At what stage is the approval process for SF-1019?
Applications are currently underway with the Food and Drug Administration (FDA) for clinical trial approval of SF-1019 relating to Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Reflex Sympathetic Dystrophy Syndrome, (RSD or RSDS). In Europe, similar applications are also being prepared for the European Medicines Agency (EMEA) for further trials relating to diabetic ulcers and other wound healing.
When will SF-1019 be available?
We are hopeful that SF-1019 may soon be available in some locations. The approval process for SF-1019 has been initiated in both the U.S. and Europe.
Is Immunosyn looking to acquire other products, patents or technologies?
We were established as a marketing and distribution company in order to bring biological and natural remedies that can cause the human immune & healing systems to provide both prophylactic and therapeutic relief from debilitating chronic auto-immune and infectious disease. In this scope we will explore opportunities to license therapies that are sympathetic with this mission.
Is Immunoysn doing any further research & development?
Immunosyn is not a research and development company. Our current licensing agreements call for the owner of the pharmaceuticals which are licensed to us to provide all R & D as well as regulatory approvals.
How is SF-1019 administered? Is it an injection or a pill?
SF-1019 is administered by a medical professional as a subcutaneous (under the skin) injection.
Are clinical trials of SF-1019 currently taking place?
Not at this time. However, Argyll Biotechnologies who is the company that has granted the exclusive rights to market, sell and distribute SF-1019 to Immunosyn and whose responsibility this step is, has initiated the approval process in several countries, and preparations for clinical trials in humans are underway in both the US and Europe for SF-1019. Argyll Biotechnolgies is hopeful that the first in this series of formal clinical trials being planned for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and wound healing will be approved to begin in late 2007 or early 2008.
Who is Argyll Biotechnologies, LLC and how are they related to Immunosyn Corporation?
Argyll Biotechnologies is the owner and developer of the platform technology which we refer to as SF-1019. Argyll Biotechnologies has granted to Immunosyn Corporation the world-wide rights to market, sell and distribute SF-1019 under an exclusive license. Argyll is responsible for its further research, development and clinical testing, obtaining regulatory approval for its sale and distribution. It also will provide product support and is the sole source for the supply of SF-1019 to Immunosyn Corporation.
Argyll Biotechnologies, LLC and Argyll Biotechnologies, LLC’s affiliates including its Business Management Team and Science Team currently own the majority of the outstanding stock and are in a controlling positing over Immunosyn Corporation and therefore have a vested interest in its success.
How and where was SF-1019 developed?
SF-1019 is the platform technology owned by Argyll Biotechnologies, LLC and licensed to Immunosyn Corp. It was developed from extensive research into Biological Response Modifiers (BRMs) undertaken at: Mississippi State University; St George's, University of London (formerly St George's Hospital Medical School); Ohio University; and Methodist Hospital. The first group of BRMs was designated as Immune Cell Potentiating Factors (ICPF) and has been extensively evaluated in a number of veterinary treatments and also animal studies relating to human disease.
