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Critical Therapeutics Initiates Phase I Clinical Trial of the R(+) Isomer of Zileuton

Posted on: Monday, 1 October 2007, 09:00 CDT

Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced the initiation of a Phase I clinical trial to assess the safety and tolerability of an oral single dose of the R(+) isomer of zileuton in healthy subjects. R(+) zileuton combined in equal proportion with its mirror image isomer, S(-) zileuton, comprise racemic zileuton, which is the pharmaceutical ingredient in ZYFLO® (zileuton tablets) and ZYFLO CRTM (zileuton) extended-release tablets.

"We have generated preclinical data indicating that the R(+) isomer of zileuton could be a more potent leukotriene synthesis inhibitor with a more prolonged pharmacokinetic profile than the S(-) isomer," said Roger Rush, Ph.D., vice president, preclinical development for Critical Therapeutics. "We believe these characteristics may allow for the development of the R(+) isomer as a next generation leukotriene synthesis inhibitor that offers a reduced dosing and/or a smaller tablet size compared with ZYFLO CR. In addition to asthma, the successful development of the R(+) isomer may also allow for possible development opportunities in other diseases -- such as Chronic Obstructive Pulmonary Disease, atherosclerosis and nasal polyps -- in which the inhibition of the leukotriene pathway could provide benefit."

The Phase I clinical trial is a randomized, open-label, single dose, single center, two-period crossover trial designed to examine the safety, tolerability, pharmacokinetic and pharmacodynamic profile of the R(+) isomer of zileuton in healthy subjects. Twelve subjects will be randomly assigned to one of two groups of R(+) isomer zileuton (100 mg or 300 mg) (n=12). The trial is designed to confirm that the R(+) isomer of zileuton when dosed alone for the first time has the expected prolonged pharmacokinetic and potent pharmacodynamic profile.

About Critical Therapeutics

Critical Therapeutics, Inc. is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to two FDA-approved drugs for the prevention and chronic treatment of asthma in patients 12 years of age and older: twice-daily ZYFLO CRTM (zileuton extended-release tablets) and ZYFLO® (zileuton immediate-release tablets). Critical Therapeutics is developing products for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is developing therapies directed toward the body's inflammatory response. Critical Therapeutics is located in Lexington, Mass. For more information, please visit www.crtx.com.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding potential potency, dosing, future development, safety and efficacy of the R(+) isomer of zileuton, including the status and results of the Phase I clinical trial of the R(+) isomer, and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "anticipate,""believe,""could,""estimate,""expect,""intend,""may,""plan,""project,""should,""will,""would" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to: conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; our ability to successfully market and sell ZYFLO CR and ZYFLO, including the success of our co-promotion arrangement with Dey, L.P. (DEY); our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO CR and ZYFLO; patient, physician and third-party payor acceptance of ZYFLO CR and ZYFLO as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO CR and ZYFLO; our heavy dependence on the commercial success of ZYFLO CR; our ability to maintain regulatory approvals to market and sell ZYFLO CR and ZYFLO; our ability to successfully enter into additional strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; our dependence on our strategic collaboration with MedImmune, Inc.; and our ability to obtain, maintain and enforce patent and other intellectual property protection for ZYFLO CR and ZYFLO, our discoveries and our drug candidates. These and other risks are described in greater detail in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q and other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

ZYFLO® is a registered trademark of Critical Therapeutics, Inc.

ZYFLO CRTM is a trademark of Critical Therapeutics, Inc.

Source: Business Wire

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