Here are some of my personal highlights from the piece.
I don't attest to being a medical expert, but the medical professionals that write and publish peer-reviewed papers are.
There have been three peer reviewed papers published that validate the company’s statements of efficacy in these compounds’ ability to annihilate bacteria, viruses and cancer cells.
One, by the American Society for Microbiology, published in February 2013, concluded:
“There is a recent recognition that Ru(II) (Ruthenium compounds) complexes might prove useful as Photo Dynamic agents, particularly for virulent strains of infectious disease including gram-negative pathogens, owing to their intrinsic cationic charge. However, these Photo Sensitizers (PSs) will continue to suffer from the inability to destroy microbial targets at low oxygen tension, and since precise knowledge of oxygen tension in a wound, for example, is not possible, the best PDI agent will be one that can function regardless of oxygen tension. In this report, we have demonstrated that it is possible to instill Type I activity into a simple mononuclear Ru(II) complex using principles derived from coordination and materials chemistry. This activity was outlined in Staphylococcus aureus (S. aureus or SA) and Methicillin Resistant Staphylococcus aureus (MRSA) in hypoxia, and proved to be as effective, or more effective in some cases, than normoxia. Equally important, the TLD1400 series is active at concentrations of over 3 orders of magnitude lower than the gold standard PS Methylene Blue (MB). This photodynamic potency applies to bacterial cells and cancer cells alike, and therefore, represents a new paradigm for designing Type I PS using Ru(II) that extends to other clinical applications.”
In another published paper The Royal Society of Chemistry stated
“To improve the effective elimination of tumours by Photo Dynamic Therapy (PDT), PSs with a range of 10 photophysical and photobiological attributes must be developed, including: specific cellular and subcellular targeting, maintenance of high cytotoxic load in oxygen-depleted environments and activation by light with necessary penetration depths, but sufficient photon quantum energy to produce cytotoxic Reactive Oxygen Species (ROS). Thus, an ideal PS should be a chemically pure compound with high tissue and cellular selectivity that (i) exhibits long wavelength absorptions preferably at wavelengths (>670nm) to provide larger tissue penetration depths (e-1 attenuation depth), (ii) possesses a short injection to light time interval (drug-light interval), (iii) has low dark toxicity, but strong photo cytotoxicity, and (iv) rapidly clears from the system."
This precisely describes Theralase’s TLD1400 series PDCs.
So a small Phase 1 / 2a clinical trial, which was successful in demonstrating the safety, tolerability and efficacy of the treatment could potentially qualify for Breakthrough Status.
If the company was granted Breakthrough Status, the FDA works hand in hand with the company to minimize the time to commercialization to a bare minimum.
“So if all the stars are in alignment,” continued Demoulin-White, “after completion of our preclinical research this year, successful completion of our Phase 1 / 2a human clinical trial in 2015, and we are lucky enough to successfully petition the FDA to achieve Breakthrough Status, our PDC technology could be available to treat patients suffering from bladder cancer by early 2016.
If we were not able to achieve Breakthrough Status, we would still be eligible for Fast Track approval, which even with a Phase 2B or Phase 3 clinical study, would only delay commercialization an additional two to five years.
In parallel to this strategy, we would be actively looking for a co-development partner, most likely big pharma in order to aid in the distribution of this revolutionary technology to locations throughout North America and in due course the world."
If Theralase can successfully petition for Breakthrough Status, the Company would have the ability to commercialize rapidly - as early as 2016. The bladder cancer market alone is a $4 billion industry, not to mention the potential for spin-offs that not only has Theralase been working on (see their latest press release), but also peers within the industry.
Theralase has gotten back excellent lab results, and have already tested their PDCs against the two other FDA approved PDCs that are currently on the market - Theralase PDCs drastically outperformed the others (ALA and Photofrin).
Granted Theralase is in its early stages, but the risk/reward scenario here is significant.
There is some paper that becomes free trading at the beginning of March, so over the next few months would be an excellent time to start a position.
