Influenza/Colds/Novel Respiratory Viruses

 

Our testing shows that TA is a very broad-spectrum antiviral drug, effective against Influenza A and B, and likely part of the first line of defense against the recurring pandemic respiratory viruses.  It also appears to be effective against cold viruses.  TA could be developed as a monotherapy, but combinations with existing therapies would also make therapeutic as well as strategic sense.

Extensive method and composition patent filings covering synthetic analogs, derivatives, and mimetics, and a new means of administration not currently on the market for TA, provide protectability.

We believe our current data allows the beginning of Phase 2/3 clinical studies now, using TA alone or in combinations.  Expedited handling by the FDA should be available.

Cold Sores and Other Herpes Indications

Our testing indicates that TA is far more effective than the current herpes therapies on the market.  Our testing also shows that TA could be combined advantageously with the current therapies.  It is synergistic with acyclovir (they are more effective combined than either alone), but TA is effective against acyclovir-resistant strains, and when optimized, the combination of  TA and acyclovir prevent the occurrence of acyclovir-resistant mutants.

The largest herpes indication is cold sores.  Extension to other indications could follow – genital herpes, shingles, cytomegalovirus.  Unmet needs for orphan indications are also available: herpetic stromal keratitis, which can cause blindness, and treatment of drug-resistant strains of genital herpes in immunocompromised patients.

In addition to treating outbreaks, our limited testing has shown that a TA gel or cream applied daily would provide a significant reduction of the incidence of herpes outbreaks.

Extensive method and composition patent filings, new and enhanced functionality, and a new means of administration not currently on the market for TA provide protectability.

We believe our current data would allow the beginning of Phase 2/3 studies now, using TA alone or in combination with another established therapy.

COVID-19

We are testing TA against SARS-CoV-2, alone and in combination with other therapies currently being used and new ones in development.  TA is ready for use now in clinical trials, alone or in combination with other drugs, at its currently used dosage for certain therapeutic benefits.  Novel doses are expected to provide additional therapeutic functions and benefits.  (UAB has commenced clinical studies using TA at its currently recommended dosage for inhibition of plasmin formation in patients upon entering the hospital and in newly diagnosed outpatients, based on information that patients with co-morbid conditions who fare poorly with the virus typically have elevated levels of plasmin, which adds to virulence (Ji et al., 2020).)

Anti-Aging

We have been issued a US patent covering the use of TA and other antifibrinolytics for anti-aging effects.  Our lead product will be a topical facial TA gel or lotion to reduce fine lines and wrinkles.  By reducing the production of plasmin and through other mechanisms, TA has been shown in extensive animal and (in part) human research to reduce the degradation of collagen, maintain skin flexibility and thickness, reduce inflammation, support the immune system, improve mitochondrial function, reduce melasma (dark spots) and rosacea, and avoid development of skin cancers.  In addition, we believe that a daily use TA facial product will reduce the number of cold sore outbreaks based on our in vitro and animal research and limited clinical cases using TA against the Herpes virus.  A facial product with FDA approval for the reduction of fine lines and wrinkles through improved skin health (as opposed simply to increased hydration or injection of foreign materials) that also serves to reduce cold sore outbreaks, melasma, and possibly skin cancers will be a blockbuster in the $150 billion global skin care market.

Ongoing product line extensions could include a body cream for the same benefits for the skin on other parts of the body.  Topical products for treatment of outbreaks of Herpes (cold sores, genital, shingles, other), possibly with a higher concentration of TA, could also be included.  A daily oral product will also be considered, since it has been shown in mice to improve skin and overall health, and extend the lifespan.  Effects in mice are not always obtained in humans, but TA’s proven effects in humans listed above such as reducing inflammation, improving the immune system, and reducing viral outbreaks could logically provide improvement in overall health, reduced susceptibility to disease, and increased lifespan.

Cancer

We are currently testing TA alone and in combination with new therapies against different cancers, with very positive results.  Leukemia, lymphoma, and triple negative breast cancer appear to be particularly good targets, as well as cancers for which TA can be applied topically, like melanoma.  Some anti-cancer properties of TA have been previously noted but none that led to adoption of a treatment option for therapeutic use.  Our testing has revealed fundamental new anti-cancer mechanisms of TA that can be used for distinct oncology targets, or combined with other drugs for the benefits of combinations described below.  We expect to be ready soon for Phase 2 studies.

Drug Combinations

Because of TA’s ability to treat a broad number of diseases either through direct effects or its significant secondary benefits described in Our Technology, the combination of TA with other drugs currently in use, in development, or that have failed in development represents a significant opportunity.

Benefits of combinations with TA include:

– Enhanced effectiveness

– Broader indications

– Lower dosage, allowing reduced toxicity, if applicable

– Reduced susceptibility to resistance

– Patent life extension or recovery for an approved drug

– Enhancement of an established brand or technology

– Rescue of a drug candidate that failed in a later stage of development