Biotherapeutics, Inc. | Date: 2016-11-29
The invention is directed to methods for preventing and/or treating nasal polyps. The invention is further directed to methods for preventing and/or treating rhinosinusitus. The invention is further directed to reducing inflammation of the paranasal sinuses. The invention is further directed to methods for preventing and/or treating nasal polyps and/or rhinosinusitis by administering to a subject suffering from such conditions, or at risk of developing such conditions, novel cellular factor-containing solution compositions (referred to herein as CFS compositions), including novel immediate-release, targeted-release, and sustained-release (SR) cellular factor-containing solution compositions (referred to herein as SR-CFS compositions)
Biotherapeutics, Inc. | Date: 2017-04-06
The invention is directed to methods for treating ocular contusion and blunt injury to the eye and for treating traumatic injury of the optic nerve. The invention is further directed to treating ocular contusion and blunt injury to the eye and for treating traumatic injury of the optic nerve by administering to a subject suffering from such conditions Amnion-derived Cellular Cytokine Solution (ACCS), including novel immediate-release, targeted-release, and sustained-release (SR) ACCS compositions (referred to herein as SR-ACCS compositions) and/or and Amnion-derived Multipotent Progenitor (AMP) cell compositions. Such administration includes intranasal administration of ACCS and/or AMP cells.
Biotherapeutics, Inc. | Date: 2017-04-20
The invention is directed to methods for the treatment of diseases and conditions caused by increased vascular permeability. The invention is also directed to methods for returning vascular permeability that is a symptom of a disease or condition to a homeostatic state. Specifically, the invention is directed to methods for the treatment of diseases and conditions caused by increased vascular permeability or returning vascular permeability that is a symptom of a disease or condition to a homeostatic state by administering to a subject suffering from such diseases and conditions and symptoms novel cellular factor-containing solution compositions (referred to herein as CFS compositions), including novel sustained-release cellular factor-containing solution compositions (referred to herein as SR-CFS compositions).
Biotherapeutics, Inc. | Date: 2017-04-03
The invention is directed to methods for preventing and/or treating optic neuritis. The invention is further directed to reducing inflammation associated with the development of optic neuritis. The invention is further directed to methods for preventing and/or treating optic neuritis and/or inflammation associated with the development of optic neuritis by administering to a subject suffering from such conditions, or at risk of developing such conditions, novel cellular factor-containing solution compositions (referred to herein as CFS compositions), including novel immediate-release, targeted-release, and sustained-release (SR) cellular factor-containing solution compositions (referred to herein as SR-CFS compositions) and/or and Amnion-derived Multipotent Progenitor (AMP) cell compositions.
Biotherapeutics, Inc. | Date: 2017-04-25
The invention is directed to methods for treating nervous system injury and disease, in particular traumatic brain injury and degenerative nervous system disease. Such methods utilize novel compositions, including but not limited to trophic factor-secreting extraembryonic cells (herein referred to as TSE cells), including, but not limited to, amnion-derived multipotent progenitor cells (herein referred to as AMP cells) and conditioned media derived therefrom (herein referred to as amnion-derived cellular cytokine solution or ACCS), each alone or in combination with each other and/or other agents.
Biotherapeutics, Inc. | Date: 2016-10-10
The invention is directed to a novel cell-derived composition having bone growth, regeneration, and repair promoting properties. In particular, the invention is directed to a novel cell-derived composition having bone growth, regeneration, and repair promoting properties termed Amnion-derived Cellular Cytokine Solution-B (ACCS-B). The invention is further directed to the use of this novel composition to promote bone growth and/or regeneration and/or repair.
Biotherapeutics, Inc. | Date: 2017-04-12
The present disclosure relates to methods for treating type 1 diabetes (T1D) using a glucagon receptor blocking agent. More specifically, the present disclosure relates to methods for treating T1D using substantially lower doses of insulin supplementation, or even in the absence of insulin supplementation, using antigen binding and antagonizing proteins, e.g., fully human antibodies that specifically bind to and antagonize the function of the human glucagon receptor.
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 224.66K | Year: 2016
DESCRIPTION provided by applicant Fast Track Insulin remains the primary and often the only treatment for type diabetes mellitus T D However it is associated with chronic iatrogenic hyperinsulinemia secondary hyperlipidemia higher incidence and severity of cardiovascular complications and life threatening hypoglycemia events A higher mortality vs due to cardiovascular complications were reported in insulin treated T D patients versus the general public An effective add on therapy is needed to reduce daily insulin doses and to minimize its complications REMD is a fully human high affinity glucagon receptor GCGR antibody that blocks the hepatic GCGR and reduces hepatic glucose ketone production REMD restores euglycemia in animal models of type diabetes mellitus T D and shows preliminary but promising glucose lowering effect in a few T D mouse models REMD demonstrated a benign safety profile in animals and in healthy volunteers in a first in human study Since the overactive glucagon action is a common finding in both T D and T D a robust GCGR blocker such as REMD represents a promising novel strategy In Phase I of this project the glucose lowering effects of REMD will be thoroughly evaluated in animal models of T D including a chemical streptozotocin induced model in rats and an autoimmune non obese diabetic NOD model in mice both without insulin treatment The animal studies will be directed by Dr Roger Unger at the Touchstone Diabetes Center University of Texas Southwestern Medical Center Dallas TX In Phase II a randomized double blind vehicle controlled day in patient clinical study will be conducted i patients with T D to quantitatively assess the reduction in insulin requirements while maintaining standardized postprandial and postabsorptive glycemic control The study will be directed by Dr Sam Klein Chief Div of Geriatrics andamp Nutritional Sciences at the Washing University School of Medicine St Louis MO The small business REMD Inc provides research materials performs the hormone and metabolite assays and coordinates the overall project management and supportive duties for both Phase I and II of this project REMD is projected to be an add on therapy for T DM to substantially andgt reduce insulin daily doses leading to better glucose control fewer and milder complications and an improved quality of life PUBLIC HEALTH RELEVANCE Fast Track Assessment of the glucagon receptor blocker REMD on insulin requirements in type diabetes The heavy reliance of type diabetic T D patients on multiple daily insulin injections often leads to secondary hyperinsulinemia and increased incidence and severity of cardiovascular events and life threatening hypoglycemia REMD is a fully human glucagon receptor antibody which has demonstrated a benign safety profile in animals and in humans and a robust glucose lowering effect by suppressing hepatic glucose output in various animal models of type diabetes This project plans to evaluate the effects of REMD in correcting hyperglycemia in two animal models of T D streptozotocin induced diabetic rats and Non obese diabetic mice without insulin treatment and to quantitatively assess the clinical efficacy of REMD versus vehicle control in minimizing insulin requirement for standardized glucose control in patients with T D
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 250.00K | Year: 2016
Biotherapeutics Inc BTI is a science based biotech Company specialized in developing novel disruptive nutritionals and therapeutics for diabetes and inflammation BTI has licensed patent applications from Virginia Tech related to novel methods of suppressing inflammation during diabetes including significant IP on the anti diabetic actions of abscisic acid ABA The goal of this project is to develop ABA as a medical food ingredient and validate an effective dose of ABA that improves glycemic control in diabetes Significance Diabetes affects close to million people in the U S and is the seventh leading cause of death worldwide Annual expenses for treating diabetes exceed $ billion per year in the U S alone making it one of the most expensive diseases Under the Orphan Drug Act a medical food is formulated to be consumed enterally for the dietary management of a disease for which distinctive nutritional requirements are established by medical evaluation and its dietary management cannot be achieved by modification of the normal diet alone Diabetic patients suffer from low plasma ABA pools that cannot be recovered through the normal diet Our Product BTI and others have demonstrated that supplementation with ABA is a safe and non toxic method to improve glycemic control in mice rats and humans with an effective dose as low as g kg and no adverse side effects The goal of this SBIR Phase I proposal is to develop ABA as a medical food ingredient for glycemic control This is an innovative and cost effective nutritional intervention for controlling blood glucose levels without requiring patients to significantly alter their current lifestyle or initiate drug regimens with adverse side effects The Specific Aims are to AIM Develop a new GMP compliant and cost effective method of food grade ABA manufacturing Expectations ABA production at $ g AIM Evaluate ABA PK profile bioavailability safety and lowest effective dose for glycemic control Expectations Safe and orally active effective dose of ABA is g kg validated in two species AIM Validate the mechanism of action and cell specificity of dietary ABA in mice Expectations ABA requires LANCL for therapeutic glucose uptake in a cell specific manner The SBIR Phase II will be centered on securing Generally Regarded as Safe GRAS status for ABA performing a human intervention study in patients with metabolic syndrome to validate safety tolerability and efficacy of an ABA formulation for glycemic control ABA containing GlucaBridge will be compared to other commercialized nutritional products for glycemic control such as Glucerna in clinical trials Commercial Application This work will provide an excellent assessment of the feasibility of developing novel branded ABA containing GlucaBridge for glycemic control with product cost estimated at under current alternatives GlucaBridge will disrupt a $ B medical foods and $ B diabetes market by Abscisic acid ABA has demonstrated outstanding efficacy in improving glycemic control but even though its concentration in some fruits is high the amount of ABA available in the normal diet alone is insufficient to provide an effective control of blood glucose levels Given that of adults in the U S have metabolic syndrome obesity pre diabetes or diabetes have low levels of ABA in metabolic pools an ABA containing medical food developed under this project will address the overlying health problems of over million US consumers with a market of $ B annually by
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 756.08K | Year: 2016
DESCRIPTION provided by applicant A research plan is proposed to produce potent human polyclonal antibodies against influenza viruses by immunizing genetically modified bovines with seasonal influenza vaccine in combination with a strong adjuvant and immune stimulator Previous studies have demonstrated that genetically engineered bovines are capable of producing large amounts of human polyclonal antibodies with extremely high titers and neutralization antibody activities against various antigens including influenza viruses following multiple immunizations In this study SAB Biotherapeutics Inc SAB and University of South Dakota intend to expand our earlier proof of concept study to produce a human anti influenza polyclonal antibody product at pilot scale under current Good Manufacturing Practices cGMP using SABandapos s innovative human antibody production platform technology diversitAb tm and evaluate the antibodies in pre clinical studies There are five specific aims in this project o immunize genetically engineered bovines with tetravalent seasonal inactivated influenza virus vaccine to generate fully human polyclonal antibodies against influenza and collect hyperimmune plasma to perform in vitro antibody characterization of anti influenza serum generated in Aim to manufacture purified fully human anti influenza antibody product at pilot scale under cGMP using plasma collected in Aim and conduct a validation study of viral clearance to perform quality control tests for the release of purified anti influenza antibody product and conduct stability testing and to conduct Investigational New Drug IND enabling pre clinical studies including a in vivo efficacy studies using a ferret model and b in vitro human tissue cross reactivity study of manufactured anti influenza product Toxicity and pharmacokinetics studies in non human primates will be performed following these studies although not as a part of this grant Data generated from this grant will enable SAB to prepare and file an IND application for a human Phase clinical trial It is expected that fully human antibodies against influenza viruses produced in Tc bovines will have high potency and can be used to treat immunocompromised individuals who do not produce a response to the seasonal influenza vaccine The success of this project would also provide validation for SABandapos s genetically engineered bovine platform technology as a novel approach to producing safe and potent human antibody therapeutics to treat a wide range of diseases caused by emerging pathogens in the future PUBLIC HEALTH RELEVANCE Genetically modified bovines that express human polyclonal antibodies will be hyperimmunized with four strains of seasonal influenza virus vaccine Antibody titers against influenza viruses will be evaluated using in vitro assays during the immunization process Fully human polyclonal antibodies against influenza viruses will be purified from hyperimmune bovine plasma at pilot scale under current Good Manufacturing Practices and evaluated in Investigational New Drug enabling preclinical studies intended for approval of a therapeutic product for influenza treatment in immunocompromised individuals