Lightning Strikes Twice: A SECOND Patient Cancer-Free After 1 Year
On January 31, 2019; Theralase Technologies Inc. (TSX: V.TLT, OTCQB: TLTFF, Forum) reported that Patient Five in its anti-cancer clinical study demonstrated a Complete Response (CR) after 360 days, i.e. was cancer-free 360 days after receiving a single treatment with TLD-1433 – a revolutionary anti-cancer drug being pioneered by the Company.
This research centers around a form of bladder cancer: non-muscle invasive bladder cancer (NMIBC). Bladder cancer is a multi-billion dollar cancer treatment market (in the United States alone). NMIBC is a form of bladder cancer for which existing treatment options provide a very low success rate.
On April 2, 2019; Theralase announced that they did it again. Patient Six in the Company’s Phase Ib clinical study is also cancer-free after 360 days, and also after only a single treatment with TLD-1433.
Theralase’s “Trojan Horse” anti-cancer research is becoming increasingly familiar to the Stockhouse audience. We first introduced the Company (and TLD-1433) to Stockhouse in a full-length feature article from April 13, 2017.
Trojan Horse? TLD-1433 can’t kill a single cancer cell – by itself. Rather, this “photo-dynamic compound” (PDC) is a cancer infiltrator. In essence, Theralase disguises TLD-1433 to resemble one of the favorite nutrients of cancer cells: iron.
Through its chemical disguise, TLD-1433 sneaks past the tough outer wall of cancer cells. And it’s only once TLD-1433 is “inside the walls” that the cancer-killing begins. TLD-1433 is activated through the application of laser light that can destroy the cancer-infected bladder tissue. TLD-1433 and 90 J/cm of green laser light delivered by TLC-3200 (a Laser Light System) is able to effectively destroy NMIBC for up to 1 year after a single treatment.
Because this is non-thermal and non-ionising laser light, it has virtually no impact on (non-cancerous) surrounding tissue. Inside the cancer cells, however, it’s a completely different story. The laser light triggers a chemical reaction that produces a potent cancer-killing substance that destroys these cells from within.
It sounds too good to be true, given the conventional brute-force methods of cancer treatment with which we are all familiar: chemotherapy, radiation therapy, and (of course) surgery. With conventional cancer therapies, the “cure” is literally almost as bad as the disease.
In contrast, Theralase’s ingenious cancer research is benign. And it’s working.
The Company has now completed its Phase Ib study and is preparing to advance to a Phase II study: the formal demonstration of efficacy. Even before Phase II; however, Theralase has already generated some very exciting results from Phase Ib.
The final three patients in the study (Patients 4, 5 and 6) were enrolled and treated at the Therapeutic Dose for TLD-1433. Theralase is now reporting that two of these three patients – Patient 5 and Patient 6 – are cancer-free 360 days after a single treatment of TLD-1433.
The Company is referring to these exciting results as a “66% CR” (Complete Response), after receiving only a single Anti-Cancer Treatment (ACT). Patient 4 was diagnosed with pre-existing and non-Study related “metastatic disease” and as a result was excluded from further study.
Dr. Shawn Shirazi, Chief Executive Officer of the Drug Division commented on this latest success.
“The latest data received on patient six is extremely encouraging, in that it demonstrates after only one Theralase ACT, CR at 90 and 360 days post-treatment is achievable. If the efficacy results obtained to date are able to be replicated in a larger patient population, via a well-designed Phase II NMIBC clinical study, with a demonstrated CR at 90 days and duration of CR at 360 days post-treatment, then the Theralase ACT has the potential to be the next gold standard in the treatment of NMIBC. Theralase is highly encouraged by this recent data demonstrating that BCG-Unresponsive NMIBC patients, who refused or were ineligible to undergo a radical cystectomy (bladder removal surgery) have remained cancer free at 360 days post Theralase ACT, achieving cancer-free status beyond their previous clinical experience living with this devastating disease. Pending successful commencement of Study II, the Company plans to investigate the commencement of an additional Phase Ib clinical study for a new cancer indication.” [emphasis mine]
Taking patients who were at an advanced “unresponsive” stage of cancer and leaving them cancer-free, after one year, with one treatment of a benign, minimally invasive treatment. Big news. And now on to a Phase II clinical study (again with human patients) to formally demonstrate the efficacy of this treatment.
Theralase’s TLD-1433 is approaching the stage in the formal drug approval process where this cancer treatment can be commercialized. Meanwhile, the Company has additional, related initiatives in its R&D pipeline. These parallel initiatives apply the same cancer-infiltration strategy, modified for the specific variant of cancer being treated.
Cancer can be beaten. However, being able to do so at an advanced stage, with a high degree of success, and with a benign treatment is revolutionary. For investors, this has extremely lucrative potential, not only in the multi-billion market for bladder cancer treatment, but (potentially) with other forms of cancer as well
