Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology
- Company targets new drug application submission -
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
CONTACT: Investors, Reid S. McCarthy, Vice President, Finance
and Chief
Financial Officer, Topaz Pharmaceuticals Inc.,
+1-267-960-3330,
info@topazpharma.com; Media,
Emily S. Poe, WCG, +1-212-301-7183,
epoe@wcgworld.com
Posted: July 2010
