MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) presented data from an in-vitro
study evaluating receptor pharmacology of MAP0004, orally inhaled
dihydroergotamine (DHE) for the potential treatment of migraine, compared
to intravenous (IV) DHE. The study results were among six posters relating
to the MAP0004 program that the Company presented at the American Headache
Society 50th Annual Scientific Meeting in Boston, MA.
In this receptor pharmacology study, MAP0004 stimulated receptors that
relieve migraine at levels comparable to IV DHE, but did not activate
receptors associated with side effects frequently seen with IV DHE. In
addition, MAP0004 did not affect receptors that have a role in regulating
pulmonary function.
"The selective binding of MAP0004 at receptors associated with migraine
rather than those associated with side effects offers a mechanistic
hypothesis for the favorable safety and efficacy profile of MAP0004
compared to IV DHE that we have observed in our initial clinical studies,"
said Thomas A. Armer, Ph.D., Chief Scientific Officer of MAP
Pharmaceuticals. "The absence of negative effects of MAP0004 on pulmonary
function in asthmatic subjects observed in a Phase 2 study is also
important because migraine and asthma are frequently co-morbid conditions."
MAP0004 is designed to be self-administered by patients at home via MAP
Pharmaceuticals' proprietary Tempo(R) inhaler. In Phase 2 studies with
migraneurs and with asthmatics, treatment with MAP0004 was well-tolerated,
with no serious adverse events reported. Drug-induced nausea was very low
and migraine-associated nausea also decreased with treatment.
The Company presented a poster summarizing the receptor pharmacology
data entitled "Improved Dihydroergotamine (DHE) Pharmacology Following
Orally-Inhaled Delivery." In addition to this study, the Company presented
five posters relating to the MAP0004 program, including:
-- Newer Acute Migraine Specific Drugs May Provide Improved Sustained
Relief and Freedom Over 24 and 48 Hours Post Dosing
-- Chronic Inhalation Toxicological Assessment of Dihydroergotamine in
Dogs
-- Assessment of QTc Effect of DHE When Delivered Via the Lung by the
Tempo Inhaler
-- MAP0004, an Orally Inhaled Formulation of DHE, Delivers Faster and
More Consistent Blood Levels of the Drug Compared to Traditional Oral,
Subcutaneous, Intramuscular, and Intranasal Formulations of DHE
-- Systemic Pharmacokinetics of DHE When Delivered Via the Lung to
Asthmatics by the Tempo Inhaler
About MAP0004
MAP0004 is a proprietary orally inhaled version of dihydroergotamine,
or DHE, intended to treat migraine. In the Company's Phase 2 efficacy
study, MAP0004 provided pain relief as early as within ten minutes of
dosing, and this relief was sustained through at least 24 hours. The study
also demonstrated efficacy trends in treating nausea, photophobia and
phonophobia. Based on these results, as well as independent research that
concludes that patients prefer migraine therapies providing fast onset,
pain relief, sustained pain relief and safety, the Company believes that
MAP0004 has the potential to be a first-line therapy for migraine patients.
Historically, estimated onset of significant pain relief with oral
triptans, the class of drugs most often prescribed for treating migraine,
occurs between 45 and 90 minutes after dosing. In 2007, triptans generated
sales of approximately $2.2 billion in the United States, according to data
published by IMS Health.
MAP0004 is designed to be an easy to use, non-invasive, at-home therapy
that patients self-administer using the Company's proprietary hand-held
Tempo inhaler. DHE is currently available as an intravenous therapy which
has been used in clinical settings for over 50 years for the safe and
effective treatment of migraine, but requires healthcare intervention for
administration. In the Company's Phase 2 clinical efficacy study, MAP0004
was shown to retain the rapid onset and long-lasting effectiveness of
intravenous DHE while avoiding the nausea that intravenous administration
can cause.
About Migraine
Migraine is a common, debilitating neurological disease affecting
approximately 30 million people in the United States. It presents with
recurrent attacks of headaches, nausea, vomiting and sensitivity to light
and sound. Most migraines last between four and 24 hours, but some last as
long as three days. On average, migraine sufferers experience 1.5 migraine
attacks monthly, although 25% of them experience one or more attacks
weekly. Currently approved drugs for the treatment of an acute migraine
attack do not fully meet the needs of all patients due to the slow onset of
action, short duration of effect, inconsistent response, unacceptable side
effect profiles, or propensity to increase frequency of headaches with
these therapies.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals develops and plans to commercialize new therapies
for children and adults who suffer from chronic conditions that it believes
are not adequately treated by currently available medicines. The Company
applies its proprietary inhalation technologies to enhance the therapeutic
benefits and commercial attractiveness of proven drugs while minimizing
risk by capitalizing on their known safety, efficacy and commercialization
history. MAP Pharmaceuticals has two drug candidates, Unit Dose Budesonide
and MAP0004, in late stage development for the potential treatment of
pediatric asthma and migraine respectively. MAP Pharmaceuticals' pipeline
also includes a drug candidate in early clinical development for the
treatment of asthma and chronic obstructive pulmonary disease. Additional
information about MAP Pharmaceuticals can be found at
mappharma.
Forward-Looking Statements
In addition to statements of historical facts or statements of current
conditions, this press release contains forward-looking statements,
including with respect to our MAP0004 migraine program. Actual results may
differ materially from current expectations based on risks and
uncertainties affecting MAP Pharmaceuticals' business, including, without
limitation, risks and uncertainties relating to the development, clinical
testing and potential commercialization of our product candidates. The
reader is cautioned not to unduly rely on the forward-looking statements
contained in this press release. MAP Pharmaceuticals expressly disclaims
any intent or obligation to update these forward-looking statements, except
as required by law. Additional information on potential factors that could
affect MAP Pharmaceuticals' results and other risks and uncertainties are
detailed in its Quarterly Report on Form 10-Q, filed with the SEC on May
14, 2008, and available at edgar.sec.
MAP Pharmaceuticals, Inc.
mappharma
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