title: Double-blinded, Placebo-controlled plasmid GHRH trial for cancer-associated anemia in dogs.
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 (i.m.), followed by electroporation (EP), and were analyzed for up to 120 days. The response rate was defined as > or = 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.
authors.affiliation: VGX Pharmaceuticals, The Woodlands, Texas 77381, USA.
authors.forename: Angela M
authors.initials: AM
authors.lastname: Bodles-Brakhop
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Brown
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Pope
authors.forename: Ruxandra
authors.initials: R
authors.lastname: Draghia-Akli
mesh_terms: D000740:Anemia / Q000209:etiology* / Q000628:therapy* / Q000662:veterinary*; D000818:Animals; D002100:Cachexia / Q000628:therapy / Q000662:veterinary; D004283:Dog Diseases / Q000628:therapy*; D004285:Dogs; D004311:Double-Blind Method; D004912:Erythrocytes / Q000378:metabolism; D005260:Female; D015316:Genetic Therapy / Q000379:methods* / Q000662:veterinary*; D013007:Growth Hormone-Releasing Hormone / Q000627:therapeutic use*; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism; D007273:Injections, Intramuscular / Q000662:veterinary; D008297:Male; D009369:Neoplasms / Q000150:complications* / Q000628:therapy / Q000662:veterinary; D010919:Placebos; D011788:Quality of Life
chemical_list: D006454:Hemoglobins; D010919:Placebos; D013007:Growth Hormone-Releasing Hormone