e8vk
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): November 29, 2006
EPIX PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
|
|
|
|
|
Delaware
|
|
000-21863
|
|
04-3030815 |
|
(State or Other
Jurisdiction of
Incorporation)
|
|
(Commission
File Number)
|
|
(IRS Employer
Identification No.) |
|
|
|
4 Maguire Road, Lexington, Massachusetts
|
|
02421 |
|
(Address of Principal Executive Offices)
|
|
(Zip Code) |
Registrants telephone number, including area code (781) 761-7600
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 (see General Instruction
A.2 below):
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 240.14a-12)
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))
TABLE OF CONTENTS
Item 7.01 Regulation FD Disclosure.
On November 29, 2006, EPIX Pharmaceuticals, Inc. (the Company) issued a press
release announcing the results of a Phase 2a clinical trial of its EP-2104R contrast agent. A copy
of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
This Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall
not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as
amended (the Exchange Act), or otherwise nor shall it be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the Exchange Act, except as explicitly set
forth by specific reference in such filing.
Item 8.01 Other Events
On November 29, 2006, the Company announced that the results from a Phase 2a clinical trial of
its EP-2104R contrast agent demonstrated that EP-2104R was able to detect blood clots not
previously seen on magnetic resonance imaging (MRI) and enhanced the images of clots previously
seen on MRI. The trial was designed to evaluate the efficacy of EP-2104R as a potential contrast
agent for use in MRI to detect acute thrombotic events.
The Phase 2a trial was an open-label study designed to examine the imaging qualities of
EP-2104R in a clinical setting. The Phase 2a trial included two studies with a total of 52
patients. The first study involved 14 patients in two cohorts:
(i) six patients in a pulmonary
embolism cohort; and (ii) eight patients in a deep vein thrombosis cohort. The second study
included 38 patients in four cohorts: (i) 15 patients in a carotid artery cohort; (ii) eight
patients in an atrial thrombus cohort; (iii) nine patients in a left ventricle cohort; and (iv)
six patients in a thoracic aorta cohort. All patients underwent an initial reference exam to
establish a diagnosis of the presence of thrombus, or a strong likelihood of the presence of
thrombus. Patients were given a 4 µmol/kg bolus dose of EP-2104R and contrast imaging was
performed within minutes. A second round of imaging was performed two to five hours following
administration of EP-2104R and some of the study participants underwent a third imaging session 24
hours after receiving EP-2104R. Clots were visualized from two to 24 hours following
administration of EP-2104R. Safety and tolerability of EP-2104R was also assessed, and EP-2104R
was well tolerated.
Item 9.01. Financial Statements and Exhibits.
|
|
|
99.1
|
|
Press Release issued by the Company on November 29, 2006, furnished herewith. |
-2-
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
EPIX PHARMACEUTICALS, INC.
|
|
Dated: November 29, 2006 |
By: |
/s/ Kim Drapkin
|
|
|
|
Name: |
Kim Drapkin |
|
|
|
Title: |
Chief Financial Officer |
|
|
-3-
EXHIBIT INDEX
|
|
|
Exhibit Number |
|
Description |
|
|
|
99.1
|
|
Press Release issued by the registrant on November 29, 2006, furnished herewith. |
-4-