Avid Bioservices Inc (CDMO)

[cjgaddy]

Oct22: Stanford's Dr. Susan Knox (Cotara) at Princeton

OCT 21-23 2004: “10th Conference on Cancer Therapy with Antibodies & Immunoconjugates”, Princeton NJ
http://www.imedex.com/announcements/goldenberg04.html
“This conference has succeeded in bringing together investigators from cancer immunology, cell biology, molecular biology, radiation physics, nuclear medicine, pharmacology, and clinical oncology to report their latest findings on the use of naked or conjugated (isotopes, drugs or toxins) antibodies, including pretargeting methods, for the therapy of hematological and solid tumors. . . . Clinical results of new antibodies and antibody conjugates being pursued by biotechnology and pharamaceutical companies also will be emphasized. . . .As in the past, the proceedings of the conference will be published in a major, peer-reviewed cancer journal, such as Clinical Cancer Research.”

Scientific Committee includes: Susan J. Knox, MD, Stanford University

Oct 22 11:00: Session V: Clinical Radioimmunotherapy – Hematopoietic Tumors
Moderators: Gerald L. DeNardo and Susan J. Knox

Oct 22 4:00: Susan J. Knox, Stanford University
“Phase I Study of 131I-Chimeric(ch) TNT-1/B Antibody for the Treatment of Advanced Colorectal Cancer”
(part of Session VI: Clinical Radioimmunotherapy – Solid Tumors)

Oct 23 10:15: Panel Discussion: Future of Radioimmunotherapy
Leader: Gerald L. DeNardo
Panelists: Jean-Francois M. Chatal, Ludger Dinkelborg, Susan J. Knox,
Steven M. Larson, Andrew Scott and George Sgouros

####Note: Dr. Susan J. Knox is the Study Coordinator for Peregrine’s “Cotara Phase I Clinical Trial for the Treatment of Colorectal Cancer” at Stanford Univ. PPHM’s 8-2-04 PR announced that patient enrollment has been completed in this Phase I trial.

####Also note that Dr. Gerald DeNardo of USC-Davis, the author of 250+ articles, was Techniclone’s PI for Lym-1/Oncolym Studies, a close associate of Dr. Epstein, and published most of the data on the clinical use of Oncolym in NHL, before ScheringAG took over in 2000. GENESIS_TCLN, help me with the history here!

=============
What we know about Stanford’s Phase1 Cotara Trials for Colorectal:

Recap of SK’s 9-28-04 WallStReporter Interview:
“Hoping to early next year begin Cotara Phase 2 for other solid tumor types”

Summary of King’s UBS talk 9-29-04:
“TNT/Cotara: Have data on brain, lung, colon, pancreatic, liver, prostate
Have completed enrollment for Stanford Ph1 colorectal study – analyzing it to plan ph2 studies to broaden applications of Cotara
Cotara: Orphan US & EUR, Fast Track in U.S. - plans:
a) Expand indications beyond brain: possibly lung, hepatic
b) Use Cotara with other therapies, like radiation b4 Cotara (gives more target)
PPHM Goal: Compl. data analysis of Cotara [Stanford] ph1 & plan future clinical studies”

PR 8-2-2004: Stanford Phase I Cotara/Colorectal Completion
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=599544
"Peregrine Pharmaceuticals Announces Patient Enrollment Completion for Cotara(TM) Phase I Study for Colorectal Cancer"
TUSTIN, CA, Aug. 2 2004: Peregrine Pharmaceuticals (Nasdaq: PPHM) announced today that patient enrollment has been completed in its colorectal cancer Phase I clinical trial evaluating Cotara(TM) at Stanford University. The Phase I study was designed to determine the maximum tolerated dose (MTD) and safety profile of intravenously administered Cotara. Cotara is an Iodine-131 radiolabeled Tumor Necrosis Therapy (TNT) monoclonal antibody that may be useful for the treatment and diagnosis of various solid tumor cancers. Interim data from the trial is currently being analyzed as follow-up data on treated patients continues to be collected.
"We have achieved an important milestone in the development of Cotara for treating solid tumors," said Steven King, Peregrine's president and chief executive officer. "The safety and distribution data generated from this study will be used to guide us in the planning of Phase II clinical studies in other solid tumor indications. We will be working closely with our scientific advisors and investigators to explore all development options for Cotara, both as a single agent and in combination with other therapies."
About Tumor Necrosis Therapy (TNT):
Rapidly growing tumors quickly outgrow their blood supply resulting in a region of tumor cells that do not receive adequate oxygen, nutrients and waste removal. The accumulation of dying cells results in the formation of a dead, or necrotic, core present in virtually all solid tumors beyond a very small size. Tumor Necrosis Therapy (TNT)-based products directly target and bind to dead and dying tumor cells found in virtually all solid tumors. Hence, TNT- based therapeutic agents have the potential to deliver therapeutic agents preferentially targeted to virtually all solid tumors. Peregrine's TNT antibodies bind to universal intracellular antigens, DNA/Histone complexes, exposed in the necrotic core of malignant solid tumors. Since DNA and Histone are not normally accessible in normal tissues, the DNA/Histone complex represents a stable and specific marker of tumors Given TNT's near universal appearance as a tumor marker, TNT antibodies make excellent delivery molecules for a wide variety of anti-cancer killing agents. To date, the TNT technology platform has been used to deliver various killing agents such as radioactive isotopes and cytokines to solid tumors.
*snip*