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
August 23, 2016
Date of Report (Date of earliest event reported)
Immune Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Florida | 000-54933 | 59-3226705 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No. |
| 37 North Orange Ave, Suite 607, Orlando, FL | 32801 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code 888-613-8802
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):
| [ ] | Written communications pursuant to Rule 425 under 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 August 23, 2016, the Company issued a press release in the form attached hereto as Exhibit 99.1 related to funding for a clinical trial in Malawi.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. The following exhibits are filed herewith.
| Exhibit No. | Description | |
| 99.1 | Press Release |
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.
| IMMUNE THERAPEUTICS, INC. | ||
| Date: August 23, 2016 | By: | /s/ Noreen Griffin |
| Noreen Griffin, CEO | ||
IMMUNE THERAPEUTICS, INC., THROUGH ITS WHOLLY OWNED
SUBSIDIARY TNI BIOTECH INTERNATIONAL, LTD.,
INITIATES CLINICAL TRIAL IN MALAWI WITH LDN FOR THE
PREVENTION OF CERVICAL CANCER
ORLANDO, FL— Immune Therapeutics, Inc. (OTCQB-IMUN) (“IMUN”), headquartered in Orlando, Florida, is a clinical-stage biopharmaceutical company involved in the commercialization, manufacturing, distribution and marketing of its novel immunotherapies to combat chronic, life-threatening diseases through the activation and modulation of the body’s immune system.
IMUN, in conjunction with the College of Medicine Malawi, has initiated a clinical study with LDN for the prevention of cervical cancer. This is an open-label, multicenter study designed to determine the safety and acceptability of a single-visit approach to cervical cancer prevention in patients. Using a single-visit approach to prevent cervical cancer, women will be examined through visual inspection of the cervix with acetic acid wash (VIA) and, if tests results are positive, patients will be offered immediate cryotherapy of the precancerous lesion. The secondary objectives are to determine life extension, to improve the immune system of immune comprised patients by starting treatment with LDN.
The Brewer Foundation in partnership with IMUN arranged both the funding for the trial and the donation of the Wallach LL100 Cryosurgical system necessary to run the trial and treat patients.
“The joint goal of this ever-important initiative is to empower the people of Malawi and to provide affordable health solutions to those most vulnerable. With this trial, we, with IMUN and its subsidiaries, hope to combat cervical cancer and immediately start saving lives in our ongoing initiative to improve global health,” stated His Excellency, Ambassador Jack Brewer, Founder and Executive Director of JBF Worldwide.
Noreen Griffin, Chief Executive Officer of IMUN, said “With the increase in the number of patients in Africa suffering from cancer, the need for affordable non-toxic therapies becomes more important every day. We, with our partners GB Pharma and The Jack Brewer Foundation, intend to be part of finding a solution.”
Dr. Frank Taulo, the head of the OBGYN Department for Queen Elizabeth Central Hospital in Blantyre and Principal Investigator of the trial, explained, “Since the beginning of the cervical cancer prevention programme in Malawi, strides have been made regarding scaling up of the screening services and premalignant lesions treatment using cryotherapy. One of the biggest challenges has been the inadequate cryotherapy medical device. The timely donation of 10 cryotherapy guns has alleviated tremendously this anomaly. Now several centers are able to treat these lesions.”
About IMUN
IMUN is a biotechnology company working to combat chronic, life-threatening diseases through the activation and modulation of the body’s immune system using its patented immunotherapy. Its products and immunotherapy technologies are designed to harness the power of the immune system to improve the treatment of cancer, infections such as HIV/AIDS, chronic inflammatory diseases, and autoimmune diseases.
IMUN’s proprietary technology, therapies and patents include the treatment of a wide range of cancers. Its most advanced clinical programs involve immunotherapy with met-enkephalin (MENK) (sometimes referred to as opioid growth factor) and its LDN product or LodonalTM, which have been shown to stimulate the immune system even in patients with advanced cancer.
Forward Looking Statements
This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to the possibility that some or all of the matters and transactions considered by IMUN and its subsidiaries may not proceed as contemplated, and by all other matters specified in IMUN’s filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. IMUN and its subsidiaries do not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in IMUN’s filings with the Securities and Exchange Commission, including its recent periodic reports.
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