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This was the most powerful PR in a very long time,
but what a muted response! It'll take total success to
overcome the stench the former ceo has cast on this stock.
16 1/2 cents for a potential cancer cure? Does that smell right?
If you think the last raise was a smart move, I would agree, it was great for one person and his buddies, Roger. Yes, he has a middle manager for auto assembly degree, and a nose for great science, like PDT's and McFarland's work, but he's basically in it for himself first (and his wife CFO and friends), but he's running the show from behind the scenes. There are many brown-nosed apologists for his poor business decisions-- the latest being the silly way the money raise was conducted so he, and his, could come away with lots of cheap shares. My goodness, at what cost!
Now with what we know to be one patient treated in 2 months, you begin to wonder what our beloved boss has in store for us, what he isn't saying. My disclosure: I haven't liked the guy since I spoke to him years ago because he sounded too much like a promoter rather than a shareholder supporter, but I like the science too much to stay away.
Cancer cells do not have a chance against PDC's. They are doomed because of their proclivity to acquire iron. Now, if they get the dosing heavy enough and the laser igniter strong enough so that all the PDC is activated, then even the beginning cancer cells considering being a nuisance will be destroyed, inside out. Once this gets approved: McFarland for Nobel Prize!
Hey, these guys must be getting serious
about global commercialization. Yah think? There'll be some powerful SP moves once some early data from Phase 2 comes, or,
a funding is announced.
Am I the only one who feels PWC failed in their
fiduciary duty, to keep the public properly informed.
On July 18, '18, PWC leaked, intentionally or mistakenly,
in the 3rd Report, that there were two QB's. The public then assumed that there were 2 companies posed to make qualified bids; that is, until
the public was blindsided by the Eno letter of July 31, '18, that
there were in fact no qb's made, and the co. would be proceeding
to liquidation. The public only found out,
in the 4th Report, that the qb's withdrew from the process, so
there were in fact NO qb's after all. PWC, which knew they had
erred in leaking the qb's, and which knew that some of the
investing public could've been relying on that fact, should have
made a public statement to the fact as those qb's were withdrawn
from the process. So the investing public should have been fore-
warned so they could have adjusted their expectations. Everyone who lost
big when the stock went from .07+ to .01+ should be entitled to compensation
from PWC!
The contention is that PWC, having mistakenly publicized that there were 2 good bidders, should have indicated also when those bidders withdrew their bids, BEFORE the stockholders were blindsided w/ the CEO's letter that NO bidders were interested, making the stock crash. What YOU reference is letting shareholders know AFTER the fact, after the CEO's letter came out.
Does anyone know of a PWC class action suit for inadvertently divulging that there were 2 qualified bidders which gave false hope to many. I lost a lot on that fact. If they knew the public was aware of that fact, then they should have also informed the public of their bid withdrawals.
Good job, Penman, right on topic.
What happened to PWC transparency?? They under the spell of
Richard "the dick" Eno, trying to make it tough on the retailers??
If it was the same person who told you that you could
pick up some 5's in the last 2 trading days, which you were so sure you could do, then you can trash that idea.
Shorts covering as fast as they can.
r u buckled up? BLAST OFF!!!
Too many want in for less than .10. eom
I doubt the MM's will get it to drift down. Too many folks
know there's too much $$$$ on the table not to buy in, especially on any dips.
Hard to see how one can lose on this play; everything points to a nice "practically risk-free" bet at this level.
Group of retailers orchestrated a mid-7's dumping party; otherwise we'd have closed close to 8. They look for buying fatigue and sell.
the MM's are masters at getting buyers to chase, and to get the sellers to sell from fear it'd drop further.
Hopefully, we'll get a PWC update today; it's due.
Is Bioamber trading in Canada today? How's it doing?
Looks like a cup & handle configuration will lead this to fly northward soon.
You mean several "hundred" million, right?
How low can a stock go? Can it go to .0001 or below?
How about going negative, when the company has to pay you to hold the stock?
can someone explain what's going on? why the buying?
Still supportive and bullish on this company w/ over 1/2 million shares.
Theralase Successfully Completes Phase Ib Non-Muscle Invasive Bladder Cancer Clinical Study
Theralase Medical and Scientific Advisory Board concluded that the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”) has met its objectives and unanimously voted for the early termination of the Study based on successfully achieving its primary and secondary endpoints after six patients.
Toronto, Ontario – May 30, 2018, Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy cancer has successfully completed the Study.
On May 19, 2018, Theralase’s Medical and Scientific Advisory Board (“MSAB”) was convened to examine the clinical results obtained on the first six patients enrolled and treated in the Study utilizing TLD-1433-based Photo Dynamic Therapy (“PDT”); specifically: the primary endpoint of safety and tolerability, the secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and
the exploratory endpoint of efficacy primarily at 90 days.
The MSAB is comprised of world-renowned experts in bladder cancer and have been retained by the Company to provide advice and strategic guidance on the research, development and commercialization of the TLD-1433-based PDT technology in the treatment of patients inflicted with NMIBC.
After reviewing the clinical data presented by Girish Kulkarni, MD, PhD, FRCSC, an Associate Professor at the University of Toronto, Department of Surgery and the Principal Investigator of the Study, the MSAB unanimously recommended the early termination of the Study due to achievement of the primary and secondary endpoints. The MSAB also recommended that the clinical data collected from the first three patients treated at the Maximum Recommended Starting Dose (“MRSD”) (0.35 mg/cm2) and the three patients treated at the Therapeutic Dose (0.70 mg/cm2) were sufficient to support the conclusion that the Study had successfully achieved the Study’s primary and secondary endpoints and had adequately addressed the Study’s scientific, technical and clinical questions, as per the approved Study design and clinical protocol. The MSAB recommendation to the Company was to terminate the Study based on the six patients treated to date and suggested that the Company pursue a pivotal Phase II NMIBC clinical study approval with Health Canada and the FDA with efficacy as the primary endpoint.
Dr. Kulkarni stated that, “The primary and secondary endpoints of the Study have been successfully accomplished from a clinical aspect. The treatment was safe and well tolerated by all patients treated, with no discernible difference in the number or severity of Adverse Events (“AEs”), regardless of whether the MRSD or Therapeutic Dose was utilized. All AEs were either minor (Grade 1) or moderate (Grade 2) in severity and completely resolved within 90 days. There were no severe (Grade 3), life threatening (Grade 4) or deaths (Grade 5) AEs and the majority of AEs were transient and related to irritative lower urinary tract symptoms (i.e.: urination urgency). TLD-1433 systemic absorption was minimal (picograms concentration in plasma), which is magnitudes below the No Observed Adverse Effect Level (“NOAEL”) for TLD-1433 and hence presents no significant clinical risk. I believe that TLD-1433 holds real potential as a treatment for NMIBC and I look forward to treating patients in a pivotal Phase II NMIBC clinical study, pending Health Canada approval to commence the study.
Michael Jewett, MD, FRCSC, FACS, Professor of Surgery (Urology) at the University of Toronto and the Chairman of Theralase’s MSAB stated that, “When NMIBC intravesical treatment with Bacillus Calmete Guérin (“BCG”) fails, the standard of care is cystectomy (removal of the patient's bladder), which is a major surgery with life-altering side effects that many patients may not accept despite the risk of cancer spread. The Study clinical data presented by Dr. Kulkarni is very encouraging. TLD-1433 PDT appears safe and well-tolerated in patients presenting with BCG-Unresponsive NMIBC. I am pleased that the clinical results of the Study met its objectives demonstrating that the Theralase PDT technology has demonstrated potential as a treatment for bladder cancer. The MSAB members and I unanimously support the view that the Study achieved its primary and secondary endpoints after the treatment of 6 patients and concluded that the clinical data collected supports an early termination of the Phase I Study to commence a pivotal Phase II NMIBC clinical study focused on efficacy. The Phase II NMIBC study design has been discussed and collectively approved during the MSAB meeting. The exploratory endpoint of efficacy is extremely encouraging as the fifth and sixth patients are clinically cancer free as of the ninety day cystoscopy examination."
Ashish Kamat, MD, MBBS, Professor of Urologic Oncology (Surgery) and Wayne B. Duddlesten Professor of Cancer Research, University of Texas, MD Anderson Cancer Center stated that, “The safety data presented by Dr Kulkarni and Theralase is convincing and recruitment of an additional three patients at the Therapeutic Dose is not likely to add significant value to the understanding of the PDT technology in the treatment of NMIBC. If a larger multicenter study demonstrates efficacy of PDT technology in this patient population, it would provide our patients a useful alternative to avoid radical surgery. The more safe, reliable options we have to offer our patients, the better it is for everyone concerned. The MSAB thus recommended that the Company truncate the Study early to seek Health Canada and FDA approval to commence a larger and more statistically powered, single arm, multicenter efficacy study. Moreover, the MSAB reviewed and approved in principle the Phase II clinical protocol and the clinical study design presented by Dr. Jewett. BCG-Unresponsive NMIBC is a potentially fatal disease that requires additional treatment options. Currently, cystectomy remains the safest treatment option available to patients, but if the Theralase PDT achieves its efficacy endpoint in a Phase II clinical study, then this will present patients with an attractive additional treatment option. The clinical data presented by Dr. Kulkarni suggests that the Theralase PDT treatment option may be just what the doctor ordered.”
Michael O’Donnell, MD, Professor of Urology, University of Iowa, Iowa City, Iowa stated, “I’m encouraged by the Theralase Phase Ib clinical study data presented at the MSAB meeting. The top-line clinical results indicate that the TLD-1433-based PDT at tested doses has met its primary and secondary objectives in the studied population of BCG-Unresponsive patients with NMIBC who refused cystectomy. The Theralase approach is an interesting treatment option with an early signal of treatment effectiveness, albeit in a small population, that will need to be confirmed in a Phase II clinical study. This is a novel approach that addresses a bladder cancer population with a high unmet need. As designed, a successful Phase II clinical study will confirm how this PDT therapy approach could shape future practice.”
About the Study
The Study is being used to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy.
Study Outcome Endpoints:
1) Primary: Evaluate safety and tolerability. (Measured by patients who experience Adverse Events (“AEs”) Grade 4 or greater that do not resolve within thirty (30) days; whereby: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death)
2) Secondary: Evaluate the pharmacokinetics. (movement and exit of drug within tissue) of TLD-1433 (Measured by TLD-1433 concentration levels in plasma and urine over 72 hours.)
3) Exploratory: Evaluate efficacy. (Measured by Recurrence Free Survival (“RFS”), defined as the interval from Day 0 (Day of PDT treatment) to documented recurrence or death from any cause, whichever occurs first. Recurrence is defined as any new tumour growth (i.e.: any biopsy-confirmed new or recurrent tumour), evaluated at 90 days for the first three patients treated at the MRSD and primarily at 90 days for the last six patients treated at the Therapeutic Dose and secondarily at 180 days post treatment)
The Company is planning to meet with Health Canada and FDA, to discuss and finalize the design of a Health Canada and FDA pivotal Phase II NMIBC clinical study, with a primary endpoint of efficacy.
About Theralase Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy cancer. The Company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint conditions.
Additional information is available at www.theralase.com and www.sedar.com .
This news release contains "forward-looking statements"
That's a BIG dump today; must've made someone feel good.
We all know that if P2 is stellar we'll get a triple here, but
less than that, we'll be sitting in the low 30's. Is it worth
the risk?
That's a BIG dump today; must've made someone feel good.
We all know that if P2 is stellar we'll get a triple here, but
less than that, we'll be sitting in the low 30's. Is it worth
the risk?
This stock....
has been nothing but good to me so far and I hope it continues that way. That's based on nothing but hope based on the CEO flashing some of his magic since I don't see how it can compete with the big fintech players.
Heavy buzz beginning on TLTFF
latest news: proven cancer killer with laser activated PDCs.
Where's the risk,
now that efficacy has been demonstrated?
It is still a wonder how the successful completion of this study was kept secret from the public for the past several days.
That's great news!! Theralase Successfully Achieves Primary and Secondary Objectives for First Three Patients Treated Using Anti-Cancer Technology for Bladder Cancer
Toronto, Ontario – May 26, 2017, Theralase Technologies Inc. announced today that the independent Data and Safety Monitoring Board (“DSMB”) has unanimously decided that the primary and secondary objectives for the first part of the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”) have successfully been met.
Princess Margaret Cancer Centre, University Health Network (“UHN”), in accordance with the DSMB’s decision, is now recommended to enroll an additional six patients for the second part of the Study, treating them at a therapeutic dose of the PDC (0.70 mg/kg) for NMIBC using its novel Photo Dynamic Therapy (“PDT”) technology.
The DSMB is comprised of three highly regarded, independent uro-oncologists; specifically: Dr. Laurence Klotz of Sunnybrook Health Sciences Centre, Dr. Nathan Perlis of the University of Toronto and Dr. Alexandre Zlotta of Mount Sinai Hospital.
The clinical data on the first three patients was presented by Dr. Michael Jewett, Chair of the Medical and Scientific Advisory Board (“MSAB”).
Why bother the guy? A NR by the end of the month is what has been expected all along(30 days after the last exam). Isn't it odd, though, that no one is leaking the results, or maybe the results are oh hum, the 3 had a little bladder wall irritation, so it can't be said that it was a raging safety success/that there was NO problem with the procedure, and although it "seemed" like there was visual bladder wall improvement, it can't be said for sure without a biopsy whether cancer was destroyed. So with a report like that, how would folks vote with their $?
CONGRATULATIONS!!
especially to the clinicians/lab techs at the hospital for keeping the results secret, good or bad, of the first 3 patients. They are probably clueless what a momentous gamechanging technology they are dealing with.
Hopefully procedural tolerance is there and some efficacy shows; that'll be a recipe for ferocious (almost animal-like) buying of the stock.
Just don't trust Doulin, the guy that touted that there was plenty of $ in a financing shelf (on the Kereport)2 days before doing another placement at a 30% discount. I hope he doesn't pull another fast one like that on us shareholders.
And ignore whatever he states about the laser division. He's given the meaningless sales "gaining traction" multiple times; he just should come out and say, honestly it's not doing too well, not nearly what we want it to do.
Someone throw some cold water on me; this stock is getting HOT!
I've been watching, following everything closely, buying enough so for ea. $1 it goes up I'll pocket $100K. More power and safety than Photofrin which was proven to knock out 90% of the bladder cancer cells. May the odds be with us.
This should be stickied. Don't know who wrote this,
but it sure exposes AF as a biased and unbelievable analyst.
What, me worry?
Not in the slightest degree. The sp has been down here before. We've got several suits pulling down monster salaries with no revenue or deals and Aspire selling the hell out of the stock so any more financing can be done at rock bottom prices. Who's worried?
The suits compensation should be hinged to stock performance. We'll give them $85k yearly if the stock is lower than 1.50, $150k to 2.50, etc.. They're acting like this is a $6.00 stock. I'll float this idea at the annual meeting.
Glad I p/u 30k more shares at .273 yesterday.
No More Waiting!! This approval confers great legitimacy to the company's science and it's plans.
When Canada's OK happens, this stock
should EXPLODE!