Media
Corgentech Receives FDA Fast Track Status for Drug to Prevent "AV Graft" Failure in End-Stage Renal Disease Patients
-- Company Plans to Start Phase I/II Trial Shortly --
Palo Alto, Calif., January 23, 2003 -- Corgentech Inc., a privately-held biotechnology company, announced today that the United States Food and Drug Administration (FDA) has granted fast track designation for the company's second product, CGT021, which soon will enter a Phase I/II clinical trial for the prevention of arterio-venous (AV) graft failure in End-Stage Renal Disease (ESRD) patients requiring hemodialysis.
AV grafts provide access for blood to be filtered by a dialysis machine, allowing these patients to receive life-saving hemodialysis treatments. Currently, more than half of these connections fail at six months and about 95 percent fail at two years, requiring costly hospitalizations and salvage procedures. There currently is no approved treatment to preserve AV graft function.
The FDA stated, in part, in its letter to Corgentech that it is granting fast track designation for CGT021 because of the company's commitment to study its effects "on endpoints with clear clinical relevance" and the proposal "to investigate a patient population that has a serious or life-threatening condition," and because "the failure of hemodialysis conduits is an unmet medical need."
Shortly, the company expects to begin a multi-center, double-blind, randomized, placebo-controlled Phase I/II clinical trial with CGT021 in patients with chronic renal failure, or ESRD, requiring hemodialysis. Corgentech's first product CGT003, currently in Phase III clinical trials for the prevention of vein graft failure following coronary artery and peripheral (i.e., leg) arterial bypass procedures, also received FDA fast track designation.
"We are gratified that the FDA has granted us fast track review status for our second product in this serious and life-threatening condition," said John P. McLaughlin, Corgentech's president and chief executive officer. "Nearly every dialysis patient faces AV graft failure, an event that further compromises their quality of life by causing additional infections, hospitalizations and surgical procedures."
About End-Stage Renal Disease
In the United States, approximately 360,000 patients a year suffer from ESRD, or irreversible kidney failure. Approximately 70 to 80 percent of these patients need dialysis three times a week or a kidney transplant to survive. The hemodialysis treatment involves the insertion of two needles into the patient, one to channel the blood into the dialysis machine and the other to return the blood once filtered. Because normal blood vessels cannot withstand repeated needle insertion, AV grafts are surgically implanted in the patient's arm to provide more durable access. The majority of AV grafts is constructed of artificial conduit material.
AV graft failures are most often due to narrowing and blockage at the point of the graft-vein connection. This thickening of the interior vessel lining, known as neointimal hyperplasia, is similar to that seen in peripheral and coronary artery vein grafts. Failure of AV grafts is the leading cause of hospitalization of ESRD patients and constitutes almost one-third of the Medicare ESRD program expenditures for inpatient care. Corgentech is hopeful that treatment of AV grafts with CGT021 will reduce neointimal hyperplasia that causes these grafts to fail so frequently and quickly.
About CGT021
CGT021 is E2F Decoy, an oligonucleotide that binds to and inactivates the pivotal cell-cycle transcription factor E2F, administered in Corgentech's drug-delivery device. E2F is responsible for activating a dozen or more genes that must be turned on during vascular cell growth and multiplication. Its blockade prevents the proliferation of these abnormal cells that eventually result in graft failure.
About Corgentech Inc.
Corgentech Inc. is a privately-held biotechnology company that is the leader in the discovery, development and commercialization of an exciting and powerful new class of therapeutics called transcription factor decoys or TF Decoys. The Company's proprietary technology platform is capable of delivering multiple new product candidates to treat diseases that affect large patient populations in a relatively short period of time. Corgentech is based in Palo Alto, Calif. For more information on the company and its technology, visit www.corgentech.com.
| Contacts: | |
| Richard Powers Corgentech |
Kristin Nash WeissCom Partners |
| 650-624-9600 [email protected] |
415-302-7951 [email protected] |
