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Theralase Technologies Inc. On The Brink Of A Photo Dynamic Cure For Cancer

|Includes: Theralase Technologies Inc. (TLTFF)

Theralase Technologies Inc. TLT.v/TLTFF otcbb

http://theralase.com/

Theralase Technologies Inc. is company on the cutting edge of using light to cure. One part of the company is therapeutic. They sell Therapeutic Laser Technology that is used for a wide variety of therapeutic and healing applications and by a wide variety of medical professionals. But that's not currently the interesting part.

The VERY exciting part is Photo Dynamic Therapy: a treatment that combines safe, targeted drugs activated by laser light that has successfully treated various forms of cancer in a lab setting. It is a remarkably brief and effective treatment compared to any other cancer treatment available. And Theralase has now begun low dose human trials to test for safety (not efficacy yet, though evidence of efficacy may be present in results) non-muscle invasive bladder cancer. Those of you familiar with the process involved in getting to the human trial stage will know how significant this step it. The trial is being run entirely by the world renowned cancer treatment center at Princess Margaret Hospital. Theralase is looking for no less than to replace Keytruda as a bladder cancer treatment.

Theralase's PDT treatment is exponentially exciting because it has the potential to be adapted to a wide variety of cancers. Trials for treatment of brain cancer are on deck for the end of Q4 2017 and lung and breast cancers (among others) are distinct possibilities - not to mention a variety of cancers treatable in animals in the veterinary field.

I'm not a medical expert so I've cobbled together a series of links and excerpts from bullboard posts and interviews. The website contains a wealth of information. I see it as an incredible opportunity for a stock currently in the neighbourhood of .35. It doesn't take much imagination to see the potential for a parabolic rise in share price. Look at any company that has a cancer drug in the system and you'll know what I mean.

The results for safety from their first patient should be in by the end of April/beginning of May, 2017, with the others following not long after. Once safety is established, they will follow through with a full dose for efficacy, but I suspect .35 will be long gone at that point. A year or so down the line, trials successful (or even partially successful), this will be north of $20 - the more you read, the more you'll agree. Do your own DD - I think you'll like what you see.

Why Invest? http://theralase.com/invest/

Photo Dynamic Therapy (NYSE:PDT)

Theralase develops advanced pharmaceutical products and medical devices based on proprietary non-immunosuppressive photodynamic technology, targeting key health care and oncology markets. Theralase's strategy is to build a specialty Biopharma company by developing and commercializing new and innovative products based on its patented photodynamic compounds, lasers, drug and light delivery systems, personalized and a patient specific platform technologies. Theralase's strategy in oncology is to continue the research & development of the anti-cancer portfolio, with transition metal -based Photodynamic Compounds (DDCs) and other new anti-cancer products, and build a commercial platform in Canada and US for clinical use worldwide.

Therapeutic Laser Technology (NYSEARCA:TLT)

The Therapeutic Laser Technology Division, which focuses on the development and commercialization of laser-based biomodulation, a non-invasive reparative biomedical platform technology targeting tissue inflammation, degeneration and pain. The FDA, Health Canada and CE have approved our core advanced therapeutic laser technology.

Korelin Economics Report - KE Report Commentary: Interviews with Roger White, CEO and President of Theralase:

April 6, 2017 http://www.kereport.com/2017/04/06/comprehensive-update-theralase/

Tues, Jan 17, 2017 http://www.kereport.com/2017/01/17/date-theralase-beginning-phase-1b-clinical-trial/

Toronto, Ontario - April 6, 2017 Theralase Technologies Inc. ("Theralase®" or the "Company") (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical lasers to eliminate pain and the development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that its latest research has been accepted for peer reviewed publication, demonstrating that a new class of anti-cancer PDCs based on the metal Osmium ("Os") may be very effective in the destruction of cancer.http://theralase.com/pressrelease/theralase-announces-acceptance-of-peer-reviewed-publication-for-next-generation-anti-cancer-drugs/

Toronto, Ontario - April 4, 2017 Theralase Technologies Inc. ("Theralase®" or the "Company") (TLT: TSXV) (TLTFF: OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that the first patient was treated on March 30, 2017 for Non-Muscle Invasive Bladder ("NMIBC") cancer using its novel Photo Dynamic Therapy ("PDT") technology.http://theralase.com/pressrelease/theralase-pdt-technology-used-to-treat-first-patient-for-bladder-cancer/

Toronto, Ontario - March 15, 2017 Theralase Technologies Inc. ("Theralase®" or the "Company") (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that it has demonstrated 18 month long term stability of it lead anti-cancer Photo Dynamic Compound ("PDC"), TLD-1433.

http://theralase.com/pressrelease/theralase-demonstrates-18-month-stability-lead-anti-cancer-drug/

Toronto, Ontario - December 14, 2016, Theralase Technologies Inc. ("Theralase" or the "Company") (TLT: TSXV) (TLTFF: OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that it has released the video presentations conducted at the end of its Annual General and Special Meeting held on December 9, 2016 in Toronto, Canada. http://theralase.com/pressrelease/theralase-releases-agm-presentation-video/

Toronto, Ontario - October 28, 2016, Theralase Technologies Inc. ("Theralase®" or the "Company") (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical laser systems to eliminate pain and the development of light activated Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today an ability of its Photo Dynamic Therapy ("PDT") technology to increase survival by 925% in a very aggressive form of brain cancer, known as Glioblastoma Multiforme ("GBM"). http://theralase.com/pressrelease/theralase-increases-gbm-brain-cancer-survival-925/

Toronto, Ontario - October 20, 2016, Theralase Technologies Inc. ("Theralase®" or the "Company") (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that Health Canada has granted the Company Investigational Testing Authorization ("ITA") approval to use its patent pending TLC-3200 Photo Dynamic Therapy ("PDT") Laser System and TLC-3400 Dosimetry Fibre Optic Cage ("DFOC") technology, in conjunction with its Clinical Trial Application ("CTA") approved lead PDC, TLD-1433, to commence a Phase Ib clinical trial for the treatment of Non-Muscle Invasive Bladder Cancer ("NMIBC").

http://theralase.com/pressrelease/health-canada-grants-theralase-ita-approval/

Zack's Small Cap Research http://theralase.com/wp-content/uploads/2016/06/V.TLT_Zacks_Q12016_Update.pdf

http://scr.zacks.com/News/Press-Releases/Press-Release-Details/2016/VTLT--Theralase-Reports-Q2-2016-Financial-Results-Beats-Revenue-Estimates-By-More-Than-50/default.aspx

Osmium PDC ... For other types of brain cancers, apart GBM

There are 120 types of brain cancers. Looks like this Os PDC will be able to treat many of them.

"The latest published research supports the theory that Os PSs are well indicated to treat solid tumours, particularly when red or NIR light excitation is required to illuminate the entire tumour volume, such as brain cancers. Importantly, this is the first class of metal-based PSs that exhibit a direct panchromatic (activated by a wide spectrum of wavelengths) absorption from UV to NIR activation for PDT. For the first time, it may be possible to tune treatment depth to tumour invasion depth using a single PS, in which a single administration of the PS, followed by extended light administration (that could last several days) would enable the safest and most effective patient treatment outcomes."

The current GBM indication is currently using Ru based TLD-1433, as per this previous press release:

Theralase Increases GBM Brain Cancer Survival by 925% - Theralase ...

Oct. 28, 2016 - Theralase Increases GBM Brain Cancer Survival by 925% ...
treated by the laser activated Theralase PDC Rutherrin® (TLD-1433 + transferrin) ...

Theralase Demonstrates Significant Increase in Survival for Brain ...

Oct. 13, 2016 - NCI estimates that GBM accounts for 52% of all primary brain tumors ...
Rutherrin® comprised of TLD-1433 PDC (5 mg/kg) + transferrin

Read more at http://www.stockhouse.com/companies/bullboard/v.tlt/theralase-technologies-inc?postid=26087105#M46DYjqOjlDz7zux.99

Ph. 2b could end earlier, when looking at this example

Ph. 1b will set the tone for Ph. 2b.

Predictability and efficacy of TLT's PDT/PDC, thanks to the dosimetry software, will probably lead to outstanding results in the Ph. 1b.

If so, then Ph. 2b could be stopped earlier, because of statistically compelling numbers, just like we see a recent example in Oct. 2016.

PDT is much more precise and predictable than immuno-therapy drugs.
Our PDC has also demonstrated huge potentcy capabilities (98%+), and this, at low toxicity.
__________________

Take a look at this. You'll understand that we won't need much to beat immunotherapy that only deliver 6% of COMPLETE response (TLT got 98% in pre-clinical). Overall response = COMPLETE + PARTIAL responses.

UPDATED: Merck ends Keytruda trial early with data to challenge Opdivo in bladder cancer | FiercePharma

Oct 21, 2016

COPENHAGEN, Denmark--

Merck has cut short its Phase III trial of checkpoint inhibitor Keytruda in advanced bladder cancer, saying it hit its endpoint, and so is moving on to present the data to regulators. This is particularly good news for the drugmaker since it is playing catch-up to competitors Roche and Bristol-Myers Squibb for this condition.

The Kenilworth, NJ-based Merck said today that independent Data Monitoring Committee recommended ending the trial after the anti-PD-1 therapy met the primary endpoint of overall survival in patients with previously treated advanced urothelial cancer compared to chemotherapy using one of three treatments.

Merck is chasing rivals Roche and Bristol-Myers Squibb in bladder cancer, but now, it has some new data in hand showing its checkpoint inhibitor, Keytruda, could combat the disease as an up-front treatment for some patients.

Data on the first 100 patients in the Phase II Keynote-052 study--which enrolled 374 previously untreated bladder-cancer sufferers ineligible for cisplatin chemo--showed that 24% responded to the therapy. The patients' tumors shrank, regardless of their PD-L1 biomarker status, Merck said Saturday at the ESMO 2016 Congress. And 6% showed complete responses, exhibiting no detectable cancer after treatment.

It's a good sign for Merck, which is playing catch-up to rivals Roche and Bristol-Myers Squibb in the field. Roche's Tecentriq made its debut in bladder cancer in May, bursting onto the immuno-oncology scene with an FDA approval in patients who've failed on platinum-based chemotherapy. And at this year's ASCO meeting in June, Roche announced Phase II study data showing that 24% of cisplatin-ineligible bladder cancer patients saw their tumors shrink on Tecentriq.

Read more at http://www.stockhouse.com/companies/bullboard/v.tlt/theralase-technologies-inc?postid=26083248#9ZsRF5k2YVmJzR0L.99

Stockpick84 ... TLT's CEO mentioned that Big Pharmas won't force a buyout if the management is not interested to sell.

It's even more obvious when one invest so much G$$$ and that PDT/PDC is not its core business model. So TLT will be able to grow sales and that's a good thing before any official bidding war starts.

Last year, Sanofi tried an hostile 9G$ bid on Medivation and got burned. Offer was declined the next morning. Sanofi was then put aside from the next takeover discussions. Medivation, later opened up the bids to all big pharmas. Pfizer ended up winning this bidding war for 14G$.

Theralase would aim at much more bigger market size than Medivation. So no big pharma will risk the way of being eliminated right from the start, like it was the case for Sanofi in the Medivation example.

There's another recent case that is in line with this. Actelion was recently acquired by J&J for 30G$ only when Actelion owners were ready to sell. Couple of years ago, buy-out offers where turned down by these same owners. When they later decided they were ready to sell, they gave a signal to the industry.

Theralase will most probably allow different pharmas rights to our PDCs on specific cancer indications to capture interest. Then, when they will all understand that PDT/PDC is way more efficient and less costly than their own immuno-therapy drugs, bidding war will take place. In the meantime, some will probably team up with Theralase to fund for example a specific cancer indication (e.g. prostate, etc ...) or finance additional clinical trials (e.g. to officially displace BCG, for example, MIBC, etc ...) in exchange of rights.

That's the strategy Pharmacyclics (among others) used (working with many big pharmas) before putting itself for sale. Then 3 big pharmas ended up bidding. 2 offered 17G$, and Abbvie was the biggest bidder with 21G$.

That's why Theralase secured deep pockets on the last 2 private placements so that we could do some mileages to create shareholders value. These deep pockets are there to protect us from being bought for peanuts.

The fact that Theralase is aiming at the toughest solid tumour indications in 4 different fields o oncology (urology (bladder), pulmonary (lungs), dermatology (melanoma), neurology (brain)) will allow us to attract interest from many big pharmas to fund multiple cancer indications less tougher to beat.

Noticed by the way, that there's also a reason for TLT to have approved this rule, recently. Guess why;

Dec. 13, 2016 - Theralase Adopts Advance Notice By-Law
Read more at http://www.stockhouse.com/companies/bullboard/v.tlt/theralase-technologies-inc?postid=26082185#QZTTtfJU6YmZt1Li.99

RE:Keytruda new combinations ... Complete response = 15%

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bencro

March 09, 2017 08:30 pm

Incyte is worth 25G$ (185M TSO). With only 1 FDA drug approval and now in a jv with Merck.

Incyte (NASDAQ:INCY) Market Valuation History

Now, our little insecure whiners that cannot withstand the current 41M$ market valuation, should back track to June 2016 for a moment, in order to put things into perspectives.

That would allow them to appreciate the amazing opportunity that they have to be in a stock with such an amazing risk/reward ratio. Because with their combos, big pharmas don't even get close to the 12-months 31% complete response of Photofrin back in 1998. And TLT's CEO now owns a PDC that is 192x more potent (and less toxic) that Photofrin:


Incyte shrugs off trial failures with Merck PD-1/epacadostat tie-up

June 2016


It was a rough start to the year for Incyte ($INCY) when its JAK inhibition drug for solid tumors flopped in February, forcing the biotech to pull the plug on a slate of trials--which saw its shares nosedive (from 20G$ to 13G$).

But, shrugging off that disappointment, the biotech has picked itself back up and is getting in on one of the hottest tickets in oncology R&D right now--PD-1/PD-L1 checkpoint inhibitors--as it announces the start of its Phase III combo deal with Merck ($MRK).

The trial will see Incyte's experimental oral IDO1 inhibitor be used alongside Merck's marketed PD-1 Keytruda (pembrolizumab), as a first-line treatment for patients with advanced or metastatic melanoma. The study will now start after being announced back in December; data from the ECHO-301 study is set to be posted in 2018.

Keytruda gained FDA approval two years ago as a second-line treatment for patients with melanoma, the deadliest form of skin cancer, whose cancer has spread. Late last year, its label was updated so it could be used for the initial treatment of advanced melanoma patients.

"We are very pleased to treat the first patient in the ECHO-301 study and advance the Phase 3 program evaluating epacadostat in combination with pembrolizumab," said Steven Stein, Incyte's CMO, in a release. "This trial--the first to test this combination in a pivotal study--is part of the larger ECHO program evaluating epacadostat, including combination studies with anti-PD-1 and PD-L1 therapies across multiple tumor types."

More and more Big Pharmas are looking to combine their new checkpoint inhibitors with other classes of cancer drugs in an effort to further boost survival rates.

Pfizer, Merck, Roche, AstraZeneca, and Bristol-Myers Squibb are all combining with other companies and their experimental/marketed meds to see if they can boost the efficacy of their checkpoint inhibitors, with a slate of deals signed this year alone.

Merck was the first to market this new form of PD-1 checkpoint inhibitors, but it has fallen far behind fierce rival BMS in the sales stakes as its PD-1 offering Opdivo, despite being approved second, has stolen a march on Keytruda and now dominates market share.

Things also got a little tougher for Merck when Opdivo won a green light from the FDA at the start of the year for solo use in previously untreated patients, regardless of their BRAF status--putting it on par with Keytruda's license.

The Merck-Incyte Phase III trial is a randomized, double-blind, placebo-controlled study that will enroll 600 patients who will be stratified by PD-L1 expression and BRAF mutation status.

The two primary endpoints of the study are progression-free survival and overall survival, with key secondary endpoints including objective response rate, safety and tolerability.

Epacadostat is a first-in-class, selective oral inhibitor of the IDO1 enzyme that reverses tumor-associated immune suppression and restores effective antitumor immune responses.

In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma, according to Incyte (see attached data below (i.e the 15% COMPLETE RESPONSE)).

In these studies, the biotech said epacadostat, combined with BMS's melanoma CTLA-4 inhibitor Yervoy (ipilimumab), or Keytruda, improved response rates compared with studies of the immune checkpoint inhibitors alone. Ongoing Phase I and Phase II studies are investigating epacadostat in combination with PD-1 and PD-L1 inhibitors in a variety of other cancers.

Incyte will hope these trials will go well. Earlier this year Incyte stopped a range of studies for Jakafi as well as the experimental INCB39110, another JAK1. Already halted on one colon cancer trial failure, Incyte also ended the Phase III pancreatic cancer study, a separate midstage trial in colorectal cancer, a Phase II for breast and lung cancers and a dose-ranging trial for INCB39110 in pancreatic cancer.

The company, which markets Jakafi for polycythemia vera and certain forms of myelofibrosis in the U.S.--Novartis owns ex-U.S. rights to the drug--also got another boost today as the FDA granted a "breakthrough" designation this morning for Jakafi in patients with acute graft-versus-host disease--a condition with no currently approved treatments.

So as you can see, oncology market valuation will never be an issue for Theralase if we replicate even half of the pre-clinical destruction ratios. PDT/PDC would then shift immunotherapy drugs, both in terms of:

- efficacy
- cost
- duration of treament
- quality of care (less toxicity)

Human data will set the tone, in due time. In the meantime, even the latest immunotherapy combo cocktails are not much of a threat. Just a good thing for the moment for patients.

______________________________

Keytruda new combinations ... Complete response = 15%

To improve efficacy of its Keytruda blockbuster drug, Merck is now trying a combination with Incytes' epacadostat.

In a Phase 2 Advanced melanoma trial, this is the results it gave:

Merck Announces Initial Results for Pembrolizumab with Novel Immunotherapy combinations - Early Findings from the KEYNOTE-037 Study (Pembrolizumab with Epacadostat)

Nov. 21, 2015

Early data from this trial showed that in 19 patients with advanced melanoma, the combination of pembrolizumab (two doses studied - 2 mg/kg or 200 mg every three weeks) with epacadostat (four doses studied - 25, 50, 100 or 300 mg twice daily) demonstrated an ORR of 53% (n=10/19), including three (3) complete responses (NYSE:CRS) and seven (7) partial responses (PRs). The disease control rate (DCR) was 74 percent (n=14/19).

So complete response is around 15%. And overall (complete + partial) is around 53%.

On these results, Merck has decided to advance this combination to other cancer indications;

- advanced bladder
- lung (non-small cell lung cancer (NSCLC))
- head & neck

via this Jan. 2017 press release:


Incyte and Merck to Advance Clinical Development Program Investigating the Combination of Epacadostat with KEYTRUDA® (pembrolizumab)

So if Theralase replicates tumour destruction ratios anywhere close to clinical trials, we fly.
So whiners should do have done their homework a little bit more, instead of being insecure.

Disclosure: I am/we are long TLTFF.