CalicGenix

We believe in a future without Alzheimer's.

That the millions of baby boomers in this world deserve a chance at a future that includes their cherished memories.

Nearly every 71 seconds, someone new in the United States develops Alzheimer’s disease. By the year 2050 this rate is expected to accelerate to every 33 seconds.
-2012 Alzheimer’s disease Facts and Figures

We won’t stop until we’re done.

About Us

CalciGenix is a biotechnology company dedicated to the discovery, development and commercialization of novel technologies to address neurological and neurodegenerative diseases and other age-related health challenges including memory loss and decreases in overall cognitive functioning. The company’s research focuses on addressing the consequences of impaired calcium homeostasis – the imbalance of calcium ions commonly theorized to be implicated in several neurological diseases such as Alzheimer’s disease (AD) and multiple sclerosis (MS). CalciGenix has developed the first known use of the orally available, jellyfish-derived, calcium-binding protein CG-1231, which is being studied in humans for potentially protecting brain cells against neuronal degeneration and cognitive dysfunction.



Research

CalciGenix researches, develops and plans to market therapeutic compounds for the treatment of neurodegenerative disorders, such as Alzheimer’s disease and Multiple Sclerosis.

Learn about Neuroprotection »

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Neuroprotection

Experiments with CG-1231 also indicated a strong neuroprotective benefit in animal models of ischemia. Research results demonstrate CG-1231 as a potential effective neuroprotective protein and data were presented at the annual conferences of The Society for Neuroscience starting in 2006. Annual presentations have been made since. Further studies proved CG-1231 protective in aged animal models and time-course measurements and mode of action studies were also completed.

Dose dependent neuroprotective benefits have been observed in rodent models in both pre- and post-ischemia studies. Results demonstrate that IL-10 expression, as measured by mRNA levels, does indeed increase and correlates with time of CG-1231 infusion in animal models, contributing to the anti-inflammatory effects of the protein and serving to explain the mechanism of action and the beneficial effects observed in our human clinical trial with MS patients.

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Multiple Sclerosis

MS Hope Trial participants showed improvements in a number of different measures of MS quality of life. Greater improvement was seen in those participants who were not in remission or were not taking an MS-specific Disease Modifying Drug prior to entering the MS Hope Trial. These results suggest a potential relationship between CG-1231 and improvements in the quality of life for individuals with Multiple Sclerosis.

At CalciGenix, we believe in a future without Alzheimer's.

We believe that the millions of baby boomers in this world deserve a chance at a future that includes their cherished memories.

Learn about our cognitive studies »

Our mission is to develop and market the perfect therapeutic compound for the treatment of neurodegenerative disorders.

CG-1231 and anti-inflammatory connection »

We won’t stop until we’re done.

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Cognitive Studies

The Madison Memory Study (Underwood, Sivesind, Gabourie, & Lerner, 2011) demonstrated the beneficial effects of CG-1231 (10 mg, daily, oral) on cognitive functioning in older adults. The study findings were presented at the June, 2011 Alzheimer’s Association International Conference in Paris, France. A total of 218 adults with self-reported memory concerns, aged 40 to 91 years, were enrolled in the study and randomly assigned to receive either a daily dose of CG-1231 or a placebo. Participants receiving the treatment not only tolerated the oral dosage well, but they also demonstrated a significant improvement in scores that measure executive functioning, learning and short-term memory. Cognitive testing was performed with the Cogstate computerized assessment tool.

Canine studies have been performed in aged beagles with some degree of cognitive impairment suggesting that CG-1231 when compared to placebo has beneficial effects evidenced in improved learning (assessed in discrimination learning task) and in attention (assessed in the visual search task) as a function of dose (CanCog Technologies, 2010). Also, CG-1231 was compared to Anipryl (l-deprenyl) demonstrating, in general, further evidence that CG-1231 can have cognitively beneficial effects by showing significantly improved performance over positive control on both discrimination learning and on the attention task (CanCog Technologies, 2010). The canine data suggest a potential application of the protein for the treatment of Canine Cognitive Dysfunction Syndrome (CDS)(Milgram and Underwood, 2011).

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Anti-inflammatory Connection

Anti-inflammatory cytokines are increased following infusion of CG-1231 in rodent brains. IL-10 mRNA was elevated in brain slices as early as one hour post-infusion in rodent brains (Detert et al., 2011). IL-10 is an anti-inflammatory cytokine and has been shown to be increased following administration of a Ca2+-channel blocker (Szabo et al., 1997). Preconditioning increases the production of IL-10 (Zhao et al., 2010), and IL-10 is associated with neuroprotection (Dietrich et al., 1999; Gerard et al., 1993). Inflammation is a known contributor to the neurodegenerative disease process in AD and as an immunoregulatory cytokine, IL-10 plays a crucial role in inflammatory and immune reactions. This multifunctional protein demonstrates both anti-inflammatory and immunosuppressive activities in immune cell functions. IL-10 has been the focus of ongoing investigations into its potentially beneficial effects in autoimmune diseases such as multiple sclerosis and fibromyalgia.

“The defining disease of the boomer generation may well be Alzheimer’s.”

– AARP, March 2012

Compound CG1231Learn More
Compound CG1231

CalciGenix researches, develops and plans to market therapeutic compounds for the treatment of neurodegenerative disorders, such as Alzheimer’s disease and Multiple Sclerosis.

New therapeutics will be based on the calcium-binding protein compound, CG1231.

Calcium-binding proteins are important in the protection of certain cellular populations and decrease over the course of aging or disease progression. CG1231 acts in a protective manner similar to proteins that are depleted in humans with these diseases of aging.

Learn about CG-1231′s safety »

Research and development work was conducted in university laboratories in addition to partner facilities to fully develop the therapeutic applications of this technology.

A recently concluded six-month double-blind/placebo-controlled clinical trial featuring 232 MS patients has demonstrated the potential effectiveness of CG-1231 compound as an MS therapeutic based upon improvements seen in several quality of life measures.  Additionally specific cognitive benefits were observed in these MS study participants.

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Compound CG-1231

It was first proposed more than 25 years ago that altered calcium regulation might play a role in normal brain aging, and in the development of Alzheimer’s disease and dementia (Khachaturian, 1987; Thibault, Gant & Landfield, 2007; Green & LaFerla, 2008). The past decades of research have resulted in a solid body of evidence linking calcium and neuronal cell health (Stutzman, 2007; Mattson, 2007). Given that the dysfunction and death of brain cells are hallmarks of AD, it is understandable that scientists have postulated that calcium dysregulation may be a significant factor in the development of AD and other neurological diseases. Scientific data to support this idea has expanded significantly because of its potential for addressing the unmet clinical need for therapeutic intervention.

CalciGenix’s platform technology (CG-1231) is the calcium-binding protein apoaequorin. In all mammals, calcium-binding proteins are important in the protection of cellular populations against toxic calcium overload, especially brain and nerve cells. These calcium-binding proteins decrease in number over the course of aging or disease progression. The loss of this calcium-management component of our nervous system is also implicated in disorders including pain, neuropathy, neuralgia, migraine headache, depressive illness, seizure disorders and generalized cognitive dysfunction seen in aging, traumatic brain injury, post-exposure to heavy metals, environmental toxins and anesthesia. Disruptions in calcium management related to the immune system may have a role in autoimmunity including multiple sclerosis. Apoptotic cascades in stroke and after traumatic brain injury also involve increased levels of intracellular calcium.

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Safety

An evaluation of the potential subchronic toxicity of CG-1231 was conducted in rodents over 90 days with no mortalities during the course of this study. There were no clinical or ophthalmological signs, changes in body weight, food consumption, food efficiency, clinical pathology or histopathological changes attributable to administration of CG-1231. Under the conditions of the study, and based on the toxicological endpoints evaluated, the no-adverse-effect level (NOAEL) for CG-1231 administered orally over 90 days was 667 mg/kg/day, the highest dose tested, for male and female Sprague-Dawley rats (Product Safety Labs, 2012; Moran et al. 2013).

CalciGenix is focused on the discovery, development and commercialization of novel medicines to treat the diseases of aging.

CalciGenix is set apart.

The company’s therapeutic products focus on alleviating the consequences of impaired calcium homeostasis – the imbalance of calcium ions commonly thought to be related to neurodegenerative diseases such as Alzheimer’s and Parkinson’s.

CalciGenix is set apart by its cutting-edge applications of the calcium-binding protein CG1231…breaking new ground in the fight against neurodegenerative disease.

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CG1231 was originally discovered in jellyfish - an organism with one of the simplest nervous systems.

Market

CalciGenix is pursuing novel therapeutics for the treatment of the diseases of aging.

The company’s technology has led to patent filings for applications of the calcium-binding protein CG1231.

While CG1231 has been commonly used in laboratory research for almost fifty years, it had never been used in any therapeutic manner before CalciGenix’s research began.

CG1231 is unique in that it is from a family of molecules that are called calcium-binding proteins. Calcium-binding proteins are known to deplete in the aging process.

CalciGenix sets itself apart through its introduction of CG1231 to help the restoration of calcium homeostasis in the human body.

Research has take place both within private and partnering academic laboratories, and other centers of excellence.

The company’s interests are in calcium metabolism and homeostasis throughout human physiology. The imbalance of calcium ions in sensitive tissues and structures is a common malady in the aging process and is well documented in several age-related diseases.

Research efforts are underway to understand these mechanisms of disease in addition to developing novel treatment for these conditions.

Learn about Multiple Sclerosis »

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Multiple Sclerosis

The medications currently available to slow down the progression of MS are typically taken on a long-term basis and include interferons (Avonex, Tetseron or Rebif), glatiramer acetate (Copaxone), mitoxantrone (Novantrone), natalizumab (Tysabri), fingolimod (Gilenya), methotrexate, azathioprine (Imuran), intravenous IG, and cyclophosphamide (Cytoxan). According to the National MS Society, data from the most recent annual reports of the leading MS drug companies, including Biogen Idec Inc., Merck Serono S.A., Teva Pharmaceuticals Industries Ltd. and Bayer Schering Pharma AG, report that the worldwide sales of drugs to treat MS will exceed $15.0 billion in 2015

Focused on the discovery, development and commercialization of novel medicines to treat the diseases of aging.

CalciGenix’s technology offers an attractive and proprietary approach as an FDA approvable drug with multiple potential pharmaceutical applications.

Investors

The technology behind CG-1231 is well protected with global patents.  The compound has been proven safe in animal studies as well as in a large population of consumers. The protein itself can be produced at a commercial scale, is safe and non-allergenic and available orally with no known harmful side effects.  The identified protein has the potential to address many large market needs with applications in multiple pharmaceutical markets.

Through a truly unique proprietary technology platform, CalciGenix has developed CG-1231 for the treatment of Alzheimer’s disease and multiple sclerosis along with potentially several other neurodegenerative conditions in which calcium regulation has been disrupted.  Because there are no known adverse reactions with other drug therapies, in addition to a stand-alone therapy, it is also plausible that our technology may be used to enhance the cognitive benefits of already existing, or soon to be approved pharmaceutical compounds.

There are large and unmet medical needs for effective therapeutics for these conditions and this protein has the opportunity to meet those needs offering great value to patient and shareholder alike.

Press Releases

In the news

CalciGenix is committed to improving the quality of life, with a special focus on neurological health issues, for people worldwide. Through a truly unique proprietary technology platform, CalciGenix has developed a potentially therapeutic protein for the treatment of Alzheimer’s disease and multiple sclerosis along with several other neurodegenerative conditions in which calcium regulation has been disrupted. On the surface these diseases may appear unrelated, but at their core, a common feature emerges, the neuron’s inability to manage intracellular calcium levels thereby creating the catalyst for cell death.

CalciGenix is focused on the discovery, development and commercialization of novel medicines to treat the diseases of aging. Stay tuned for our upcoming news releases and research progress.

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Multiple Sclerosis

The medications currently available to slow down the progression of MS are typically taken on a long-term basis and include interferons (Avonex, Tetseron or Rebif), glatiramer acetate (Copaxone), mitoxantrone (Novantrone), natalizumab (Tysabri), fingolimod (Gilenya), methotrexate, azathioprine (Imuran), intravenous IG, and cyclophosphamide (Cytoxan). According to the National MS Society, data from the most recent annual reports of the leading MS drug companies, including Biogen Idec Inc., Merck Serono S.A., Teva Pharmaceuticals Industries Ltd. and Bayer Schering Pharma AG, report that the worldwide sales of drugs to treat MS will exceed $15.0 billion in 2015.

Westfield

CalciGenix, LLC
1717 Main Street
Suite 5810
Dallas, TX 75201

info@calcigenix.com

Madison ● Dallas

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