FDA Orphan Drug Designated Immunitor V5 Development to be Accelerated
NEW YORK, NY / ACCESSWIRE / December 1, 2020 / KEY CAPITAL CORPORATION (OTC PINK:KCPC) advises that in association with Immunitor Inc, the Company will seek to fast-track further clinical studies and regulatory approval of the FDA Orphan Drug Designated Immunitor V5 as a development priority.
Immunitor V5 has demonstrated unparalleled success in all clinical studies to date for the treatment of liver cancer, which is predominantly hepatocellular carcinoma (HCC). Immunitor studies report that patients taking just one oral Immunitor V5 immunotherapeutic vaccine tablet daily exhibited an industry unprecedented 12-month response and survival rate in 90% of cases. This dramatically exceeds the less than 10% average survival of HCC patients on conventional anticancer drugs.
Current Liver Cancer Situation and Options:
There is urgent need for an effective liver cancer treatment, as its incidence is increasing affecting over 800,000 people annually with a high mortality rate of about 700,000 per year, and treatment options being prohibitively expensive. In most patients, by the time HCC is diagnosed, surgical intervention or liver transplants are often not feasible, and conventional systemic chemotherapies have poor response success and are quite systemically toxic.
None of the currently approved or experimental HCC drugs are free from adverse side effects, nor have they secured significant success in treatment or shrinking tumors. Keytruda for example, aside from its high cost, only has a 10% positive response rate in 12-month HCC treatments.
Immunitor Breakthrough HCC Treatment
As reported in the February 2017 peer-reviewed open access Journal of Hepatocellular Carcinoma, in a recent Immunitor clinical study of 75 patients with late-stage or inoperable HCC; over 90% of patients were responsive to V5 treatment and alive after a median 12 months of follow up - by comparison only about 10% are responsive after one year of treatment with Nexavar.
In an ongoing V5 study (See: ClinicalTrials.gov Identifier: NCT02232490), the high response rates and unprecedented safety experienced in previous V5 studies are being confirmed, as are clinical benefits, namely, improved liver function and tumor marker alphafetoprotein (AFP) decrease. AFP decrease correlates to tumor regression and where levels returned to normal, tumors disappeared. As indicative of the breakthrough potential of V5, all enrolled HCC patients were under palliative care, pronounced incurable, without available treatment options, and/or in terminal disease stage, having a variety of symptoms related to decompensated cirrhosis including ascites, edema, variceal bleeding, portal thrombi, and hepatic encephalopathy. (See: Hepatoma Research, Jan 2020)
Notably, the patented V5 harnesses the immune system by leveraging V5 immunotherapy to elicit a powerful immune response that combats cancer through natural process. V5 does not contain any chemicals, live virus, or any synthetic, engineered, or structured monoclonal antibodies, cytokines, or immune checkpoint inhibitors. V5 is not toxic, has no side effects, and does not cause any cytotoxicity, mutagenicity, teratogenicity, or genotoxicity. In fact, alongside demonstrating positive specific response to HCC, Immunitor V5 appears to also offer added broad-spectrum immunity benefits; however, this aspect needs to be further investigated.
Summary:
Despite the extraordinary and unprecedented success of the V5 liver cancer clinical studies to date, further and more comprehensive studies compliant with US FDA standards are now needed to confirm the Immunitor V5 study results and to progress to formal product approvals.
Company Chairman, Peter Boonen stated, "Immunitor has proven V5 safety, efficacy, and science, and also overcome the challenge of achieving immunotherapeutic benefits directly through the mucosa/microbiome, our primary defense against all disease and infection. I have personally seen extraordinary V5 success in terminal and non-treatable cancer cases that are now in full remission. The sooner that we can achieve FDA approvals, the quicker we will be able to offer the many patients that currently have little to no hope the opportunity of possible positive disease response."
Finally, the financial impact of the potential breakthrough Immunitor V5 immunotherapy oral pill vaccine offers vastly improved dynamics for all treatment stakeholders: the patient, family, carers, employers, insurers, hospitals, and government healthcare and military agencies. With the costs of Immunitor V5 immunotherapy for HCC at around 10% of other immunotherapies and Immunitor V5 treatment having no side effects or requiring hospitalization or complex treatment, the financial burden of HCC can be substantially eased. For example, the USA annual costs for military veterans HCC care, estimated at US$7.2 billion in 2016, could be dramatically reduced.
About Key Capital Corporation: The Company's immediate objective is the further development of the oral pill immunotherapeutics opportunity through its Key Biotec and Immunitor partnering, and particularly advancing the Orphan Drug Designated V5 cancer candidate, along with early focus on disease conditions with unmet needs.
For further information see: https://keybiotec.com and https://keycapitalcorp.com
For all inquiries please contact: Key Capital at +1 (646) 401-0177, or Peter Boonen, Chairman, at peter@keycapitalcorp.com
References:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=457714https://www.keytruda.com/advanced-hepatocellular-liver-cancer/previously-treated-clinical-trials/
https://pubmed.ncbi.nlm.nih.gov/28443252/
https://hrjournal.net/article/view/3315
https://clinicaltrials.gov/ct2/show/NCT02232490?term=immunitor&draw=1&rank=3
https://www.natap.org/2017/HCV/122817_02.htm
Disclaimer: Statements made in this press release that express the Company or management's intentions, plans, beliefs, expectations, or predictions of future events, are forward-looking statements. The words "believe," "expect," "intend," "estimate," "anticipate," "will" and similar expressions are intended to further identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Those statements are based on many assumptions and are subject to many known and unknown risks, uncertainties and other factors that could cause the Company's actual activities, results or performance to differ materially from those anticipated or projected in such forward-looking statements. The Company cannot guarantee future financial results, levels of activity, performance or achievements and investors should not place undue reliance on the Company's forward-looking statements.
SOURCE: Key Capital Corporation
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