Osiris Therapeutics 8-K 2007
SECURITIES AND EXCHANGE COMMISSION
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): October 17, 2007
OSIRIS THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
Registrants telephone number, including area code: (443) 545 - 1800
(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 October 17, 2007, Osiris Therapeutics, Inc. issued a press release announcing the initiation of a Phase III pivotal clinical trial evaluating Prochymal as a first line agent in the treatment of acute Graft vs. Host Disease (GVHD), a life threatening complication of bone marrow transplantation that currently has no approved treatment. The primary endpoints of this pivotal trial includes remission rates and increased patient survival and are supported by data from the registrants Phase II trial for the same indication. 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.