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FDA Fast Tracks Antigenics' Oncophage For Kidney Cancer.(Brief Article)
2001 NOV 7 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration has designated Oncophage, a cancer vaccine candidate developed by Antigenics, Inc. (AGEN), a Fast Track Product for the treatment of renal cell carcinoma.
In the FDA's letter to Antigenics, the agency stated that it is "designating as a Fast Track development program the investigation of Autologous Tumor-Derived gp96 Heat Shock Protein-Peptide Complex (HSPPC-96, Antigenics) for its superior effect on survival as an adjunct to surgical resection of renal cell carcinoma compared with no additional postsurgical treatment."
Oncophage is a vaccine comprised of a specific class of proteins known as heat shock proteins. Heat shock proteins are isolated from each patient's cancer and contain a unique profile of signals, which are the cancer's "DNA fingerprint." These unique signals have the capacity to reprogram the immune ...
- Antigenics' Oncophage(R) Becomes First Personalized Cancer Product To Receive...
- Press release article from: PR Newswire October 15, 2001 700+ words
...application for approval. Fast Track designation is granted...is "designating as a Fast Track development program the...Tumor-Derived gp96 Heat Shock Protein-Peptide Complex...cancer vaccine to receive Fast Track designation. Antigenics...
- Antigenics' Heat Shock Protein Technology Platform Expanded With 15 Key Patents.
- Press release article from: Business Wire July 31, 2002 700+ words
...expansion of protection of its heat shock protein (HSP) technology platform...Antigenics remains the leader in heat shock protein technology," said Russell...in Phase III trials and granted Fast Track designation by the U.S. Food...
- Nine New Patents Expand Antigenics' Leadership Position in Heat Shock Protein...
- Press release article from: Business Wire December 19, 2002 700+ words
...announced today the expansion of its heat shock protein (HSP) technology platform...As leaders in the field of heat shock protein immunotherapy, we continue...in Phase III trials and granted fast track and orphan drug designations by...
- Stressgen Receives FDA Fast Track Designation for HspE7; -- Lead Product...
- Press release article from: PR Newswire December 4, 2003 700+ words
...Stressgen. With the Fast Track Development program...approval. Sponsors of Fast Track Development program products...designated HspE7 for a Fast Track Development program after...immunostimulatory powers of heat shock proteins utilizing recombinant...
- Synta Pharmaceuticals Announces FDA Fast Track Designation for STA-4783 in...
- Press release article from: Business Wire November 15, 2006 700+ words
...unmet medical needs. Fast Track designation allows a...the review process. Fast Track designation may facilitate...review period. However, Fast Track designation has no impact...production of Hsp70 and other heat shock and stress-related...
- Heat Shock Proteins and Cardiovascular Pathophysiology.
- Magazine article from: Physiological Reviews SNOECKX, LUC H. E. H. CORNELUSSEN, RICHARD N. VAN NIEUWENHOVEN, FRANS A. RENEMAN, ROBERT S. VAN DER VUSSE, GER J. October 1, 2001 700+ words
...These proteins were originally called "heat shock proteins" [356], because they were...from a so-called transient sublethal heat shock, during which body temperature was increased...core temperature (400). Such a mild heat shock elicited a heat shock response, ...
- Regulation of the heat-shock response in bacteria.
- Magazine article from: Annual Review of Microbiology Yura, T. Nagai, H. Mori, H. January 1, 1993 700+ words
KEY WORDS: heat-shock protein, stress response, [sigma...INTRODUCTION 322 INDUCTION OF HSPS AND THE HEAT-SHOCK REGULON 323 ROLE OF [[sigma].sup.32] IN TRANSCRIPTION OF HEAT-SHOCK GENES 324 ROLE OF [[sigma].sup...
- Mojave Therapeutics Announces Publication on the Identification Of an Important...
- Press release article from: PR Newswire September 30, 2002 700+ words
...emerging leader in the development of heat shock protein-based immunotherapies, announced...cell surface receptor molecule for human heat shock proteins. This research was conducted...cells in the body interact with human heat shock proteins was published today in The Journal...
- A raison d'etre for heat-shock proteins.
- Magazine article from: Science News Vaughan, Christopher May 7, 1988 700+ words
A raison d'etre for heat-shock proteins Cells of all organisms respond to heat or other stresses by making complex molecules called heat-shock proteins. Ohter heat-shock proteins exist in unstressed cells and seem to play...
- Heat shock treatment lessens E2F1-DNA binding, E2F1 levels in human A549 cells.
- Newspaper article from: Cancer Weekly March 25, 2003 700+ words
...cells are arrested at these checkpoints after heat shock it was of interest to test heat shock effects on E2F1 activity," stated biochemists...of Bremen, Germany. In human A549 cells, heat shock (44 degrees C, 30 minutes) caused an immediate...
Source: HighBeam Research, FDA Fast Tracks Antigenics' Oncophage For Kidney Cancer.(Brief...