Ogenx Therapeutics Corporation - Science
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Our pipeline consists of a family of 35 proprietary drugs that we call "Redoxagens". These novel drugs represent a new therapeutic class of stabilized, highly active molecules that are rationally designed to upregulate the production of ROS signaling molecules at failing (oxidately stressed) redox loci in the mitochondria. This pharmacologically controlled ROS generation is designed to aid in promoting the induction of ROS-mediated cellular self-repair mechanisms and the normalization of native respiratory pathways at the most fundamental level of eukaryotic cellular metabolism. The Redoxagens have preliminarily demonstrated safety and efficacy in a variety of serious diseases in small pilot studies in both animals and man where there are significant unmet medical needs.


Use of Redoxagens in Humans and Animals:

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RC-1 Alpha in Human Age-Related Macular Degeneration

Age-related Macular Degeneration (AMD) is the most common cause of vision loss in people over age 50.


AMD occurs in two forms: Dry AMD (DAMD) and Wet AMD (WAMD). Degeneration starts with DAMD, which can sometimes quickly deteriorate into WAMD. Several therapies are available for WAMD such as Eylea ,Macugen, Lucentis, Avastin and others, which are capable of bringing WAMD back to DAMD, but do not reverse the damage. As for the Dry AMD itself, currently there is no FDA-approved pharmacological treatment available and an estimated 15 million people in US and ~80 million worldwide are progressively loosing their central vision without hope of ever regaining it and seening clearly again.

One of our compounds - RC-1 Alpha was studied in human volunteers with the informed consent under the provisions of Food and Drug Administration Act Modified in 1997 (FDAMA 1997). In a 76 patient observational trial RC-1 Alpha appeared to confer a clinically relevant (about 3 lines) enhancement in vision for patients with Category 2-3 D-AMD.
Recently we confirmed results of this initial study in the IRB-sponsored RAVEN-1 trial using Optical Coherence Tomography, a state of the art technique designed to study morphological structures of the eye. Above are the pictures of one of the patient's eyes before and after the treatment. RC-1 Alpha was not only capable of restoring 3.2 lines of vision, but also have regrown cells constituting retinal pigmental epitheluim - orange line on the retina scan.

RC-2 Beta in Canine Mast Cell Tumor

Canine Mast Cell Tumor (MCT) is one of the most common cancers in dogs. Here is a story of Charlotte.

Existing treatments - surgery, radiation and common chemotherapy may extend the life of furry patients by few months at best. Here is a story of Charlotte, a 9 year old female spayed chocolate labrador that has been treated with RC-2 Beta.

RC-2 Beta in Canine Lymphosarcoma

Canine Lymphosarcoma (LS) is one of the most common cancers in dogs.

Existing treatments - surgery, radiation and common chemotherapy may extend the life of furry patients by few months at best. 10 dogs with lymphoma cancers were treated with RC-2 Beta using IV injections. No significant toxicities observed. Significant improvement in quality of life, extension of life or cure.

RC-2 Beta in Equine Parasytic Diseases

Redoxagens were used to treat over 8'000 horses with Equine Protozoal Myeloencephalitis.

Equine Protozoal Myeloencephalitis (EPM) is a costly, debilitating and, if untreated, universally fatal neurodegenerative disease of horses; with the causative agent being a protozoal infection from Sarcocystis neurona. In 344-horse observational study, Redoxagen RC-2 Beta was shown to be a remarkably effective treatment for EPM, with several distinct advantages over conventional treatments: 1) no undesirable drug-related side effects; 2) ease and short duration of the RC-2 Beta treatment provided a more practical and economical option than any other therapies; 3) full recovery was remarkable and unprecedented; 4) intravenous delivery series proves that RC-2 Beta is capable of readily crossing the blood-brain barrier. While further controlled and randomized studies with a commercial product are required, the large number of resolved EPM cases in this study suggests that the RC-2 Beta treatment is far superior to any current treatment for EPM.

Here is Halu Baloo with EPM hours from death. Pulling a tail on a healthy horse is big no-no, but horses with EPM allow this to happen.


Here is Halu Baloo after one week/6 injections with RC-2 Beta. Virtual majority of horses treated with conventional paliative care succumb to the disease by this time.

RC-2 Beta in Equine Squamous Cell Carcinoma

Story of Rainey, a horse with Squamous Cell Carcinoma cancer.

Six treatments over 4 weeks of 3cc RC-2 Beta in 100cc of normal sterile saline administered intravenously via jugular bolus. No other drugs were used. Pre-treatment and follow-up biopsies, performed with photographic documentation, showed complete resolution of the tumor, restoration of normal structures and healing.

Redoxagen Toxicology

Rats were able to tolerate doses of up to x1500 (one thousand five hundred) of human therapeutic dose.

Massive overdose studies have been performed in rabbits and rats which demonstrate a significant therapeutic window relating to the Redoxagens' drug safety profile. Both RC-1 Alpha and RC-2 Beta have been tested at doses of up to 1,500x (68mg/kg) therapeutic human dose (THD) of that used in Human Dry AMD studies (1cc of 1% in 100cc saline delivered IV) in a massive overdose toxicity studies and demonstrated a significant therapeutic window. Low toxicity of Redoxagens is linked to the chemistry and MoA of their API, Geroxane - once Geroxane is consumed producing the ROS burst, redox activity returns to normal = no chronic toxicity. Moreover, ROS and mitochondrial substrates potentiate Redoxagen action - making their action specific to redox sites of ETC and PMRS. This results in dual mode of action: (a) in normal cells redox activity is confined to mitochondria – Redoxagens potentiate redox-mediated cellular self-repair signaling; b) in cancerous or cells with severe oxidative stress energy production is carried out via glycolysis and redox activity is confined to cytosol - activation of Redoxagens results in ROS burst in cytosol that triggers on cell death.


OGENX THERAPEUTICS' DISCLAIMER AND FORWARD-LOOKING STATEMENT

These press releases include forward-looking statements regarding OgenX's financial position and outlook and OgenX's business. Any statement describing OgenX's goals, expectations, financial or other projections, intentions or beliefs, including the planned commercialization of RC-1 Alpha or RC-2 Beta, or any other product candidate, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for uses as human or animal therapeutics, and in the endeavor of building a business around such drugs. OgenX's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although OgenX's forward-looking statement reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by OgenX. RC-1 Alpha or RC-2 Beta are experimental compounds and the claims regarding clinical efficacy or safety were never evaluated by Food and Drug Administration. As a result, you are cautioned not to rely on these forward-looking statements. In these inormation entries, unless the context requires otherwise, "OgenX", "Company", "we", "our" and "us" refers to OgenX Therapeutics Corporation. OgenXTM, RedoxagenTM, RC-1 AlphaTM and RC-2 BetaTM are trademarks of OgenX Therapeutics Corporation.