 1:00 PM - 5:00 PM
Location: McCormick Place West (Hall F), Poster Section 19
Poster Board Number: 12
Author Block: Yi Yin, Xianming Huang, Gustavo Barbero, Dan Ye, Philip E. Thorpe. UT Southwestern Medical Ctr., Dallas, TX

[freethemice]

Yes, the FDA has approved a drug based on a randomized, open-label, phase III trial. An example is this trial from 2010.
The Lancet, Oct 2, 2010 376:1147-54.
Prednisone plus cabazitaxel or mitoxantrone for metastatic
castration-resistant prostate cancer progressing after
docetaxel treatment: a randomised open-label trial
Johann Sebastian de Bono, Stephane Oudard, Mustafa Ozguroglu, Steinbjørn Hansen, Jean-Pascal Machiels, Ivo Kocak, Gwenaëlle Gravis,
Istvan Bodrogi, Mary J Mackenzie, Liji Shen, Martin Roessner, Sunil Gupta, A Oliver Sartor, for the TROPIC Investigators*
Summary
Background Cabazitaxel is a novel tubulin-binding taxane drug with antitumour activity in docetaxel-resistant
cancers. We aimed to compare the efficacy and safety of cabazitaxel plus prednisone with those of mitoxantrone
plus prednisone in men with metastatic castration-resistant prostate cancer with progressive disease after
docetaxel-based treatment.

[Thurly]

They can also approve based on ...

... a single-arm PII -- open label with 96 patients.

http://www.chemotherapyadvisor.com/fda-approves-erivedge-vismodegib-for-basal-cell-carcinoma-in-adults/article/225331/
FDA Approves Erivedge (vismodegib) for Basal Cell Carcinoma in Adults
Debra Hughes January 30, 2012
The U.S. Food and Drug Administration (FDA) today approved oral Erivedge (vismodegib), manufactured by Genentech, for the treatment of adult patients with locally advanced basal cell carcinoma who are not candidates for surgery or radiation and for those with metastatic disease.

Vismodegib is the first FDA-approved agent for metastatic basal call carcinoma. The FDA expedited its review of vismodegib, which inhibits the Hedgehog molecular pathway. A vismodegib capsule is taken once daily.

Efficacy and safety of vismodegib was evaluated in a pivotal international, single-arm, multicenter, two cohort, open-label phase II trial in 96 patients. The primary end point, objective response rate, was achieved in 43% of patients (27 of 63) with locally advanced disease (complete or partial response) and 30% (10 of 33) of those with metastatic disease (all partial responses). Median duration of response was 7.6 months.