Biotech Values

[bladerunner1717]

re: IMUN

I'm no expert, but this sounds fishy to me (Readers here will probably get a kick out of this. I especially like the part about the Dominican Republic.):






GlobeNewswire•last month
Immune Therapeutics Clears Critical Regulatory Hurdle for Lodonal in Kenya
ORLANDO, Fla., March 17, 2017-- Immune Therapeutics, Inc., a clinical-stage biopharmaceutical company developing therapies for a range of conditions using Lodonal™, its proprietary formulation of lower-dose ...


GlobeNewswire•last month
Immune Therapeutics, Inc. Further Strengthens Balance Sheet as it Prepares for Commercialization
Company Redeems Nearly All Outstanding Convertible Debentures Replaces Nearly $650,000 of Long-Term Debt with Financing on Significantly Better Terms from a Strategic Long-Term Institutional Investor Company’ ...


Accesswire•2 months ago
Immune Therapeutics Signs Distribution MOU for Lodonal in Kenya; Company Plans to Open Kenya for Lodonal in 2017
ORLANDO, FL / ACCESSWIRE / March 8, 2017 / Immune Therapeutics, Inc. (OTCQB: IMUN), a clinical-stage pharmaceutical company developing novel, non-toxic affordable therapies to treat immuno-inflammatory ...


GlobeNewswire•3 months ago
IMMUNE THERAPEUTICS STRENGTHENS BALANCE SHEET; Reiterates Outlook for Positive Cash Flow by Mid Year
ORLANDO, Fla., Feb. 09, 2017-- Immune Therapeutics, Inc., a clinical-stage company developing novel therapies for the treatment of immuno-inflammatory diseases and cancer, today announced it has further ...


GlobeNewswire•3 months ago
Immune Therapeutics Clears Critical Certification Milestone
Immune Therapeutics Receives Approval for Lodonal™ from the Dominican Republic’ s Ministry of Health and Social Assistance. ORLANDO, Fla., Feb. 02, 2017-- Immune Therapeutics, Inc., a global specialty ...



GlobeNewswire•3 months ago
UPDATE -- Immune Therapeutics Issues Special Letter to Shareholders
Company Expects to Report Initial Revenues in First Half of 2017 and Achieve Profitability by Year-End. Company to Host Investor Conference Call to Discuss Positive Developments. ORLANDO, Fla., Jan. 30, ...


37 North Orange Avenue
Suite 607
Orlando, FL 32801
United States
888-613-8802
http://www.immunetherapeutics.comSector:
Industry:
Full Time Employees: 5
Immune Therapeutics, Inc. focuses on the development and commercialization of therapeutic treatments for cancer, HIV/AIDS and autoimmune diseases, and immune disorders in the United States. The company develops IRT-101, an active immunotherapy systemic administration of methionine-enkephalin that works by stimulating and/or regulating a patient?s immune system against infectious diseases, autoimmune diseases, immune disorders, and tumor cells. It also develops IRT-103, an immunotherapy for the treatment of various autoimmune diseases or immune disorders, such as Crohn's disease and multiple sclerosis; HIV/AIDS; and chemotherapy, radiation treatment, or surgery. The company was formerly known as TNI BioTech, Inc. and changed its name to Immune Therapeutics, Inc. in December 2014. Immune Therapeutics, Inc. is headquartered in Orlando, Florida.
More about Immune Therapeutics, Inc.



Immune Therapeutics, Inc. Files Lodonal New Drug Application in Kenya

GlobeNewswire•April 25, 2017Comment
ORLANDO, Fla., April 25, 2017 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (IMUN), a clinical-stage biopharmaceutical company developing therapies for a range of conditions using LodonalTM its proprietary formulation of lower-dose naltrexone, today announced it has submitted its New Drug Application (NDA) to the Pharmacy and Poison Board (PPB) in Kenya for Lodonal for the treatment of patients with HIV and cancer, both as a standalone treatment as well as an adjunct treatment, and as an immunomodulator.

“This NDA submission initiates the process we believe will result in broad access to this our therapy for those suffering from immune deficiency disease and cancer,” said Noreen Griffin, Chief Executive Officer of Immune Therapeutics. “We recognize the difficulty the immune-comprised community has had in obtaining affordable non-toxic therapies and look forward to working closely with the PPB as they review our application.”

A full preclinical and clinical study program supports the filing including: four clinical efficacy trials involving more than 500 HIV/AIDS patients, and one clinical trial with 89 patients for cancer and over 1,200 patients with autoimmune disease. The clinical data showed that Lodonal could improve CD4 count, decrease viral load and reduce the number of opportunistic infections in patients suffering from comprised immune systems.

Omaera Pharmaceuticals, Ltd and GB Pharma Holding supported this filing. “Without their support, the fast track of this process would not have been possible,” noted Griffin. The PPB had a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. “The application was accepted and the company has received an application number. From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. The approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recently announced distribution agreement,” concluded Griffin. The Company plans to reach commercialization for Lodonal in Kenya in 2017.

“We look forward to a smooth regulatory process for Lodonal in Kenya. We have significant experience with Kenya’s PPB and have meetings planned with the Ministry of Health before the end of the month,” notes Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings of Washington, DC.

About Immune Therapeutics, Inc.

Immune Therapeutics, Inc. (IMUN) is a clinical-stage biopharmaceutical company developing its proprietary version of lower-dose naltrexone Lodonal as standalone and conjunctive therapy in patients with a wide variety of conditions including HIV/AIDS, autoimmune diseases, cancer, neurodegenerative conditions and other inflammatory conditions. Lodonal is a novel compound with a unique mechanism of action and has clinical data on over 400 patients in several clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint.


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