Massive FDA Green Light for Leading Bladder Cancer Solution

(Image via Theralase Technologies)

Patience goes a long way in investing, but that is especially true for the healthcare sector. When you’re dealing with potentially life-saving therapeutics and technologies, extra care is needed to verify efficacy for good reason.

While that can make some solutions feel like they’re taking ages to receive a greenlight, long-term healthcare investors and the companies working on those solutions are happy to take their time. Because they know that success can snowball, and each seemingly slow step actually speeds up the rest.

In the multibillion-dollar bladder cancer market, many investors are familiar with the steps that Theralase Technologies Inc. (TSX-V:TLT, OTC:TLTFF, Forum) have taken. The pharmaceutical company has been researching and developing light-activated Photo Dynamic Compounds (PDCs) and their associated drug formulations for the purpose of safely and effectively destroying different types of cancer, and their work on a potential treatment for bladder cancer has continued to advance and draw interest.

It’s not a surprise that Theralase has quietly amassed a following given the potential market on hand. One of the most common forms of cancer, bladder cancer is the sixth-most prevalent cancer in North America and fourth most prevalent cancer for men. The existing treatments for patients suffering from bladder cancer, and especially Non-Muscle Invasive Bladder Cancer (NMIBC), are both in short supply and could be improved upon. And it’s here where Theralase’s lead therapeutic TLD-1433 is making waves.


(Video via Theralase Technologies)

The Company has already progressed to a Phase II Clinical Study for the use of its Photo Dynamic Therapy TLD-1433 in treating NMIBC patients that are unresponsive to the current de-facto treatment, Bacillus Calmette Guerin (BCG). The Phase II Study was launched in Canada at four clinical study sites with one additional site in advanced negotiation, and Theralase plans to expand with approximately 15 additional clinical study sites in the US once it received FDA authorization.

Last week, Theralase received the go ahead to take that vital next step. On May 19, the Company announced the receipt of FDA Investigational New Drug authorization to conduct the Phase II Study in the US. Besides being a major breakthrough that exponentially increases the Company’s patient base and continues it along the path to approval, the fact that the Phase II Study authorization was received in the midst of the coronavirus pandemic cements that the FDA sees TLD-1433 as both promising and necessary.

Shawn Shirazi, the CEO of Theralase, commented on receiving the major authorization and where Theralase can go from here:


But as we mentioned, success in healthcare can often snowball, and the most impressive result of Theralase receiving FDA IND authorization is what comes next. For starters, the Company already signed an agreement in July 2019 with a Trial Management Organization to provide four to six US-based study sites, which can be quickly brought into the fold. Additionally, Theralase has already identified and began the onboarding process with nine US clinical study sites, which it can now move forward with steps leading to enrolling and treating patients.

It’s important to note, however, what the FDA IND authorization means for the future. In earlier discussions, the Company and federal agency agreed that its therapeutic would potentially be eligible for Fast Track Approval based on clinical study data collected to date, after receiving the IND authorization. Further, if Theralase can demonstrate clinically significant results comparable to those observed in the previous Phase Ib study (of a high safety profile and 67% Complete Response), it would potentially be further eligible for Breakthrough Therapy Designation and/or Accelerated Approval.

Now, that a crucial step for Theralase is complete. As economies move towards reopening following the COVID-19 pandemic and clinical studies are able to restart, the Company is set up to carry out its Phase II NMIBC Clinical Study and keep the snowball rolling.


(Image via Theralase Technologies)

The study utilizes the Therapeutic Dose of 0.70 mg/cm2 of TLD-1433 in conjunction with the Company’s proprietary TLC-3200 Medical Laser System to deliver a safe and effective treatment. It has a primary endpoint of efficacy measured by Complete Response ("CR") at any point in time, a secondary endpoint of duration of CR at approximately 360 days post-initial CR, and tertiary endpoint of safety measured by incidence and severity of adverse events grade 4 or higher that do not resolve within approximately 360 days post-initial treatment.

It sounds like a daunting task, but it’s why long-term Theralase investors are thrilled with its paced success. The ongoing Phase II Study has already enrolled and treated 12 patients, and in the follow up to the Company’s previous Phase Ib NMIBC clinical study, patients five and six achieved cancer-free status at 18 months, demonstrating no tumour recurrence, progression or presence of the NMIBC disease. Healthcare innovations are built on proven success and efficacy, after all, and Theralase’s snowball is continuing to build up steam.

For Theralase, the innovation does not only stop at bladder cancer. Moving forward, as Study II advances and a majority of the 20 study sites are open and recruiting patients, the Company expects to expand the scope of treatable diseases, as it has now developed significant expertise and intellectual property around its patented PDCs, with data acquired from preclinical models of human cancers. Theralase has been conducting extensive preclinical research with Rutherrin®, a patented formulation of the Company’s lead PDC, TLD-1433 combined with transferrin. The Company has demonstrated significant anti-cancer efficacy of Rutherrin®, across numerous preclinical models; including: GlioBlastoma Multiforme (“GBM”) and Non-Small Cell Lung Cancer (“NSCLC”). Theralase’s vision is soon becoming a reality, innovating the healthcare sector and treatment possibility to new heights.




FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.