UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 23, 2009
OSIRIS THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware | | 001-32966 | | 71-0881115 |
(State or other jurisdiction of
incorporation) | | (Commission File Number) | | (IRS Employer
Identification No.) |
| | | | |
7015 Albert Einstein Drive, Columbia, Maryland | | 21046 |
(Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (443) 545 - 1800
Not Applicable
(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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
ITEM 7.01 Regulation FD Disclosure
On June 23, 2009, Osiris Therapeutics, Inc. issued a press release announcing the interim six-month data from its Phase II double-blind, placebo-controlled study of 62 patients to evaluate the safety of Prochymal® in conjunction with standard of care in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”). The six-months data showed that the trial met its primary goal of demonstrating the safety of Prochymal in patients with compromised pulmonary function at the six-month evaluation point; Prochymal significantly decreased systemic inflammation in patients when compared to those receiving placebo, as determined by C-reative protein; and despite the reduction in inflammation, pulmonary function in patients receiving Prochymal was not significantly improved compared to those receiving placebo. The full text of the press release is furnished 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
(d) Exhibits.
99.1 Registrant’s press release dated June 23, 2009
Information presented in this Current Report on Form 8-K may contain forward-looking statements and certain assumptions upon which such forward-looking statements are in part based. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Risks and that could cause our actual results to differ materially from those anticipated in forward-looking statements, include the factors described in the sections entitled “Risk Factors” in our Annual Report on Form 10-K filed with the United States Securities and Exchange. You should not unduly rely on forward-looking statements.
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SIGNATURES
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.
| OSIRIS THERAPEUTICS, INC. |
| |
Dated: June 25, 2009 | By: | /s/ PHILIP R. JACOBY, JR. |
| | Philip R. Jacoby, Jr. |
| | Vice President of Finance (principal accounting officer) |
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EXHIBIT INDEX
Exhibit No. | | Description |
| | |
99.1 | | Registrant’s press release dated June 23, 2009 |
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