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Thursday, 01/31/2008 9:20:36 PM

Thursday, January 31, 2008 9:20:36 PM

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Science Behind SF-1019
SF-1019 has also been shown to function
as a vaccine adjuvant for antigens
of both viral and bacterial origin

SF-1019 comprises the platform technology for what Argyll Biotechnologies believes may lead to a new, world class series of Biological Response Modifiers (BMRs) developed from mammalian serum. Argyll Biotechnologies feels this technology represents a cutting edge scientific breakthrough, utilizing some of the many complex compounds and cells generated by the immune systems of living animals in response to viral, bacterial and other stress challenges. The current research medications for a number of neurological conditions, as derived from SF-1019, have demonstrated their ability to create a wide variety of immune responses by targeting both the innate and adaptive immune systems simultaneously.

The basic technology and mechanism of action of SF-1019 were originally discovered by Argyll Biotechnologies’ principal investigator, Professor Kenneth Willeford, of Mississippi State University. Claims in a key patent application, which encompass the SF-1019 molecule and names Dr. Willeford as an inventor, have recently been allowed and are expected to issue. Additional patent protection has also been applied for concerning the manufacturing processes and chemical variations of SF-1019.

SF-1019, as disclosed and described in Argyll Biotechnologies’ published patent applications, comprises a group of novel lipo-peptides which have no direct antimicrobial activity when screened against a variety of gram positive and gram negative bacteria. Nevertheless, in pre-clinical human studies as well as animal studies, SF-1019 demonstrates an ability to abate microbial pathogenesis as presented in Salmonella typhimurium mouse and Pasteurella multocida avian models while also appearing to abate viral pathogenesis as presented in a canine parvovirus study. SF-1019 has also been shown to function as a vaccine adjuvant for antigens of both viral and bacterial origin. In veterinary clinical field trials, it has been shown to be effective against bovine respiratory disease complex (shipping fever), canine parvo viral enteritis, equine West Nile Viral encephalitis, and equine respiratory disease.

Following an initial infection, the adaptive immune system may take days or weeks to react. However as most organisms are under constant assault from pathogens, the faster-acting innate immune system tends to be the first line of response.

Innate immunity defends against most pathogens by rapid responses coordinated through "innate" receptors that recognize a wide spectrum of conserved pathogenic components. Plants for example and many lower animal species do not possess an adaptive immune system, and rely instead upon their innate immunity. This system, when activated, has a wide array of effector cells and mechanisms, which include several different types of phagocytic cells, which together with the Complement System act to ingest and destroy invading pathogens.

SF-1019, which was developed using enhanced protein-profiling techniques, comprises a series of naturally occurring lipo-peptides extracted from a mammalian source. These peptides have been separated by both filtration and other proprietary selective means.

SF-1019 was initially designed as a wound healing product. However, its hypothesized mechanism of action, as derived from observations arising from both the pre-clinical human studies and animal model trials, indicates that SF-1019 may have a wide range of applications relating to conditions of an inflammatory nature such as Multiple Sclerosis (MS), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Reflex Sympathetic Dystrophy Syndrome (RSD or RSDS) (debilitating pain) and other indications.

In various pre-clinical human studies, performed under either informed consent (EU) or compassionate waiver (U.S.), over 1000 subcutaneous 1.5 ml doses have been administered to over 80 patients, with no major adverse events being reported over a period in excess of 18 months. Treatment with SF-1019 would appear to induce an immunomodulatory cascade, which could explain the therapeutic effects. Patients who were suffering from a range of conditions of the nervous and immune systems, have reported a rapid reduction of their symptoms in as little as 5-6 minutes. Since some of the improvements occur too quickly for known anti-inflammatory pathways, it is possible that SF-1019 possesses neuro restorative properties via a channel blocking process. Moreover, increased levels of cytokine expression were also observed. The immunological profile of patients with inflammatory conditions who have received treatment appear to have had their cytokine profiles convert from a TH-1 to a TH-2 status; in other words, from a hyper-stimulated and pro-inflammatory to a largely anti-inflammatory condition. This would result in the reduction of inflammation mediated tissue damage in patients with such conditions. For information on one such study, go to Recent SF-1019 Study.

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