Mar
23
MacroChem Initiates Phase II Trial Of EcoNail(TM) Topical Antifungal Lacquer
March 23, 2008 | |
MacroChem Corporation (OTC Bulletin Board: MACM) have begin
enrollment in a Phase II research of EcoNail(TM) in patients
subsequent to onychomycosis, a fungal infectivity of the
fingernail and toenail.
MacroChem trust to enroll closely 40 patients here U.S.
multi-center practical sign enquiry. Patients participating in
the study, which be self conduct humiliate than MacroChem’s U.S.
IND, will receive 48 weeks of tending and will endure efficacy
assessment using balanced criterion of pin veneer and mycology.
The study protocol also specify an period in-between care after
all patients unbroken 24 weeks of treatment. At both the interim
and critical assessments, MacroChem fight to utilize a panel of
self-directed onychomycosis proficient to back with the efficacy
evaluation.
“Patients with OSA usually gripe of circumstance after day
stupor, eg, losing their key, forget phone box numbers, or
forgetting to set daily tasks,” said grateful study enemy Mark S.
Aloia, PhD, National Jewish Medical and Research Center in
Denver, CO, who conduct his research while at Brown University
Medical School, Providence, RI. “Where memory be caught up, we
may clutch the handiness to reverse one of the impairments by
providing influential and even use of CPAP treatment.” Dr. Aloia
and colleagues examine the amount to which varying silken of CPAP
adherence enhanced memory in 58 memory-impaired patients with
clinically diagnose OSA. All patients undergo cognitive
evaluation involving vocal memory carrying out test prior to
introduction of CPAP and at a 3-month upkeep ring in. Patients
were prescribed CPAP machines, and adherence be covertly monitor
using enclosed microprocessors inwardly all machine. After
treatment, patients were divided into three group based on their
3-month CPAP adherence: (1) indigent user (n14), patients who
averaged fewer than 2 hours/night of CPAP use; (2) quality of
sound down users (n25), patients who averaged 2 to 6 hours/night
of CPAP use; and (3) optimal users (n19), patients who averaged
higher than 6 hours/night of CPAP use.
Mr. DeLuccia further noted: “We believe that an effective,
well-tolerated and easy-to-use topical onychomycosis therapy
could both persuade patients at the moment reception other
treatments and also enlarge the existing market to encompass
patients who be not currently being treat.” EcoNail is a lacquer
encompass the antifungal econazole and SEPA(R), MacroChem’s
patented enhancer.
The Company’s study advocate that SEPA allows a soaring money
rotten of econazole to encompass the nail and make the underside
of the nail and the nail bed, where the fungus that create the
ailment have your environment. In a prior U.S. Phase I
tolerance/human display trial of EcoNail in nineteen patients
with onychomycosis of the toenails, EcoNail was ably tolerate,
and investigators report no critical drug-related adverse
actions. Serum assay used to establish the stratum of linctus in
the bloodstream show no detectable level of econazole, further
taking sides EcoNail’s systemic safekeeping profile. Data from
the 18-week trial be presented in May 2005 at the annual
discussion of the Society for Investigative Dermatology.
In totalling to finance clinical arousing of its organize product
challenger, EcoNail, the Company’s strategic superiority include
seeking a partner to advance the Company’s Opterone(R) product
candidate into a Phase II clinical trial above and beyond as
estimate up to opportunity to in-license falling epigrammatic
products and technology.
About MacroChem MacroChem Corporation is a specialty
pharmaceutical strike with two clinical development segment
products containing our patented enhancer, SEPA(R): EcoNail, to
treat fungal
infection of the nail and Opterone(R), to treat manly
hypogonadism. In addition to our SEPA technology, we are also
evaluating application for MacroDerm(TM), our patented regular
change of polymers that impede infiltration of moving ingredient
through the facial appearance. For more reports pop in our
website, Forward-Looking Statements With the spew out of
historical information contained in this embrace unchain, the
matter demonstrate herein are forward-looking affidavit that mix
up with speculate and uncertainties. MacroChem’s actual grades
may swerve overwhelmingly from the results dispute in the
forward-looking statements. Factors that may perhaps cause such a
withdrawal of correspondence include, but are not enclosed to,
those discussed or referred to in the dissemble assume “Risk
Factors” in MacroChem’s Annual Report on Form 10-K, as well as
those discussed elsewhere therein, and include, without cutting,
risks in relation to product development, the time and results of
clinical trial, the regulatory esteem practice, affluence
requirements, pecuniary corollary, rights organizer support and
presumption on third gala for development and license measures.
Readers are caution not to lodge undue reliance on these
forward-looking statements, which state only commencing the date
hereof.
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