Osiris Therapeutics 8-K 2007
WASHINGTON, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 25, 2007
OSIRIS THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
Registrants telephone number, including area code: (410) 522 - 5005
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
ITEM 7.01 Regulation FD Disclosure
On March 25, 2007, Osiris Therapeutics, Inc. issued a press release announcing positive six-month results from its 53 patient Phase I study using ProvacelTM for the treatment of patients with heart disease. The double-blind, placebo-controlled study evaluated the safety and preliminary efficacy of the intravenous administration of Provacel, an adult mesenchymal stem cell therapy. Heart attack patients receiving the therapy had significantly lower rates of adverse events, such as cardiac arrhythmias, as well as significant improvements in heart, lung and global function. Administration of Provacel was found to be well tolerated at all dose levels. The press release is attached hereto as an exhibit to this Current Report on Form 8-K and is being filed pursuant to this Item 7.01 as Exhibit 99.1 to this Current Report on Form 8-K.
The information included herein, including Exhibit 99.1 furnished herewith, shall not be deemed to be filed for purposes of Section 18 of the Securities Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such filing.
ITEM 9.01. Financial Statements and Exhibits
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.