MAP Pharmaceuticals Announces Initiation of LEVADEX(TM) Pharmacokinetics Trial

Name	Symbol	Market	Type
Harbor Multi asset Explorer ETF	AMEX:MAPP	AMEX	Exchange Traded Fund

Name

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Harbor Multi asset Explorer ETF

AMEX:MAPP

AMEX

Exchange Traded Fund

	Price Change	% Change	Price	High Price	Low Price	Open Price	Traded	Last Trade
	0.1402	0.64%	21.9476				0	21:15:02

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0.1402

0.64%

21.9476

21:15:02

MAP Pharmaceuticals Announces Initiation of LEVADEX(TM) Pharmacokinetics Trial

16/02/2010 12:00pm

PR Newswire (US)

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--Trial to be used in support of NDA submission-- MOUNTAIN VIEW, Calif., Feb. 16 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (NASDAQ:MAPP) today announced that the Company initiated a trial to compare the pharmacokinetics (PK), safety and metabolic profiles of LEVADEX(TM) orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine. This PK trial is one of two remaining trials to be initiated in support of a New Drug Application (NDA) submission for LEVADEX as previously requested by the U.S. Food and Drug Administration (FDA). In addition to the PK trial, the Company is conducting an ongoing 12 month open-label safety extension of its Phase 3 FREEDOM-301 trial, which has completed enrollment, and also plans to conduct a pharmacodynamic trial. The Company anticipates that patients in these trials will complete treatment in 2010. "Earlier this year, we announced that a second pivotal efficacy trial is not required for our NDA submission," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "The initiation of this PK trial is an important step for the Company as we continue to focus on completing our remaining clinical trials to support our NDA submission for LEVADEX." This PK trial is a single dose, open-label, crossover trial designed to compare the PK of LEVADEX to intravenous DHE in both smokers and non-smokers. The trial includes healthy adult volunteers, 24 of whom are smokers and 24 of whom are non-smokers. About LEVADEX(TM) LEVADEX orally inhaled migraine therapy is in Phase 3 development for the potential acute treatment of migraine. Patients administer LEVADEX themselves using the Company's proprietary TEMPO® inhaler. In the Phase 3 FREEDOM-301 trial, LEVADEX met all four co-primary endpoints at two hours: pain relief (p

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