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
- 1VGX Pharmaceuticals, The Woodlands, Texas, USA
- 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.
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
2.5 years, weight 24.9
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
5%
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
26 days post-treatment, while nonresponders and controls survived for 95
16 and 97
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.
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