SAN DIEGO, CA, Sept. 7 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation (TSX: NVN - News) today announced the presentation of positive results from a clinical trial examining the safety and efficacy of HspE7, an investigational therapeutic vaccine for human papillomavirus (HPV)-related diseases, on HIV-negative men with internal anal condyloma or genital warts. The data were presented by Stephen E. Goldstone, M.D., the investigator in the trial and an expert in the field of HPV-related diseases, at the 23rd International Papillomavirus Conference taking place from September 1st until September 7th in Prague, The Czech Republic.
“Consistent with a previously conducted trial, HspE7 demonstrated activity in treating anal genital warts in men, with most patients (81 percent) showing no warts or marked improvement,” said Dr. Goldstone, a Fellow of the American College of Surgeons and clinical assistant professor at The Mount Sinai School of Medicine in New York City. “Although complete response (CR) remains the therapeutic objective, the partial response seen here, which resulted in a significant decrease in the extent of the disease, provided a marked clinical benefit because additional ablative therapy was rendered easier and more tolerable. In addition,” Dr. Goldstone continued, “while the data did not indicate that the higher dose of HspE7 improved response rate or decreased response time, the data did demonstrate that external warts responded as well or better than internal warts, something not seen in earlier clinical trials.” Gregory M. McKee, President and Chief Executive Officer of Nventa commented on the study: “These data provide additional evidence of the activity of HspE7. As we announced previously, we plan to combine HspE7, our lead product candidate, with the adjuvant Hiltonol. We believe HspE7 plus Hiltonol may produce even better results through improvement in the response rate or decrease in response time.”
Trial Design
This Phase II study was a single-arm study in 30 patients, three of whom withdrew prior to completion. All of the patients had internal genital warts and 10 also had external genital warts. Three monthly injections of 1500 mcg of HspE7 were given and the patients were followed for 48 weeks. Response was gauged by clinical assessment, photographs and measurement of all warts through high-resolution anoscopy. CR was defined as absence of warts. Through a previous trial, three monthly doses of 500 mcg of HspE7 were shown to be active in clearing anal genital warts with a CR rate of 42 percent at 24 weeks. This trial was designed to determine the safety and efficacy of a higher dose of HspE7.
Trial Results
At week 24, three men (11 percent) had CR while 18 (67 percent) had improved. By week 48, nine men (33 percent) had CR while 13 (48 percent) improved, with a mean decrease in volume of the genital warts of 71 percent. Three men (11 percent) worsened, while two men (7 percent) had no change. Of the 10 men with external genital warts, seven (70 percent) had CR and one (10 percent) improved by 48 weeks. Twenty-eight men (93 percent) reported at least one adverse event, with headache in eight (27 percent) being the most common.
About HspE7, Lead Product Candidate:
HspE7 is a novel therapeutic vaccine candidate for the treatment of diseases caused by the human papillomavirus (HPV), one of the most common sexually transmitted diseases in the world. HspE7 is derived from Nventa’s proprietary CoVal(TM) fusion platform, which uses recombinant DNA technology to covalently fuse stress proteins to target antigens, thereby stimulating cellular immune system responses. Stress proteins, also known as heat shock proteins (Hsps), are naturally present in the human body and play important roles in the immune system, including transporting substances within cells and activating cells of the immune system. Nventa is pursuing clinical development of HspE7 in combination with the adjuvant Hiltonol, or Poly-ICLC, which has been shown to activate innate immunity and targets the Toll-like receptor 3 (TLR-3) pathway.
About Nventa Corporation:
Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by the human papillomavirus (HPV). The corporation is publicly traded on the Toronto Stock Exchange under the symbol NVN. For more information about Nventa, please visit the website located at www.nventacorp.com.
CONTACT: Donna Slade, Director, Investor Relations, 6055 Lusk Boulevard, San Diego, CA, USA, 92121, Dir: (858) 202-4945, dslade@nventacorp.com
Source: Nventa Biopharmaceuticals Corporation
