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Oculus Innovative Sciences Provides Update of Phase II Study for Microcyn(R) Technology in Mildly Infected Diabetic Foot Ulcers.


Phase II Update Conference Call Scheduled for Monday, Sept. 17 at 9:00 am EDT EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

EDT 
 

CHICAGO -- Oculus oculus

(Latin: “eye”) In architecture, any of several elements resembling an eye, such as a round or oval window or the round opening at the top of some domes (see Pantheon).
 Innovative Sciences, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:OCLS OCLS Off-Campus Library Services ) today announced that it held an investigator meeting yesterday at the Interscience Conference on Antimicrobial Agents and Chemotherapy Antimicrobial Agents and Chemotherapy (print-ISSN 0066-4804, CODEN AMACCQ; canceled ISSN 0074-9923, canceled CODEN AACHAX) is an academic journal published by the American Society for Microbiology.  in Chicago. The meeting included a review of the ongoing Phase II clinical study underway, a review of potential trial design and plans for the Phase III trials.

Sixteen medical centers and clinics across the United States are participating in the current Phase II trial, which is a 60-patient, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 and open-label Phase II study to evaluate the preliminary safety and efficacy of topical Microcyn[R] Technology for the treatment of mildly infected diabetic foot infections Diabetic Foot Infections Definition

Diabetic foot infections are infections that can develop in the skin, muscles, or bones of the foot as a result of the nerve damage and poor circulation that is associated with diabetes.
. The primary efficacy endpoint of the trial is clinical cure or improvement of infection. This study is designed as a proof of concept that the company expects will provide the required basis for taking Microcyn Technology into Phase III clinical trials.

The company has enrolled and randomized 42 patients of the total 60 targeted patients. Over the past month, enrollment has increased with three to five new patients enrolled each week on average. Oculus now expects to announce completion of the trial in Q4 of this year followed by the final results from the Phase II study to be announced To be announced (TBA)

A contract for the purchase or sale of an MBS to be delivered at an agreed-upon future date but does not include a specified pool number and number of pools or precise amount to be delivered.
 in Q1 of 2008. To date, there have been no reports of serious adverse events in patients in the Phase II trials requiring expedited reporting to FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
.

Phase II and Phase III Protocols

The design of the Phase II study was endorsed by an independent board of advisors who met in Seattle in July to discuss design options for the Phase III program. The independent advisory board recommended that essentially the same design as the Phase II trial should be pursued in the Phase III studies.

"We look forward to the successful completion of this trial and what we believe to be the clear validation of the Microcyn Technology to the investor community," said Hoji Alimi, Oculus president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. .

Phase II Conference Call

Oculus president and CEO, Hoji Alimi, will hold a conference call on Monday, September 17, 2007 at 9:00 a.m. (EDT) to update investors on the Phase II study and the clinical development plan. To participate in the conference call, please call 1-877-407-4018 (domestic/toll-free) or 1-201-689-8471 (international). A telephone replay will be available for 48 hours after the call at 1-877-660-6853 (domestic/toll-free), or 1-201-612-7415 (international). Please enter account number 3055 and conference identification number 255635.

About Oculus

Oculus Innovative Sciences is a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn[R] Technology platform, which is intended to help prevent and treat infections in chronic and acute wounds. The Microcyn Technology platform is a controlled slow-release solution containing active chlorine and other gases resulting in a biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function.  technology to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria, viruses, fungi and spores. The technology has demonstrated significant wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by  in chronic and acute wounds. It has been commercialized outside of the U.S. for the treatment of infected wounds. It is currently under evaluation for the treatment of mildly infected diabetic ulcers in the U.S.

Oculus' principal operations are in Petaluma, California, and it conducts operations in Europe, Latin America and Japan through its wholly owned subsidiaries, Oculus Innovative Sciences Netherlands B.V., Oculus Technologies of Mexico, S.A. de C.V. and Oculus Japan K.K. Oculus' website is www.oculusis.com.

Forward-Looking Statements

Except for historical information herein, some matters set forth in this press release are forward-looking within the meaning of the "safe harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
" provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, including statements about our ability to replicate the results of the test in clinical trials, if at all, or for such trials or other tests to establish the conclusions suggested by the results of the test. These forward-looking statements are identified by the use of words such as "believe" "suggest," "could involve," "could be considered," "intended," "goal" and "designed," among others. These forward-looking statements are based on Oculus Innovative Sciences, Inc.'s current expectations. Investors are cautioned that such forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company's business including risks inherent in the development and commercialization of potential products, the risk that scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, risks that revenues will not reach expected levels, the risk that additional time may be required to achieve evaluable enrollment that is consistent with the Phase II study design, the Company's future capital needs, and its ability to obtain additional funding and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including the quarterly report on Form 10-Q for the quarter ended June 30, 2007 and Form 10-K for the fiscal year ended March 31, 2007. Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements.

Oculus and Microcyn are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and services marks are the property of their respective owners.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved.

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Publication:Business Wire
Article Type:Clinical report
Date:Sep 17, 2007
Words:869
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