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).)

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