RegeneRx Answers Questions Regarding Phase 2 Dry Eye Trial
ROCKVILLE, Md.--(BUSINESS WIRE)--Nov 4, 2011 - RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”). In response to questions received related to this morning's press release, RegeneRx wishes to publicly clarify certain points and information contained within the release.
|1.||Exploratory clinical trials, such as the RGN-259 Phase 2 dry eye trial, by nature and design, seek to identify areas where drug candidates show activity in order to specifically focus on those activities in future clinical trials;|
|2.||Whether the primary outcomes selected at the outset of an exploratory trial are met is less significant than identifying statistically significant outcomes that could potentially serve as approvable endpoints in pivotal Phase 3 trials;|
|3.||We believe that the statistically significant benefits observed in our exploratory Phase 2 trial are clinically relevant and indicate beneficial activity of RGN-259 when patients are challenged within a controlled adverse environment; and|
|4.||The statistical results identified in this morning's press release were derived on an intent-to-treat (ITT) population, which means that all randomized patients (72) were analyzed.|
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “believe,” “could,” “future,” “potential” or the negative of those words or other similar expressions to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include risks related to uncertainties inherent in our business, including, without limitation the risk that our product candidates do not demonstrate safety and/or efficacy in future clinical trials; risks related to our ability to obtain financing to support our operations on commercially reasonable terms; the progress, timing or success of our clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing our product candidates; regulatory developments; the size and growth potential of the markets for our product candidates and our ability to serve those markets; the scope and validity of patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and other risks described in the Company's filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the annual report on Form 10-K for the year ended December 31, 2010, filed with the SEC on March 31, 2011, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
Posted: November 2011