Aristea Translational Medicine Corporation
Committed to Scientifically Sound Medical Reseaerch
Aristea Translational Medicine Corporation
Committed to Scientifically Sound Medical Reseaerch
About Aristea
The Challenge Posed by Human Errors:
Unnecessary Drug Development Failures
Sci. Transl. Med. 2, 61rv6 (2010).
Aristea Has Researched Drug Developments to Insure Successes in Drug Developments
The AristeaTM Responds to Neurodegeneration
Aristea Translational Medicine Corp.
Developing PhenT
for
Treatment of Alzheimer's Disease and Traumatic Brain Injury.
A
Market Disruption
Recent research into traumatic brain injury (TBI and Alzheimer’s disease (AD) supports the use of PhenT as a treatment effective controlling symptomatology, suppressing amyloid accumulation, controlling neuroinflammation and protecting neurons from dysfunction and death due to the presence of TBI and AD neuropathology's. Aristea Translational Medicine Corp. using its new drug formulation of PhenT, proposes to mitigate symptoms, neuropathology's, and the neuronal losses in AD and TBI leading to cognitive and behavioral disabilities. In addition PhenT, because of its abilities to inhibit the synthesis of amyloid precursor and ABeta.proteins, offers a unique opportunity to prevent amyloid accumulation in AD patient brains, without resorting to the use of antibodies against amyloid. PhenT promises to disrupt the emerging anti-amyloid marketplace with its dosing, safety, tolerance and economic advantages over currently approved and about to be approved amyloid antibody drugs.
Phenserine’s Market Disruption
Sheldon Gilmore, during his 1971 to 1986 tenure as President of Pfizer Pharmaceuticals, became renowned for his innovative marketing strategies. He ascribed Pfizer’s rise to it not being the first with a drug on the market. The first drug makes the market, the second drug can be positioned to usurp the market. Phenserine presents that opportunity for the current market being created by FDA approval of Biogen’s Aduhelm or aducanumab. As Nature featured on November 15, 2021 and March 9, 2022, other pharmas’ antibodies to amyloid are anticipating FDA approval for wide use in persons genetically disposed to Alzheimer’s disease (AD) and with early or established AD.
Phenserine is uniquely positioned to compete in this market with its properties promising reduction of brain amyloid accumulation by inhibition of Amyloid Precursor Protein synthesis and its product ABeta Protein, the source of brain amyloid.
Administered orally in a new extended release formulation and already shown safe in 645 patients treated for up to one year, phenserine avoids the costs, inconvenience and risks associated with amyloid antibodies: areas of brain swelling, small brain bleeding, headache, falls, confusion, dizziness and nausea, the need for regular brain imaging studies to monitor onsets of abnormalities and administration of treatment at a medical infusion site. Phenserine, avoiding these risks and inconveniences, can provide the safer “option” for patients desired by Dr. Maria Carillo, who sets the strategic vision for the Alzheimer’s Association.
In addition, phenserine is prepared for confirming studies of benefits for AD patients and Traumatic Brain Injury (TBI) patients. In AD phenserine has shown symptomatic benefits comparable to those experienced with the cholinesterase inhibiting drugs prescribed worldwide. In five recently competed animal models, phenserine has shown consistent anatomical and neurochemical biomarker evidence of protecting neurons from death in the presence of AD and TBI brain damage.
Aristea offers the pharmaceutical industry an opportunity to dominate in AD and TBI markets by 1) controlling symptoms in AD, 2) controlling amyloid safely, economically, and conveniently in AD and 3) controlling neuroinflammation in AD and TBE, and 4) preserving neuronal function in AD and TBI thereby modifying the disease course in these conditions
. In Nature Reviews Neurology, the 2020 Delphi Consensus Group, led by Clive Ballard, identified phenserine as “an exciting prospect” for “disease modifying actions” in AD.
For more information contact: Robert E. Becker M.D., C.M., M.A. President Aristea Translational Medicine Corporation 3435 Cedar Drive Park City, UT 84098 435-647-6233 rebecker@AristeaTM.com
PhenT
PhenT has been shown able to block cell dysfunction and death in cultured cells and in five animal models of head trauma, stroke, Alzheimer’s disease (AD) and nerve gas toxicity. It has shown efficacy symptomatically in AD patients and in suppressing the proteins that lead to amyloid deposition in AD
(-)-Phenserine was first synthesized in 1916 and then identified by Nigel Greig at the National Institute on Aging (NIA) and colleagues in the 1990’s as a cholinesterase inhibitor with potential utility in AD. Subsequently amyloid precursor protein inhibitory properties were also identified.
Under license from the NIA, Axonxy pursued a rapid progression of studies into Phase III where inadequate understanding and appreciation of the drug’s metabolism and pharmacokinetics led to repeated failures to demonstrate efficacy. With others, we at the NIA and Aristea Translational Medicine Corp. modified an ongoing Axonxy protocol and demonstrated efficacy in patients with AD supporting the role of investigator error in the earlier failures.1
Encouraged by the evidence of possible efficacy in symptomatic AD and the APP synthesis inhibition that lowers Aβ42 in animals and humans, we first explored and then, following study of the issues, having identified problems with current understanding of the cascade and timing of pathologies in AD, we abandoned a development of (-)-phenserine for a frontal assault on AD. Observing the similarity of pathologies present in AD and the often clinically reported head injury concussions preceding the onset of clinical AD, we explored (-)-phenserine’s pharmacology for possible utility in both AD and concussion/TBI.
Currently we have preclinical evidence supporting its utility against concussion and more severe TBI. Specifically we have found inflammation; oxidative stress; glutamate toxicity; impaired neurogenesis; cholinergic cell loss in the Nucleus Basalis of Meynert, and anoxic cell death, each prominent features in concussion/TBI, responsive to -phenserine. Phenserine countered weight-drop induced brain pathologies under double-blind, placebo-controlled study conditions, showing preservation of neurons, reduced selective pathological intensities, and replications of preserved cognitive performances in Y-Maze and Novel Object Recognition.
Axonyx Corporation initially developed (-) phenserine for AD. This development was based on the acetylcholinesterase (AChE) inhibitory abilities of (-)-phenserine and the evidence of pathological brain changes found some 20 years before the onset of dementia. Degeneration of this system of cholinergic neurons in the Nucleus Basalis of Meynert is one of the earliest observable changes occurring during the course of Alzheimer's disease, with the degree being directly correlated with the severity of memory impairment. Damage to the cholinergic neurons in the Nucleus Basalis of Meynert also occurs during some concussions and TBIs.
The Axonyx sponsored development of (-)-phenserine was abruptly terminated when Axonyx found itself unable to provide evidence of efficacy in AD in a series of large Phase II and III clinical trials. As part of the Axonyx abandonment a group of investigators, of which Nigel Greig Ph.D. and Robert Becker M.D.,C.M. were members, reorganized an ongoing Axonyx trial and demonstrated evidence of efficacy against symptomatic losses in AD. In a project to develop phenserine for its potential to counter the synthesis of APP and accumulations of Aβ42-amyloid, then considered a major pathological cause of the progression into clinical dementia by the Hardy hypothesis of AD. Investigation into this potential application led to two papers summarizing reasons why we, as investigators, found current drugs directed against Aβ42-amyloid destined to be unsuccessful due to lack of understanding of the cascade and timing of pathologies leading to clinical AD. Consequently we abandoned a frontal assault against AD, sought out possible flanking maneuvers, which with shared pathologies and links to the development of AD could provide possible insights into the unfolding of pathologies in AD and into the pharmacological properties of phenserine that might have utility against other neurodegenerations. The ensuing exploration of (-)-phenserine pharmacology resulted in preclinical evidence supporting its utility against concussion and otherTBIs They also identified the need for PhenT, an extended, controlled release formulation that provides drug concentration in the therapeutic range and thereby overcomes that cause of earlier clinical failures of phenserine. With an elimination half life of one hour, immediate release dosing cannot sustain the required brain therapeutic drug effects in brain over the require 24 hours..
Aristea
Company Background
Aristea Translational Medicine Corp. is a Utah small business. Since its incorporation in 2000, with others located at the National Institute on Aging and at US and UK universities, Aristea has investigated the sources of failures in therapeutic drug developments and methods for overcoming unnecessary failures. Beginning in 2010, with investigators at National Institute on Aging, NIH, Aristea turned its expertise in drug development to clinical pharmacological research that has led to PhenT and its proposed applications preventing cell death. In head injury and Alzheimer’s disease uncontrolled programmed cell death leads to irreversible damage, disabilities, and the death of some patients. Aristea has patents and patents pending for each application. Currently, with university collaborators at University of Southern California USA and at University of Exeter in the United Kingdom, a $4,000,000 five year National Institute of Aging grant is supporting clinical trials of PhenT in Alzheimer’s disease. It is anticipated that in the US government 2022-2023 fiscal year a second National Institute of Aging grant of more than $2,500,000 will be awarded supporting clinical trials of PhenT in Alzheimer’s disease.
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