Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology

HORSHAM, Pa., July 28 /PRNewswire/ -- Topaz Pharmaceuticals Inc., a privately held biotechnology company, announced positive results of studies of topical ivermectin cream, which it is developing as a potential  treatment of Pediculus humanus capitis (head lice).  

In a Phase 2 dose-ranging study presented at the annual meeting of the Society for Pediatric Dermatology in Portland, OR, this novel topical formulation produced a statistically significant eradication of live lice as compared to vehicle.  The results from another study presented at the meeting indicated that there was minimal plasma absorption of ivermectin when the topical formulation was applied to children as young as six months.

"Our foremost goal at Topaz is the successful development of topical ivermectin as a convenient application for the treatment of head lice infestations," said Thomas Beck, MD, Chief Medical Officer of Topaz Pharmaceuticals. "These results further support our belief that our topical ivermectin formulation has the potential to become an important treatment option. We anticipate concluding Phase 3 trials imminently and then to quickly progress to file a new drug application with the U.S. Food and Drug Administration."

Terri Meinking, PhD, President of Global Health Associates of Miami, Inc., presented a poster describing a dose determination study to establish the optimum concentration of ivermectin. The poster described a randomized, double-blind, dose-response study of 74 evaluable patients who received treatment with 0.15%, 0.25%, or 0.5% ivermectin, or vehicle.  All ivermectin concentrations (n=51) produced a statistically significant eradication of live lice at Day 15 compared to vehicle (p less than or equal to 0.003), with 0.5%, the concentration now in Phase 3 studies,  having the greatest efficacy of the three concentrations studied.

"The results from this phase 2 study are very encouraging," said Dr. Meinking. "Head lice can cause families tremendous anxiety and embarrassment, and parents are looking for a treatment that is safe and effective.  Ivermectin has a well-established record in treating other parasitic infections and this easy-to-use formulation shows great promise for treating head lice."

Lydie Hazan, MD, founder and CEO of Impact Clinical Trials, presented two studies in which the pharmacokinetics, safety and effectiveness of this 0.5% ivermectin cream were assessed in head lice-infested children.  Across the studies, children aged 6 months to 10 years were enrolled, including those weighing less than 15kg. Ivermectin was not detected in the plasma of any of the 10 children in the first study who were sampled.  In the second study, using a very sensitive test, detected levels of ivermectin  were less than 1% of those that occur when the tablet form of ivermectin is administered.  In both studies, there was a high level of elimination of head lice infestations in children treated with the 0.5% topical ivermectin formulation.

Impact of Head Lice

Head lice is a common condition that occurs throughout the world.(1)(2)  It is estimated that 6-12 million infestations occur each year in the United States, with infestations typically affecting children between the ages of three and 11.(3)  The social and economic burden of head lice can be significant,(4)(5)(6) and may lead to social ostracism, cause parental anxiety and act as a source of economic loss through missed school days and caregiver time off work.  Children found to be infested with head lice may not be allowed to return to school due to local no-nit policies.(7) Despite parents' best efforts to get rid of lice, current treatments are often ineffective, and safety and convenience issues have been associated with the available prescription treatments.

About Ivermectin

Ivermectin is a broad-spectrum antiparasitic agent that binds selectively to certain ion channels in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane, resulting in paralysis and death of the parasite. First developed from a soil bacterium isolated in 1974, widespread oral use of ivermectin began in 1987 in sub-Saharan Africa to control onchocerciasis (river blindness) in humans.  As of 2007, over 530 million doses of oral ivermectin, under the brand name Mectizan (registered trademark of Merck & Co.), had been administered as part of a river blindness eradication program.(8)  A novel topical form of ivermectin is currently under clinical investigation at Topaz as a potential therapy to treat head lice. 

About Topaz Pharmaceuticals

Topaz Pharmaceuticals Inc. is a privately held biotechnology company developing innovative treatments for the adult and pediatric markets. The company's lead product is a topic cream formulation of ivermectin, a broad spectrum parasiticide, under development for the treatment of head lice. The company is currently conducting two Phase 3 studies of ivermectin, both of which are expected to conclude in 2010. For more information about Topaz Pharmaceuticals Inc. please visit www.topazpharma.com.

References:

1. Burkhart CG. Relationship of treatment-resistant head lice to the safety and efficacy of pediculicides. Mayo Clinic Proc. 2004;79:661-666.
2. Falagas ME, Matthaiou DK, Rafailidis PI, et al. Worldwide prevalence of head lice. Emerg Infect Dis. 2008;14:1493-1494.
3. CDC. Centers for Disease Control and Prevention. Head lice fact sheet. Available at: http://www.cdc.gov/lice/head/factsheet.html. Accessed October 6, 2009.
4. Gordon S. Shared vulnerability: A theory of caring for children with persistent head lice. J School Nursing. 2007;23(5):283-292.
5. Gur I, Schneeweiss R. Head lice treatments and school policies in the US in an era of emerging resistance: A cost-effectiveness analysis. Pharmacoeconomics.2009;27(9):725-734.
6. Hansen R, O'Haver J. Economic considerations associated with Pediculus humanus capitis infestation. Clin Pediatr. 2004; 43:523.
7. Mumcuoglu KY, Meinking TA, Burkhart CN, Burkhart CG. Head louse infestations: the "no nit" policy and its consequences. Int J Dermatol. 2006;45:891–896.
8. Colatrella B. The Mectizan donation program: 20 years of successful collaboration—a retrospective. Annals of Tropical Medicine & Parasitology. 2008;102:S7–S11.

SOURCE Topaz Pharmaceuticals