I thought that CLTX hold all right (for ANY GENE therapy) on **via catheter delivery route**? What am I missing???
Tuesday November 13, 10:03 am Eastern Time
Press Release
SOURCE: Vascular Genetics Inc.
Studies Find VEGF-2 Improves Blood Flow and Eases Pain in Inoperable Heart Patients
Vascular Genetics Inc. Receiving Valuable FDA Input On Design of Critical Trial
ANAHEIM, Calif.--(BW HealthWire)--Nov. 13, 2001--Injecting VEGF-2, an angiogenic growth-factor, into oxygen-deprived hearts has been shown to promote new blood vessel development and improve blood flow in desperately ill patients, according to four related papers being presented at the American Heart Association's (AHA) 2001 Scientific Sessions, Anaheim, Calif., November 11-14, 2001. This body of work is being highlighted today at the AHA's Cellular Therapy press conference.
Marked Improvement in Angina
Nineteen patients, for whom conventional heart therapies had been exhausted, participated in a dose-escalating, double-blind trial that administered VEGF-2 via catheter. Of the 19 patients enrolled, 12 had VEGF-2 injected into the left ventricle of their heart. Two-thirds of these patients (8) showed a statistically significant reduction in angina, or chest pain, (ranging 50 to 75 percent) and one patient ceased experiencing angina altogether. None of the seven patients who received placebo experienced statistically significant improvement in angina. (Abstract ID: 112011)
``We have seen remarkable clinical improvement in these patients. With the decrease in angina, patients have been able to resume everyday activities,'' said lead investigator Peter R. Vale, M.D., St. Vincent's Hospital, Sydney, Australia. ``There are many patients with end-stage cardiovascular disease who no longer have options for treatment or surgery. If proven safe and efficacious, VEGF-2 could offer these individuals a non-invasive alternative.''
The VEGF-2 gene is exclusively licensed to Vascular Genetics Inc. from one of their investors, Human Genome Sciences, Inc. (NASDAQ: HGSI - news). The technology used to introduce the VEGF-2 gene, without using a viral vector, is licensed to Vascular Genetics from Vical Inc. (NASDAQ: VICL - news). Under terms of a cooperative agreement, Johnson & Johnson Inc. (NYSE: JNJ - news) furnished Vascular Genetics with its Myostar(TM) catheter for use in this study.
Increased Blood Flow to Heart Measured
VEGF-2 was also shown to increase blood flow to the heart using two objective measures. In one method, blood flow was monitored by SPECT imaging; and in the other approach, NOGATM electromechanical mapping was used. Until now, no currently approved therapeutic has demonstrated objective evidence of increasing blood flow in the heart.
SPECT Imaging
SPECT imaging uses nucleotides to measure blood flow to the heart muscle. Four weeks after treatment, an average of 23 percent improvement in blood flow was seen among five of the seven patients in the study (52 percent) who received VEGF-2. When only baseline-compromised areas were considered, a 42 percent improvement occurred within the same time frame. Researchers found this to be statistically significant, compared with no improvement seen in the placebo-controlled group of four patients. All of these patients had a history of heart attack and multiple revascularization procedures (an average of 4.8 angioplasties or cardiac bypass surgeries). Prior to treatment, their blood flow was measured at rest and after stress. (Abstract ID: 106223)
NOGA Electromechanical Mapping
Using the second measure, NOGA mapping showed that in patients receiving VEGF-2, the ischemic areas of their heart became dramatically smaller -- 1.3 cm after 12 weeks of therapy, compared to 7.1 cm before therapy. Those results reflected increased blood flow to compromised areas of the heart and correlated with clinical improvements in angina, tolerance for exercise and less need for medication. (Abstract ID: 112521)
Direct Myocardial Gene Transfer of VEGF-2 Demonstrates Clinical Improvement
In a related trial, VEGF-2 was administered directly into the heart through a small chest incision. The results demonstrated that most patients experienced a decrease in angina and an increase in exercise tolerance. In the 30 patients enrolled, all had end-stage coronary heart disease. Prior to treatment, 57 percent had severe angina (Class IV), and 43 percent had less severe angina (Class III). Post-treatment, after an average follow-up of 20 months, none of the patients had severe angina, 17 percent had less severe angina pain and 83 percent had marginal angina (Class I or II). Six patients had revascularization procedures, one of the remaining 29 patients had died, two had suffered nonfatal heart attacks and one had a stroke. (Abstract ID: 109261)
Vascular Genetics Inc. is a privately held company based in Waltham, Massachusetts, pursuing the development and commercialization of angiogenic gene transfer products for the use in patients with severe cardiac and peripheral vascular insufficiency. Vascular Genetics investors include Human Genome Sciences Inc., St. Elizabeth's Medical Center of Boston Inc., Cato Holding Company and Vical Inc. |
