Theralase Files US Patent Application for Increased Targeting of Photo Dynamic Therapy

Toronto, Ontario – January 20, 2015, Theralase Technologies Inc. (“Theralase”) (TLT:TSXV) (TLTFF: OTC Pink®) announced today that it has filed a provisional US patent application for “Transferrin Enhanced Photo Dynamic Therapy (“PDT”) Cancer Destruction” significantly increasing the targeting of its PDT technology; hence, also the efficacy and safety of the treatment.”

Transferrin is a substance that naturally occurs in the body (iron-binding blood plasma glycoprotein) that controls the level of free iron in our biological fluids. When transferrin encounters a transferrin receptor (“TfR”) on the surface of a cell, it is able to more effectively bind to that specific cell and delivery its payload, in this case Theralase’s lead Photo Dynamic Compound (“PDC”), TLD-1433.

Overexpression of transferrin receptors for a variety of cancers has been scientifically documented and is attributed to the malignant transformation of normal cells into cancer cells.

Theralase’s recent scientific research, which is the subject of this particular patent application, have demonstrated that Theralase’s lead PDC, TLD-1433, when combined with human transferrin, dramatically increases the targeting mechanism of TLD-1433 towards cells overexpressing TfR, primarily cancer cells; hence, further increasing the efficacy and safety of TLD-1433 in destroying these cancer cells.

Theralase’s research in PDT, the combination of a PDC and the laser light used to activate it, to produce cytotoxic (cell killing) oxygen species, has been previously demonstrated to be a promising avenue for minimally invasive localized cancer treatment.

Theralase’s lead PDC, TLD-1433, has demonstrated high efficacy and safety in cancer and bacteria destruction during preclinical in-vivo animal studies and due to this latest transferrin discovery may be further enhanced through specific binding and targeting of cancer cells.

Theralase’s latest scientific research has shown that TLD-1433 directly bound to transferrin results in significant enhancements of TLD1433’s biomedical properties and its efficacy in the destruction of cancer cells.

TLD1433 bound to transferrin results in the following ground breaking improvements:

• More than doubles the maximum tolerated dose of TLD-1433, resulting in greater payloads of TLD-1433 to cancer cells and thus higher efficacy


• Photobleaching (loss of efficacy) resistance and reactive oxygen species (PDC potency) production are both increased resulting in longer photoactivation of the PDC and higher efficacy due to an improved therapeutic ratio, resulting in increased cancer cell kill


• Increased absorption in green light resulting in higher efficacy and new absorption in the red and Near Infra Red (“NIR”) wavelengths resulting in greater efficacy at increasing tissue depths (ability to destroy deeper tumours)


• Reduced dark toxicity (cell kill in the absence of light activation) resulting in higher margins of safety for healthy tissues (higher therapeutic ratio)

Testing of TLD-1433 PDT efficacy in an in-vivo mouse model found that TLD-1433 bound to transferrin was able to increase the tumour free survival time of mice compared to TLD-1433 alone, at identical laser light exposures.

Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated that, “Our scientific research team was thrilled when they discovered that transferrin directly binds to TLD-1433 significantly improving targeting, efficacy and therapeutic outcomes in the destruction of cancer cells. We are excited to announce a major scientific discovery that leads to a marked improvement in the already high efficacy of our lead PDC, TLD-1433. TLD-1433 has recently been selected as the lead drug for a Health Canada Clinical Trial Application (“CTA”) / Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) application for Phase I / II a evaluation in a human clinical trial for Non Muscle Invasive Bladder Cancer (“NMIBC”).”

Dr. Lothar Lilge, Professor in the Department of Medical Biophysics, University of Toronto and Senior Scientist at the Ontario Cancer Institute, Princess Margaret Cancer Centre, University Health Network (“UHN”) stated that, “PDT of human cancer has traditionally been limited by the pharmacokinetics (path of a drug from the moment that it is administered up to the point at which it is completely eliminated from the body) of the PDC. The vast majority of Ruthenium based PDCs absorb in the blue-green light range, limiting their PDT effect to superficial cancers. Theralase has discovered that by pre-incubating their lead PDC, TLD-1433, with the human glycoprotein, transferrin, TLD-1433 mediated PDT efficacy is no longer limited by the PDC’s pharmacokinetics, as TLD-1433 directly binds to transferrin and thus greatly reduces the photo-bleaching of TLD-1433 when exposed to green light. Surprisingly TLD-1433 bound to transferrin strongly reduces the already low toxicity of TLD-1433 in-vivo enabling an increased safety for PDC mediated PDT. This decrease in toxicity in combination with lower photo-bleaching, results in higher TLD-1433 efficacy. We had already established TLD-1433 as a potent PDC for green light activated PDT; however, when bound to transferrin, TLD-1433 now has absorption in the red and Near Infra Red (“NIR”) light spectrums, opening up numerous new possibilities towards the destruction of cancers at larger distances from the light source.”

Dr. Lilge went on to say that, “These results place transferrin pre-incubation with TLD-1433 as a simple, novel, and potent way to improve selectivity towards a range of cancers, allowing them to accumulate a higher payload of TLD-1433 than previously achievable. This significantly increases the PDT specificity and destruction of cancer cells and at the same time the safety profile to healthy tissue, resulting in more effective cancer kill with virtually no impact to healthy tissue. The typically long lag times between laboratory discoveries and commercialization has been potentially shortened, as synthetic human transferrin is already in clinical trials. Its use here will assist in the further understanding of the discovery, as there may be more benefits other than improvements in the drug’s safety and efficacy profile. We are very encouraged by the success we have had with this very significant scientific discovery and plan to present the data at international scientific meetings this year.”

Roger Dumoulin-White, President and CEO of Theralase stated that, “This ground breaking discovery of combining naturally occurring transferrin with our PDCs will significantly increase the targeting of Theralase PDCs; hence a significant increase in efficacy and safety in the destruction of cancer. This will greatly increase our chances of success in the 2015 bladder cancer clinical studies slated for mid 2015; however, its utility does not stop here as it can also be applied to other non-Theralase metal based PDCs. This may open up additional opportunities pertaining to out-licensing the technology to large pharmaceutical companies that are currently manufacturing metal-based antibiotics and anti-cancer drugs.”

Quick timeline from my notes that we can complile/add to here if anyone has feedback. It was a good year,,, delays on TLC2000 but progress on pdc gmp and cro side as well as exciting invivo rat data. 2015 should be a fun year to study TLT news, progress/results and see where this might take us. This is forward looking. Study the science, the relevant markets, the team and company, make your own decisions whether it is worth grabbing a speculative position early or whether you need to see things unfold this year. Do your own DD!!

Approximate/Rough timeline:

• 4Q2014 TLT - Transition from TLC1000 to not yet released TLC2000 will likely see light 4Q2014 sales numbers as customers wait for new product


• 1Q2015 TLT - TLC2000 - Approvals - Hoping to see Regulatory approvals first quarter


• 1Q2015/2Q2015 TLT - TLC2000 - Launch - "Theralase will launch the patented, next generation TLC-2000 biofeedback therapeutic laser system in Canada in 1Q2015 and in the US in 2Q2015."


• 1Q2015 PDC - Optimization of the dose of laser light and PDC required in its orthotopic rat model to further refine this procedure for the destruction of bladder cancer in a live animal model.


• 1Q2015 PDC - Conduct Health Canada Clinical Trial Application ("CTA") / Food and Drug Administration ("FDA") Investigational New Drug ("IND") meetings


• 2Q2015 PDC - Complete pre-Good Manufacturing Practices ("GMP") and GMP manufacture of lead drug


• 2Q2015 PDC - Identification of toxicity laboratory and completion of toxicity analysis of the lead compound in 2 different animal species


• 2Q2015/3Q2015 TLT - Waiting to see TLC2000 sales data/traction


• 2Q2015/3Q2015 PDC - Health Canada and FDA CTA / IND Regulatory Approval for PDC treatment


• 3Q2015 PDC - Commence enrolling subjects into Health Canada / FDA Phase I / II a bladder cancer clinical study for NMIBC (Pending Regulatory Approval)


• 3Q2015 TLT - TLC2000 international sales targetted


• 3Q2015/4Q2015 - PDC - Trials commence - Treatments started


• 4Q2015 PDC - Twelve week followups starting in this period


• 1Q2016 - PDC- Final data compiled/ complete phase 1/2a bladder clinical trial - results submitted to FDA


• 2016 Waiting for FDA approval/feedback for fasttrack/commercialization


• New Drug Application (NDA)

Theralase believes they have a 99% chance of achieving Fast Track Status and after completion of a successful Phase 1/2a clinical trial over a 90% chance of achieving Breakthrough Status.

2016
(DOES Phase 1/2a trial demonstrate safety and efficacy and does treatment qaulify for Fasttrack??? YES=commercialization NO=Phase 2b)
YES = PDC approval-Commercialize PDC!
NO = FDA needs more data - 2016 - Commence Phase 2b (15M approx. cost if needed)

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Fasttrack?

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

-Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
-Avoiding serious side effects of an available therapy
-Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
-Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
-Ability to address emerging or anticipated public health need

A drug that receives Fast Track designation is eligible for some or all of the following:

-More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
-More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
-Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
-Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

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If Phase 1/2a goes according to plan and Fasttrack is requested and granted, we're pretty much moving forward with a new future and new timelines for commercialization and starting the next Cancer model. TLT has stated, that once bladder cancer treatment is approved they want to start their next cancer in 2016. They also have the bacteria PDC's that could open new doors and TLC3000 commercialization. If additional Phases for bladder were needed, that instead would be the focus of 2016 an on.

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http://www.accesswire.com/424706/Theralase-Summarizes-its-2014-Scientific-Achievements-and-2015-Strategic-Objectives

LINK

Toronto, Ontario / ACCESSWIRE / January 9, 2015 / Theralase Technologies Inc. ("Theralase") (TLT:TSXV) (TLTFF: OTC Pink(R)) announced today a summary of its 2014 scientific achievements published in peer reviewed, high impact scientific journals or presented at international conferences that detail its ongoing commitment to establishing the scientific and preclinical research required to support the launch of its cutting-edge technologies.

In addition, Theralase confirms its 2015 strategic objectives with anticipated timing.

From December 2013 to December 2014, the following peer reviewed papers have been published in high impact scientific journals or presented at international conferences and been globally recognized by the international scientific and medical community:

Photodynamic Inactivation of Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus with Ru(II)-based Type I/ Type II Photosensitizers (Photodiagnosis Photodynamic Therapy, 10(4):615-25, Dec. 2013)

Theralase's ability to destroy two types of bacteria (Staphylococcus aureus and Methicillin Resistant Staphylococcus aureus (MRSA)) up to 99.99999%, with a new class of Photo Dynamic Compounds ("PDCs") was considered pivotal by the international community because the PDCs were able to destroy two types of bacteria in both normal and low oxygenated tissue in nanomolar concentrations (micrograms of the PDCs were lethal to bacteria when light activated). The PDCs were proven especially effective in low oxygen environments, where certain types of bacteria and cancer are known to thrive.

Ru(II) Dyads Derived from ?-Oligothiophenes: a New Class of Potent and Versatile Photosensitizers for PDT (Coordination Chemistry Reviews, 282-283, 127-138, April 2014)

Theralase's new class of PDCs incorporates systems that act as dual Type I/II PDCs (able to work in oxygenated and non-oxygenated tissue), opening up the possibility of treating hypoxic (low oxygen) tumours with Photo Dynamic Therapy ("PDT"). These PDCs are remarkable in-vitro binders (localizing to organelles within the cell) and photocleavers (ability to destroy these organelles), leading to cell death, when light activated. They exhibit no damage to cells in the absence of light, supporting their high safety and tolerability. This PDT effect has been translated effectively to animals and has proven superior to FDA approved PDC Photofrin(R), in this research. The ability to activate the Theralase PDCs from visible to Near Infra Red ("NIR") light marks an unprecedented versatility that can be exploited to match treatment depth to tumour target depth, giving rise to PDCs for multi-wavelength activated PDT, that can target superficial as well as deep seated tumours.

In vitro Multi-Wavelength PDT with 3IL states: Teaching Old Molecules New Tricks (Inorganic Chemistry, 5;53(9):4548-59, May 2014)

Theralase's researchers demonstrated that Theralase's PDCs can be used for multi-wavelength PDT, as they are able to be activated by blue, green, red, and NIR light, allowing them to act as potent light-sensitive cytotoxic (cell killing) agents for cancer PDT applications in various depths of tissue.

Elicitation of Tumor-free Long-term Survival and Long-Lasting Antitumor Memory with Novel Non-Immunosuppressive Near-Infrared PDT (Presented at 37th Annual American Society for Photobiology, San Diego, California, June 2014)

Theralase researchers presented data that mice injected with 350,000 colon cancer cells (producing tumours approximately five millimeters in size) that were treated with an intra-tumoural injection of Theralase's lead PDC and illuminated by NIR light to activate the PDC produced results where a vast majority of the tumours were completely destroyed, with the PDC treatment demonstrating prolonged tumour regression.

In follow on research, the same mice who received the initial, successful PDT were re-injected with the same number of colon cancer cells, 13 to 23 days later. With no further treatment intervention, mice in these experiments, demonstrated either a small tumour regrowth, which quickly regressed, or in the majority of animals, no tumour regrowth at all, suggesting a short-term immune-mediated (immune "memory response") tumour rejection.

To further prove the resilience of the PDT treatment, these same animals were then injected a third time with an additional 350,000 colon cancer cells at ten months post PDT treatment. None of these animals showed any sign of tumour regrowth, even at 3 months post follow up, suggesting the presence of a long-term anti-tumour immunity, responsible for complete tumour rejection.

To strengthen the data, control experiments were conducted where age matched mice without prior tumour exposure or PDT treatment were injected with the same number of colon cancer cells, where the majority of these mice proceeded to develop tumours and did not survive more than 1 month following the injection.

In November 2014, the initial data was further validated showing that mice who received the initial, successful PDT were re-injected with an equal number of colon cancer cells, 20 days later. With no further treatment intervention, 100% of the mice in these experiments demonstrated 0% tumour regrowth, suggesting an optimization to the short-term immune-mediated (immune "memory response") tumour rejection.

The initial results have now been validated and optimized by Theralase researchers with a new set of animals confirming the immune-mediated (immune "memory response") tumour rejection. This anti-cancer memory response suggests a major breakthrough in cancer research and may provide substantial treatment benefit and survival advantage to cancer patients. Technology that is able to rapidly and effectively destroy "patient-specific" cancer cells, prevent their recurrence and provide long lasting protection against local and distant metastasis, offers immense clinical benefit to cancer patients and the facilities that treat their disease.

Ru(II) Dyads Derived from 2-(1-Pyrenyl)-1H-Imidazo[4,5-f][1,10] Phenanthroline: Versatile Photosensitizers for Photodynamic Applications (Journal of Physical Chemistry, 13;118(45):10507-21, November 2014)

Theralase researchers demonstrated that their new class of PDCs exhibited nanomolar (micrograms of PDCs) light cytotoxicities (cell kill) against cancer cells. This potency extended to bacteria. The results from this study demonstrate the versatility of these highly potent photosensitizers in destroying both cancer and bacterial cells and expand the scope of compounds that utilize low-lying states for photobiological applications.

Roger Dumoulin-White, President and CEO of Theralase stated that, "I am pleased that our research scientists have been able to accomplish such dramatic milestones in our scientific and preclinical research in 2014. I am confident that 2015 will bring even more dramatic advances in both our Therapeutic Laser Technology ("TLT") and Photo Dynamic Therapy ("PDT") Anti-Cancer Divisions", as we progress our leading technologies to market.

In 2015, Theralase plans to execute on the following strategic objectives:

In the TLT Division, Theralase will launch the patented, next generation TLC-2000 biofeedback therapeutic laser system in Canada in 1Q2015 and in the US in 2Q2015. Theralase had anticipated launching the TLC-2000 in 4Q2014, but due to increased testing and regulatory requirements brought on by new international testing standards, launch was slightly delayed to allow the Company time to complete its mandatory regulatory testing.

In the PDT Division, Theralase will commence clinical testing of its lead PDC in humans via a Health Canada / FDA Phase I / II a bladder cancer clinical study for Non Muscle Invasive Bladder Cancer ("NMIBC") in 2015.

Strategic objectives in 2015 to accomplish this task include:

• 
  

  -- Optimization of the dose of laser light and PDC required in its orthotopic rat model to further refine this procedure for the destruction of bladder cancer in a live animal model. Preliminary results reported in 4Q2014 were excellent demonstrating: localization of the PDC to bladder cancer tumours, destruction of bladder cancer upon light activation, no impact to healthy bladder tissue during treatment and a very high safety profile, evidenced by virtually no PDC being absorbed into the blood stream (1Q2015)

  
  

  - Conduct Health Canada Clinical Trial Application ("CTA") / Food and Drug Administration ("FDA") Investigational New Drug ("IND") meetings (1Q2015)

  
  

  - Complete pre-Good Manufacturing Practices ("GMP") and GMP manufacture of lead drug (2Q2015)

  
  

  - Identification of toxicity laboratory and completion of toxicity analysis of the lead compound in 2 different animal species (2Q2015)

  
  

  - Health Canada and FDA CTA / IND Regulatory Approval (2Q2015)

  
  

  - Commence enrolling subjects into Health Canada / FDA Phase I / II a bladder cancer clinical study for NMIBC (Pending Regulatory Approval)

  
  

About Theralase Technologies Inc.

Founded in 1994, Theralase Technologies Inc. ("Theralase(R)") (TSXV: TLT) (TLTFF: OTC Pink(R)) designs, manufactures and markets patented super-pulsed laser technology used for the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing. Theralase has sold over 1,200 systems to licensed healthcare practitioners, including: medical doctors, chiropractors, physical therapists and athletic therapists. Theralase has been so successful in healing nerve, muscle and joint conditions in clinical practice that Theralase's scientists and clinicians have now turned their attention to investigating the application of its lasers in the destruction of cancer. Using specially designed molecules, Theralase uses Photo Dynamic Compounds ("PDCs") to localize inside the cancer cells and when light activated, destroy them.

Additional information is available at www.theralase.com and www.sedar.com .

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.

For More Information:

Roger Dumoulin-White

President & CEO, Theralase Technologies Inc.

1.866.THE.LASE (843-5273) ext. 225

416.699.LASE (5273) ext. 225

rwhite@theralase.com

www.theralase.com

TLT rallied to .56 in Feb2014,,,, then in a typical summer dwindle with not too many catalysts... and along with a 4 month holding period expirey from the 2013 financing, was dragged down to around .21 in May2014, pretty much as expected. It ran .2x to .3x from May to Dec2014 where many of us accumulated as the science and catalyst came closer to a tipping point. Mid Dec2014, the rat invivo results were priced in before official news came spiking to .78... two things happened.. you had organized selloff on news typical of the junior venture exchange... I think without the venture manipulation, we'd be over a $1 by now... it is what it is... so now we have our pullback.

Many of us believe we should see new support and resistance levels, a trading range of .55 to .75 established but hopefully an uptrend can be manintained with the right catalyst/timing/results/exposure. Perhaps a pullback to .38 but .45 might be a new bottom but where it goes from here could be a large upside, we believe this last year when we couldn't crack out of the .3x's and we believe it now. There have been a lot of warrants excercised which is a positive... some at .2 and .38's. Once these are all gone (soon) and all the new long positions are holding shares tightly, I expect 2015 to be a great year.