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CRTX

Started by marsgold, February 24, 2007, 09:18:26 AM

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marsgold

Look like a new positive trend for the short term( 1 to 3 month).
Double bottom possible.

marsgold

I am not in for the moment.
Waiting monday to be sure.

MARS

setravis

(CRTX)
Critical Therapeutics Begins Phase II
Clinical Trial of Zileuton Injection for Asthma
Critical Therapeutics, Inc. (CRTX) began a Phase II clinical trial to assess
the effect on pulmonary function, safety, tolerability and pharmacokinetic
profile of zileuton injection, the Company's investigational compound
for adjunctive use with current therapies for acute exacerbations
of asthma. An injectable formulation of zileuton with current therapies
into the bloodstream has the potential to have a rapid onset of action
and may lead to faster symptom relief. The trial is designed to establish
the effect on pulmonary function from a single intravenous dose
of zileuton injection at two different dose levels. A previous Phase I/II
clinical trial was completed in 2006 for injectable formulation of zileuton
for adjunctive use in emergency room or urgent care settings with patients
experiencing acute exacerbations of asthma. The trial indicated a
greater percentage improvement than patients in the placebo group. In
the severe asthma market, competition results primarily from the therapies
developed for mild to moderate asthma, such as Merck's (MRK)
Singulair(R), GlaxoSmithKline's (GSK) Advair(R) and inhaled corticosteroids
that are used in combination or as add-on therapies, along
with oral and injectable steroid treatments. Xolair(R) was developed
jointly by Novartis AG (NVS) and Genentech, Inc. (DNA). AstraZeneca
(AZN) has commercially launched Symbicort(R), a twice-daily asthma
therapy combining budesonide, an inhaled corticosteroid, and formoterol,
a long-acting beta2-agonist, which is expected to compete in the
moderate and severe asthma markets. Many therapies for COPD are
already well established in the respiratory marketplace, including Sepracor,
Inc.'s (SEPR) Brovana(R), GlaxoSmithKline's (GSK)Advair(R)
and Serevent(R) and Spiriva(R), a once daily muscarinic antagonist
from Boehringer Ingleheim GmbH and Pfizer (PFE). The Company is
focused on developing and commercializing innovative products for respiratory,
inflammatory and critical care diseases. It owns the worldwide
rights to two FDA-approved drugs, ZYFLO(R)(zileuton tablets) and ZYFLO
CR(TM)(zileuton) extended-release tablets, for the prevention and
chronic treatment of asthma in patients 12 years of age and older. Zileuton
inhibits the production of 5-lipoxygenase (5-LO), the main enzyme
responsible for the production of leukotrienes, a family of inflammatory
mediators that can trigger asthma symptoms, including inflammation,
swelling, bronchoconstriction and mucus secretion. ZYFLO and ZYFLO
CR have a unique mechanism of action that works early in the inflammatory
cascade, thus blocking all types of leukotrienes. Some of the most
common side effects associated with the use of ZYFLO are abdominal
pain, upset stomach and nausea. The Company has also signed an
agreement to jointly promote PERFOROMIST(TM) (formoterol fumarate)
Inhalation Solution with Dey L.P., an affiliate of Merck KGaA, for
the treatment of chronic obstructive pulmonary disease, or COPD. The
agreement has a term expiring on December 31, 2013, which may be
extended upon mutual agreement. In addition to an injectable formulation
of zileuton, the Company's other development programs includes
preclinical testing of R(+) isomer of zileuton that shows a high potency
for 5-lipoxygenase inhibition and exhibits a prolonged plasma pharmacokinetic
exposure profile. Plans are to initiate a Phase I clinical trial in
the third quarter of 2007. The Company's alpha-7 program, which is directed
at the discovery and development of novel small molecule drugs
for the treatment of inflammation, has selected a lead compound that
is currently in preclinical development. The Company continues to collaborate
with MedImmune, Inc. on the development of a human monoclonal
antibody to the cytokine HMGB1. The collaboration has narrowed
down potential clinical candidates to one fully-human antibody that has
shown efficacy in pre-clinical models of arthritis and lupus. The Company
recognized $2.3M of revenue from product sales of ZYFLO in the
three months ended June 30, 2007 compared to $1.8M in three months
ended June 30, 2006. Total revenue for the three months was $3.4M,
compared with $3.5M for the same period in 2006. The Company posted
a net loss of $0.30 per share versus $0.42 per share for the same
period in 2006. The Company had an accumulated deficit of $172.0M
and cash and short-term investments that totaled $40.5M.
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

(CRTX)
BEGINS ENROLLMENT FOR PH III TRIAL: Critical Therapeutics (CRTX) announced the start
of patient enrollment for a Phase III randomized, double-blind, placebo-controlled efficacy trial to
examine the effects of ZYFLO(R) (zileuton tablets) used in the treatment of adults with Chronic
Obstructive Pulmonary Disease (COPD). The purpose of this trial is to examine the effectiveness
of ZYFLO at reducing the length of a hospital stay for adults who are hospitalized for a COPD
exacerbation, or a worsening of their COPD symptoms. Secondary outcomes will include lung
function improvement, "treatment failure" at 30 days, health-related quality of life and urinary leukotriene
levels. This clinical trial is being sponsored and funded by the National Heart, Lung and
Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and is being conducted by
the COPD Clinical Research Network (CRN).
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis