Original Article

Subject Category: Acquired and Multigenic Disease

Molecular Therapy (2008); 16 5 862–870 doi:10.1038/mt.2008.31

Double-blinded, Placebo-controlled Plasmid GHRH Trial for Cancer-associated Anemia in Dogs

Angela M Bodles-Brakhop1, Patricia A Brown2, Melissa A Pope1 and Ruxandra Draghia-Akli1

  1. 1VGX Pharmaceuticals, The Woodlands, Texas, USA
  2. 2VGX Animal Health, The Woodlands, Texas, USA

Correspondence: Ruxandra Draghia-Akli, VGX Pharmaceuticals, Inc., 2700 Research Forest Drive, Suite 180, The Woodlands, Texas 77381, USA. E-mail: rdraghia@vgxp.com

Received 10 October 2007; Accepted 31 January 2008; Published online 18 March 2008.

Top

Abstract

The use of growth hormone releasing hormone (GHRH) plasmid–based therapy to treat companion dogs with spontaneous malignancies and anemia receiving a cancer-specific treatment was examined in a double-blinded, placebo-controlled trial. The dogs (age 10.5 plusminus 2.5 years, weight 24.9 plusminus 12.9 kg) received a single 0.35 mg dose of plasmid or placebo intramuscularly (IM), followed by electroporation (EP), and were analyzed for up to 120 days. The response rate was defined as greater than or equal to5% increase above the nadir in the red blood cell (RBC), hemoglobin (Hb), and hematocrit (Ht) levels. Plasmid-treated dogs had at least a 7% increase in all three parameters. The initial response rates for the plasmid-treated dogs were 40.6 and 35.5% , respectively on days 40 and 60, which increased to 54.2% on day 90. Although the response rate reduced to 47.1% by day 120, it was still 22.1% higher than in the control dogs. Post-hoc analysis of the GHRH-treated group showed that responder dogs survived 84% longer, 178 plusminus 26 days post-treatment, while nonresponders and controls survived for 95 plusminus 16 and 97 plusminus 31 days post-treatment, respectively. The quality of life, defined by 10 different parameters, dramatically improved with treatment. Overall, the possibility of a GHRH plasmid–based therapy for anemia in cancer-afflicted subjects is important enough to deserve further investigation.

Extra navigation

.
ADVERTISEMENT