Sorrento Announces Positive TRIBECA Registrational Study Results; Immune Therapeutics Announces NAFDAC Approved 90-Day Bridging Trial of Lodonal™ Print E-mail
By Josh Gee   
Monday, 04 May 2015 19:19
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 4, 2015.  
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) is pleased to announce positive results from recently analyzed pharmacokinetic (PK) data from its TRIBECA (TRIal establishing BioEquivalence between Cynviloq™ and Albumin-bound paclitaxel) registrational trial. 
Data analysis suggests that Cynviloq meets the bioequivalence (BE) criteria for both total and unbound paclitaxel. The ongoing safety assessment from treated patients continues to reveal no unexpected adverse events and the safety data is consistent with the toxicity profile reported in the literature with albumin-bound paclitaxel.
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Immune Therapeutics Inc (OTCMKTS: IMUN), through its fully owned subsidiary, TNI Biotech International, announced the dosing of the first patient with Lodonal™ (Once-daily Oral Treatment) for the 90-Day bridging clinical trial of Immune Therapeutics' proprietary patented therapy (Lodonal™) as an adjunct treatment for HIV/AIDS and opportunistic infections.
The Bridging Trial has met all parameters of the Nigerian Trial Clinical Research Health [NTCR] & Nigerian Health Research Ethics Committee [NHREC] as confirmed on their official website and stated below: 89519615
A Bridging study to Evaluate the Effects of LODONAL as an Immune-System Regulating Agent in Subjects in Which their Immune System is Compromised. The primary objective of this clinical trial is to confirm that LODONAL has a beneficial effect on the immune system of patients in Nigeria with a compromised immune system (refer to Inclusion/Exclusion Criteria). This will be determined by: The number of subjects with CD4 count stabilization (less than 10% change from baseline mean values) or 25% increase in CD4 counts on LODONAL compared to observation group from baseline to Days 30, 60 and 90. 2015-03-31
http://nctr.nhrec.net/search.php?search=lodonal&submit=Search
Dr. Abayomi Oni, Principal Investigator and Lead Consultant on this trial at State Hospital Asubiaro, stated "I am excited about the possibility of Low Dose Naltrexone (Lodonal™) being of immense benefit to our local population of patients with HIV/AIDS in Osun State, Nigeria as has been proven with other populations."
AIDS is a chronic, potentially life-threatening condition caused by the human immunodeficiency virus (HIV). By damaging your immune system, HIV interferes with your body's ability to fight the organisms that cause disease. NAFDAC determined that using Lodonal™ as an immune adjunct could provide a tremendous catalyst in enhancing the resistance to the proliferation of HIV/AIDS virus. This 90-Day bridging trial simply provides the verification and legitimization of this precept on this population. Upon completion of this trial, Lodonal™ will be available and could provide positive solutions to millions of HIV/AIDS sufferers.
"With the total population in Africa of 1.111 billion (2013) and the incidence and prevalence of HIV and other non-HIV immune compromised states, Lodonal™, being affordable, well tolerated and efficacious in boosting the immune status of individuals at risk is novel and revolutionary. Early deaths due to opportunistic infections would be reduced thereby increasing the labor force in the continent which is essential to the much-awaited economic boom in Africa!" said Dr. Richards Afonja, MD, of American Hospitals and Resorts.
The bridging trial for Lodonal™ is a single center 90-Day, double-blind, placebo-controlled trial. The trial has enrolled over 200 patients consisting of a one a day oral treatment with Lodonal™ or placebo, followed by a 60-day open label extension in which all participants will receive Lodonal™. The superiority of Lodonal™ vs. placebo during the double blind period will be evaluated in terms CD4 count (primary endpoint), while key secondary endpoints include the reduction in the number of opportunist infections and improvements in the quality of life measures.
"The start of this bridging trial for HIV/AIDS is marking the accomplishment of a critical milestone for Immune Therapeutics," said Noreen Griffin, CEO of Immune Therapeutics. "We are grateful for the opportunity to launch Lodonal™ in Nigeria via this trial, as well as the support we have received from the medical community in Nigeria."
There's no cure for HIV/AIDS, but there are medications that can dramatically slow disease progression. These drugs have reduced AIDS deaths in many developed nations. But HIV/AIDS continues to decimate populations worldwide. It is such a devastating health challenge that the US Department of State through its PEPFAR [Presidential Emergency Program for AIDS Recovery] program provides emergency assistance for more than 21 partners, one of which is Nigeria. We believe LDN could be an answer; LDN is safe, easy to administer and affordable.
President & CEO GB Pharma Holdings, Dr. Gloria B. Herndon, said " Nigeria has once again assumed its leadership position by undertaking a bridging trial that will allow Lodonal™ to be available to its population and ultimately the rest of Africa. This will revolutionize the concept of health security in Africa by providing an immune booster that offers solutions that are non evasive and reactive. After my forty-five [45] years experience in Africa, this initiative has the potential of being the most far reaching and impactful I have yet to witness.
Also Monday:
 
Affimed N.V. (Nasdaq:AFMD), a clinical-stage biopharmaceutical company developing highly targeted cancer immunotherapies, today announced that it filed a registration statement on Form F-1/A with the Securities and Exchange Commission. 
 
Air Methods Corporation (Nasdaq:AIRM), the global leader in air medical transportation, announced today that it is entering into a preferred provider relationship with Bayfront Health and its Bayflite air medical transport program.
Air Methods Corporation (Nasdaq:AIRM), the global leader in air medical transportation, announced today that it is entering into a preferred provider relationship with Bayfront Health and its Bayflite air medical transport program.
American CareSource Holdings, Inc. (Nasdaq:ANCI), operator of urgent and primary care centers and a national network of ancillary health care providers, announced today the engagement of urgent care executive consultant, Norman Winland.
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and Circulating Tumor Cells (CTCs), today announced that the Company will issue its financial results for the first quarter of 2015 on Tuesday, May 12, 2015, after the close of the market, and will hold a conference call on this day at 4:30 p.m. ET to discuss the financial results and provide a company update.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that it will release First Quarter financial results after market close on Monday, May 11, 2015. 
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that it will report financial results for the first quarter ended March 31, 2015, on Monday, May 11, 2015, before the market opens. 
CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that it has reached an agreement with the FDA on the Company's previously submitted Phase 3 protocol synopsis for PRO 140, the Company's novel self-injectable antibody for the treatment of HIV, and submitted the full Phase 3 protocol to the FDA today. 
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, announced that it will release its financial results for the first quarter of 2015 after market close on Tuesday, May 12, 2015.
Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases, today announced that it will report first quarter 2015 financial results before the NASDAQ Market opens on Monday, May 11, 2015. 
Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases, today announced that it will report first quarter 2015 financial results before the NASDAQ Market opens on Monday, May 11, 2015.
Macrocure Ltd. (Nasdaq:MCUR), a clinical stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, announced today that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2014 with the U.S. Securities and Exchange Commission (the "SEC").
SANUWAVE Health, Inc. (OTCQB:SNWV) announced today that the Company will release financial results for the first quarter ended March 31, 2015, after the markets close on May 6, 2015.
TG Therapeutics, Inc. (Nasdaq:TGTX) today announced its financial results for the first quarter ended March 31, 2015 and recent company developments.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that Paul Rubin, the Company's Senior Vice President, Research and Development, and Chief Medical Officer, is scheduled to present at the Credit Suisse Antibody Day on May 6, 2015 at 8:35 a.m. Eastern time.
SANUWAVE Health, Inc. (OTCQB:SNWV) announced today that the Company will release financial results for the first quarter ended March 31, 2015, after the markets close on May 6, 2015.



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