8-K

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):  11/12/2009

Hollis-Eden Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Commission File Number:  -

DE	13-3697002
(State or other jurisdiction of	(IRS Employer
incorporation)	Identification No.)

4435 Eastgate Mall, Suite 400, San Diego, CA 92121

(Address of principal executive offices, including zip code)

858.587.9333

(Registrant’s telephone number, including area code)

(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:

[  ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01.    Other Events

On November 12, 2009, Hollis-Eden Pharmaceuticals, Inc. issued a press release announcing the presentation of additional interim data from its ongoing human clinical Phase I/II open-label dose-ranging trial with Apoptone (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC) on November 16 at the American Association for Cancer Research - Molecular Targets and Cancer Therapeutics Conference in Boston. The Company also provided an update on the clinical development of Triolex for: obese, insulin-resistant diabetic patients; Type 2 diabetes; rheumatoid arthritis; and ulcerative colitis. The foregoing description is qualified in its entirety by reference to the press release, a copy of which is attached as Exhibit 99.1 to this report and incorporation by reference herein.

On November 16, 2009 - Hollis-Eden Pharmaceuticals, Inc. issued a press release announcing new interim data from its ongoing Phase I/II clinical trial with Apoptone (HE3235) for hormone-r esistant prostate cancer (also called castrate-resistant prostate cancer or CRPC), presented at the Molecular Targets and Cancer Therapeutics Conference in Boston, which is co-sponsored by the AACR, NCI and EORTC. The foregoing description is qualified in its entirety by reference to the press release, a copy of which is attached as Exhibit 99.2 to this report and incorporation by reference herein.

The information contained in this report, including the exhibits 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 unless expressly set forth by specific reference in any such filing.

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.

		Hollis-Eden Pharmaceuticals, Inc.
Date: November 16, 2009	By:	/s/    /Robert Weber/
		Robert Weber
		Chief Financial Officer

EXHIBIT INDEX

Exhibit No.	Description
EX-99.1	Press Release dated November 12, 2009
EX-99.2	Press Release dated November 16, 2009

EX-99.1

CONTACT: Robert Weber

Chief Financial Officer

Hollis-Eden Pharmaceuticals

Telephone: (858) 587-9333

Email: rweber@holliseden.com

Hollis-Eden to Present Interim Data from its Phase I/II Clinical Studies of Apoptone® (HE3235) at Molecular Targets and Cancer Therapeutics Conference

- Company Provides Update on Progress of Lead Compounds -

San Diego, CA - November 12, 2009 - Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH), will present results of its ongoing human clinical Phase I/II open-label dose-ranging trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC) on November 16 at the American Association for Cancer Research - Molecular Targets and Cancer Therapeutics Conference in Boston. Apoptone, a novel steroid that is an analog of part of the dihydrotestosterone metabolic pathway, stimulates ERK1 signal transduction that counter-regulates PI3K, and thereby initiating tumor cell apoptosis. Apoptone has demonstrated activity in animal models of CRPC, the results of which were recently published in the British Journal of Cancer and the journal Neoplasia.

Concurrently with its lead program Apoptone, Hollis-Eden Pharmaceuticals is pursuing clinical development of a second oral small-molecule candidate, Triolex®, from its synthetic steroid library. Triolex decreases macrophage infiltration into fatty tissues and pro-inflammatory processes. The lead indication for Triolex is Type 2 diabetes. A Phase II trial (HE3286-0401) in obese, insulin-resistant diabetic patients is fully enrolled and should be completed in the first quarter of 2010. A Phase I trial (HE3286-0102) to assess safety and early activity in obese insulin-resistant, pre-diabetic subjects is complete, with final analysis in progress. Additional trials were initiated during 2008 in rheumatoid arthritis (RA) and ulcerative colitis (UC).

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James Frincke, Ph.D., Chief Executive Officer of Hollis-Eden Pharmaceuticals commented: "We have reduced our burn rate to enable operations focused on our lead programs to continue into the latter half of 2010. We intend to use data from our ongoing trials to engage with potential corporate partners for the design and funding of late-stage development programs in diseases with high unmet medical need."

Triolex Clinical Program Update

Diabetes

Pre-diabetes Phase I safety tolerance and early activity trial HE3286-0102

This study has completed the planned enrollment of 48 patients and data analysis has been initiated. Preliminary results indicated that Triolex was safe and well-tolerated, and there were no side effects observed such as those seen with testosterone, estrogen, progesterone or glucocorticoids.

Diabetes Phase II two-stage exploratory and confirmatory trial HE3286-0401

This ongoing study in type 2 diabetic patients was undertaken based on promising Triolex activity in insulin-resistant, prediabetic subjects. The original study began in the second half of 2008. The initial exploratory phase included 84 days of treatment with Triolex or placebo along with metformin in patients with uncontrolled HbA1c levels. Activity was found in a subset of diabetics defined with biomarkers as obese, inflamed and insulin-resistant. A confirmatory, placebo-controlled trial was initiated in the second quarter of 2009 in patients dosed only with Triolex or placebo in order to avoid potential confounding effects of metformin on anti-inflammatory activity. The confirmatory stage of the trial is fully enrolled; the last patient is expected to complete the trial in the first quarter of 2010.

Other Inflammatory Diseases

Two exploratory Phase I/II studies were initiated with Triolex in other diseases with an auto-immune inflammatory etiology. The results of these studies, combined with our completed non-clinical long-term toxicology data, will permit proof-of-concept trials in these indications as resources become available.

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Ulcerative colitis Phase I/II safety, tolerance and early activity trial HE3286-0301

This Phase I/II trial explored the safety, tolerability and early signs of activity in chronic UC patients who were experiencing an acute flare in their disease. Patients were dosed for 28 days at 3 dose levels: 5 mg, 10 mg (5 bid) and 20 mg (10 bid) and Triolex was found to be safe and tolerable. Adverse events were mild to moderate and equally divided between Triolex and placebo-treated groups. The study was not powered to show statistically significant activity differences between placebo and drug-treated patients based on disease score changes. There was no clear separation between the placebo and active study arms over a one-month treatment period.

Rheumatoid arthritis Phase I safety, tolerance and drug compatibility study HE3286-0201

This Phase I safety and tolerance study was conducted in RA patients with stable disease that were concurrently taking methotrexate as maintenance therapy. A secondary objective of the study was to learn whether Triolex interfered with the action of methotrexate, which is required for concomitant dosing trials in patients with active disease. Three dose levels of Triolex were given daily to 14 subjects for 28 days along with weekly methotrexate. Three patients were dosed at 10 mg (5 mg bid), three at 20 mg (10 mg bid) and eight at 40 mg (2 mg bid) on an intent-to-treat basis.

Triolex was found to be safe and well tolerated. No disease flares or increased methotrexate toxicity were observed. Most adverse events were mild to moderate. Subject drug exposure remained dose proportional through the higher dose, and no change in methotrexate or Triolex pharmacokinetics was observed.

About Hollis-Eden Pharmaceuticals

Hollis-Eden Pharmaceuticals is a development-stage company with two product candidates in human clinical trials: Apoptone (HE3235), in the dose-escalation portion of a Phase I/II trial of patients with late-stage prostate cancer, and Triolex, in a Phase IIa trial in obese Type 2 diabetes patients. Apoptone and Triolex represent the lead candidates from Hollis-Eden's small molecule platform based on metabolites or synthetic analogs of endogenous steroid hormones. For more information on Hollis-Eden please visit www.holliseden.com.

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This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, the presentation of the results of Hollis-Eden Pharmaceuticals, Inc. ongoing human clinical Phase I/II open-label dose-ranging trial with Apoptone (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC) on November 16; the completion of Hollis-Eden's Phase II trial (HE3286-0401) in obese, insulin-resistant diabetic patients in the first quarter of 2010; the continuation of Hollis-Eden's operations focused on its lead programs into the latter half of 2010; Hollis-Eden's use of data from its ongoing trials to engage with potential corporate partners for the design and funding of late-stage development programs; and Hollis-Eden's ability to conduct proof-of-concept trials in other diseases with an auto-immune inflammatory etiology as resources becomeavailable. Any statement included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause Hollis-Eden's actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in the Company's business, including, but not limited to: the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to obtain regulatory approval for TRIOLEX (HE3286), APOPTONE (HE3235) or any other investigational drug candidate; the Company's future capital needs; the Company's ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual pro perty rights of others; the development of competitive products by other companies; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, Hollis-Eden undertakes no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.

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EX-99.2

CONTACT: James Frincke, Ph.D.

President and CEO

Hollis-Eden Pharmaceuticals

(858) 587-9333

IR@holliseden.com

Hollis-Eden Presents New Interim Data from Prostate Cancer Phase I/II Clinical Studies of Apoptone (HE3235) at AACR Molecular Targets and Cancer Therapeutics Conference

Boston, MA - November 16, 2009 - Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH), today reported preliminary results of its ongoing Phase I/II clinical trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC). Presented at the Molecular Targets and Cancer Therapeutics Conference, which is co-sponsored by the AACR, NCI and EORTC, the poster is titled:"Results of preclinical and clinical Phase I/II open-label dose-ranging trial with HE3235, a synthetic adrenal hormone, in Castrate Resistant Prostate Cancer (CRPC)." Apoptone (HE3235), a novel steroid that is an analog of a dihydrotestosterone metabolic pathway member, stimulates cell death (apoptosis) in hormone-dependent prostate tumors. Presenting the data is the lead investigator of the study, R. Bruce Montgomery, M.D., Associate Professor, Department of Medicine, Division of Oncology, University of Washington School of Medicine. The poster also included supportive preclinical data.

The interim results of the Phase I/II study, which is being conducted with participating member sites of the Prostate Cancer Clinical Trial Consortium (PCCTC), demonstrated that 47% of subjects who were radiographically evaluable for response had stable disease. With the assessment of progression every 56 days, the median time to progression was 107 days. Forty-three percent of the biochemically evaluable subjects experienced a drop in PSA during treatment, with 33 % equal to or greater than a 50% decline.

Individuals experienced increases in PSA with stable disease. Plasma PSA increases are expected because the mechanism of action is believed to involve inhibition of tumor cell proliferation while the androgen receptor transcription element is engaged, independent of the androgen receptor. This results in an increase in tumor cell PSA expression followed by induction of apoptosis, which releases PSA into circulation. As tumor cell death occurs, the PSA is expected to decline or stabilize.

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"Based on the encouraging responses and the tolerability profile we have seen in these end-stage patients, we are dose-escalating to 200 mg per day," commented Dr. Montgomery. "As we track time to progression through further treatment cycles, we expect that PSA levels will remain stable or continue to decline, consistent with the unique mechanism of this drug, which is distinct from other compounds in later-stage development for CRPC."

Howard Scher, M.D., Chief of the Genitourinary Oncology Service at the Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan-Kettering and Principal Investigator of the PCCTC, added: "These data provide initial evidence of activity in late-stage prostate cancer. The next step will be to expand the subject eligibility criteria to include earlier-stage, chemotherapy-naive patients in a controlled Phase II trial."

APOPTONE Clinical Trial Design

The study is an open-label study with the primary objective of assessing safety, tolerance, PK and activity of Apoptone in men with CRPC and an ECOG PS of <2 who failed at least one taxane-containing chemotherapy regimen and either radiographically or biochemically progressed. Patient cohorts are defined by oral twice-daily doses of 10 mg, 20 mg, 30 mg, 50 mg, 100 mg or higher (MTD has not yet been reached). Subjects are treated on 28-day cycles until toxicity or disease progression; CT and bone scans are obtained every two cycles to assess progression.

About Prostate Cancer

Over one million men in the United States have prostate cancer; approximately 90,000 of these patients have late-stage prostate cancer, resulting in approximately 28,000 deaths each year. There are currently no approved treatments for end-stage (hormone and chemotherapy refractory) prostate cancer and the survival time is estimated to be between 8 and 12 months.

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About Hollis-Eden Pharmaceuticals

Hollis-Eden Pharmaceuticals is a development-stage company with two product candidates in clinical trials: Apoptone® (HE3235), in the dose-escalation portion of a Phase I/II trial of patients with late-stage prostate cancer, and Triolex®, in a Phase IIa trial in obese type 2 diabetes mellitus patients. Apoptone® and Triolex® represent the lead candidates from Hollis-Eden's small molecule platform based on metabolites or synthetic analogs of endogenous steroid hormones. For more information on Hollis-Eden please visit www.holliseden.com.

This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, the Apoptone® mechanism of action; that PSA levels will remain stable or continue to decline; and expanding subject eligibility criteria to include earlier-stage, chemotherapy-naive patients in a controlled Phase II Apoptone® trial. Any statement included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause Hollis-Eden's actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in the Company's business, including, but not limited to: the ability to complete preclinical and clinical trials successfully an d within specified timelines, if at all; the ability to obtain regulatory approval for TRIOLEX^® (HE3286), APOPTONE^® (HE3235) or any other investigational drug candidate; the Company's future capital needs; the Company's ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual property rights of others; the development of competitive products by other companies; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, Hollis-Eden undertakes no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.

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