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| HEPH > SEC Filings for HEPH > Form 8-K on 31-Mar-2009 | All Recent SEC Filings |
31-Mar-2009
Results of Operations and Financial Condition, Change in Dir
On March 31, 2009, Hollis-Eden Pharmaceuticals, Inc. (the "Company") issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2008 and certain other information. A copy of this press release is attached as Exhibit 99.1 to this report and incorporation by reference herein.
The information contained in this report, including the exhibit hereto, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act whether made before or after the date hereof, regardless of any general incorporation language in such filing.
(b) On March 29, 2009, the Company received notice from Thomas C. Merigan, Jr., M.D. that he had resigned from the Company's board of directors effective March 29, 2009 for personal reasons.
On March 27, 2009, the Special Committee (consisting entirely of non-employee directors and constituting a majority of directors) (the "Special Committee") of the Board of Directors (the "Board") of the Company removed Richard Hollis, the Company's former Chief Executive Officer, as Chairman of the Board and appointed Salvatore J. Zizza, a current director, as the non-executive Chairman of the Board.
On March 31, 2009, the Company included the following disclosure on p. 7 of its Annual Report on Form 10-K filed with the Securities and Exchange Commission on the same date:
"During 2008, Hollis-Eden initiated a Phase II clinical trial with TRIOLEX in type 2 diabetes patients. This Phase II, double-blinded placebo controlled 12-week dosing trial has enrolled over 90 patients with a hemoglobin A1c (HbA1c) level in excess of 7.5 percent who are on a stable dose of metformin only, the current first-line therapy for type 2 diabetes. The primary objectives of this trial are to evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group and to evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.
We have completed three interim analyses of data from this on-going Phase II clinical trial with TRIOLEX in type 2 diabetes patients. The first interim analysis, which we planned pursuant to the study protocol when 25 percent of the subjects reached study-day 57, was completed in December 2008. The second interim analysis was completed in January 2009 and then expanded
Enrollment in the trial is complete with 95 subjects. All subjects have completed dosing and we expect that the trial should be completed in the second quarter of 2009. We are evaluating all available data and will analyze the results from this study prior to determining the future development strategy for TRIOLEX in type 2 diabetes."
The information contained in this report, including the exhibit hereto, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act whether made before or after the date hereof, regardless of any general incorporation language in such filing.
By filing this Current Report on Form 8-K and furnishing this information, the Company makes no admission as to the materiality of any information in this Item 7.01 of Current Report on Form 8-K.
(d) Exhibits.
99.1 Press release dated March 31, 2009.
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