Description

ADS Biotechnology, Ltd. is a pre IND biomedical company developing a novel, first-in-class blood volume expander created by scientists at the University of Toledos College of Medicine. The company's patent protected proprietary technology, termed ADS4203, is a Pegylated Albumin biologic that promises to become the optimADS Biotechnology, Ltd. is a pre IND biomedical company developing a novel, first-in-class blood volume expander created by scientists at the University of Toledos College of Medicine. The company's patent protected proprietary technology, termed ADS4203, is a Pegylated Albumin biologic that promises to become the optimal blood volume expander for the treatment of acute respiratory distress syndrome (ARDS) or any severe medical or trauma condition that triggers capillary leak syndrome (CLS).l blood volume expander for the treatment of acute respiratory distress syndrome (ARDS) or any severe medical or trauma condition that triggers capillary leak syndrome (CLS).

Products / Services

ADS4203 is created through the chemical bonding of human serum albumin (the predominant blood protein) and polyethylene glycol (PEG) an inert, widely-used, and widely-available chemical. In the presence of CLS, ADS4203 will not leak through compromised capillary walls to the extent of currently available products. Upon intravenous administration, ADS4203 works immediately to re-establish blood volume, blood flow and blood pressure. It (1) reduces further leakage of blood proteins and plasma water into surrounding tissue, and (2) reverses CLS, thereby giving the body the critical time it needs to heal its damaged capillary vessel walls and to recover from the underlying insult or injury.

Technology / Differentiation

ADS4203 is protected by three issued U.S. patents centered on the treatment of hypovolemic conditions and the necessary composition to maintain critical protein function, three pending U.S. utility patent applications, one Patent Cooperation Treaty (PCT) application for international patent processing and three international patents. The inventors of ADS4203 have also developed derivative albumin-based products. The development of commercial clinical applications for the ADS4203 product and derivative products will be the ongoing work of the Company.

Market / Customers

CLS, a serious medical condition that has been defined and discussed in the medical literature for decades, is a counter-adaptive response of the body to any severe injury or insult. Clinicians are hampered greatly by CLS due to limited treatment options, all of which are largely ineffective or deleterious. When triggered, CLS compromises the integrity of capillary vessel walls. As a result, there is a markedly increased permeability (i.e. propensity to leak) within the damaged vessel walls, followed by recurrent episodes of hypotension (i.e. low blood pressure). These episodes are characterized by the sudden transient shifting of 10% - 70% of the body's blood proteins and plasma water from the damaged, leaking capillary vessels into surrounding tissues. The body's subsequent response is persistent, dangerously low blood pressure, interstitial edema (i.e. swelling of the surrounding tissues), hypo-perfusion and edema of vital body organs, and a significant decrease in oxygen delivery to critical areas of the body. When left untreated, CLS develops into a deleterious iterative cascade of recurrent episodes of hypotension that can lead to multi-organ dysfunction and failure and, in many cases, death. Mortality rates five years after the diagnosis of CLS have been reported to be as high as 76% . Medical and trauma conditions that trigger CLS include, but are not limited to the following: Acute respiratory distress syndrome (ARDS), poly-trauma (including hemorrhagic shock), traumatic brain injury (TBI), pancreatitis, burns, complex surgical procedures (e.g. open-heart surgery and large organ transplants), and severe sepsis. In the U.S., the combined incidence of these medical and trauma conditions is estimated at greater than 2.7 million cases per year. In the U.S. military, CLS is a leading cause of morbidity and mortality among soldiers injured in battle and/or infected with microbiological pathogens. Current conventional treatment for CLS is the intravenous administration of a blood volume expander. This treatment is largely empirical and generally ineffective. There is presently no commercial blood volume expander available that can safely and effectively treat CLS , creating a clear unmet clinical need.

Competitors / Substitutes / Alternatives

Alternative blood volume expanders currently available include: colloid solutions, crystalloid solutions, and starch and dextran solutions. The new drug development pipeline for alternative CLS therapies includes: newer perflourochemical emulsions and immunomodulatory agents, modified colloids, and artificial hemoglobin-based blood substitutes. It is the Companys expressed opinion that none of the presently available products or new products in development can or will address the clinical indication of capillary leak and ARDS as practically and definitively as ADS4203. To date, all commercially available products have been shown to be ineffective and, to varying degrees, deleterious to patients.

Strategy

ADS Biotechnology Ltd. has a drug development plan that targets ARDS as the first indication for ADS4203. ARDS is a life threatening manifestation of acute lung injury with mortality rates 40-60% 5. It is characterized by the acute onset of diffuse, bilateral pulmonary infiltrates secondary to non-cardiogenic pulmonary edema, refractory hypoxia, and decreased lung compliance. Acute respiratory distress syndrome occurs most frequently in the setting of sepsis, aspiration of gastric contents, trauma, or multiple transfusions. No specific therapy for ARDS exists. Treatment is primarily supportive using a mechanical respirator and supplemental oxygen. Intravenous fluids are given to maintain blood pressure, and in some cases to provide . While these supportive measures may provide short-term benefit, they can also lead to serious problems including fluid overload especially in the lungs (i.e. pulmonary edema) and oxygen toxicity. According to the NHLBI, 150,000 Americans will be diagnosed each year with ARDS.

Funding

Funding Needs ADS is seeking $12 million to pursue the commercial product development of its core product, ADS4203. This round will fund ADS Biotechnology through Phase IIa to demonstrated superiority in humans. This round will be needed over four years with the following use of funds to provide proof of concept in humans: Quality Systems ($400,000) and API Development ($2 million) Pilot Manufacturing ($1.3 million) Toxicology ($750,000) Phase I Clinical Trials a: ($750,000) and b: ($1.25 million) Phase IIa Clinical Trials ($2.5 million) Key Personnel ($3 million) Investor Exit The Companys primary goal is acquisition/sale to a major pharmaceutical company or albumin manufacturer at the conclusion of its Phase IIa trial. A secondary goal would be a sub license and/or partnership agreement with the potential customers. Investors will receive equity in any acquisition, sub license and/or partnership agreement with the potential for equity in any royalties.

Status

ADS Biotechnology is a pre-clinical biopharmaceutical company that is prepared to begin GMP manufacturing for toxicology and early clinical studies upon funding.