Theralase Advanced Cancer Therapy Research Recognized at Major International Conference

Toronto, Ontario – May 16, 2013, Theralase Technologies Inc. (TSXV: TLT) (“Theralase”) announced today that its researchers have discovered a significant new mechanism of action for a new class of Photo Dynamic Compounds (PDCs), that have been custom designed to destroy cancer cells when activated by a proprietary light source.

The preclinical study, conducted by Theralase scientists and their colleagues at University Health Network’s Princess Margaret Cancer Centre, was presented on May 15, at the Laser World of Photonics conference held in Munich, Germany.

In previous preclinical studies, Theralase’s PDCs have been proven to be promising anti-cancer agents in various cancer models. Their efficacy involved a number of critical cellular processes, including DNA damage and programmed cell death. All PDCs were thought to work primarily by oxygen-dependent mechanisms, ultimately causing cell death in the presence of highly reactive oxygen. In this study; however, scientists established that a new class of Theralase PDCs have an additional “oxygen independent” mechanism of action, which would increase efficacy in the destruction of more clinically aggressive tumours.

The research lead by Dr. Lothar Lilge, Senior Scientist, Ontario Cancer Institute, Princess Margaret Cancer Centre and Dr. Arkady Mandel, Chief Scientific Officer, Theralase has shown that specific metal-based PDCs when tested for effectiveness of cancer destruction in a low oxygen environment were proven to be highly effective in the destruction of human brain cancer cells in-vitro, thus activating this newly discovered pathway. Additionally using this pathway, Theralase scientists confirmed in a preclinical model a complete response rate and the destruction of subcutaneous (under the skin) colon cancer tumours in mice, which were treated with Theralase’s anti-cancer PDC technology. On follow-up, the initial complete response was maintained in two-thirds of the animals for over 1 year without recurrence.

Roger Dumoulin-White, President and CEO of Theralase Technologies Inc. stated, “Recognition of our world class anti-cancer research at the Munich conference is another testament to the cutting edge research our scientists are conducting in this field. Our findings would strongly suggest that Theralase’s PDCs oxygen independent potency would significantly enhance our ability to destroy cancer cells. Tumours in a low oxygen environment have been extremely challenging because this lack of oxygen renders solid tumours much more resistant to therapeutic interventions. Many traditional therapeutic agents, conducted on poorly oxygenated solid core tumours, including any currently FDA approved PDCs, are susceptible to a “self-limiting” activity; whereby, below a critical threshold oxygenation level, their efficacy is progressively reduced resulting in minimal to no cancer cell destruction. This new class of Theralase PDCs are not susceptible to this “self-limiting” activity and as a result maintain their efficacy even in extremely low oxygenated cancerous tumours, such as breast and prostate cancer. As a result, Theralase is extremely excited about the latest research and what it means in the field of cancer destruction. Theralase is committed to the early commercialization of its patented light activated Photo Dynamic Compounds in the areas of anti-cancer and anti-bacterial applications to generate substantial revenues for the Company and hence dramatically increase shareholder value.”

About Theralase Technologies Inc.

Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions Theralase is currently developing patented Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase’s proprietary laser technology.

For further information please visit www.theralase.com , regulatory filings may be viewed by visiting 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, please contact:

Roger Dumoulin-White,                                                                      

President & CEO                                                                                  

416-699-LASE (5273) ext. 225                                                              

rwhite@theralase.com

Kristina Hachey

Chief Financial Officer

416-699-LASE (5273) ext. 224

khachey@theralase.com                                                                     

Greg Bewsh

Director of Investor Relations

416-699-LASE (5273) ext. 258

gbewsh@theralase.com  

Arkady Mandel

Chief Scientific Officer

416-699-LASE (5273) ext. 260

amandel@theralase.com

Theralase Achieves Commercialization Milestone For Its Bladder Cancer Therapy

Toronto, ON -- March 14, 2013 -- Theralase Technologies Inc. (TSXV: TLT) announced that its proprietary Photo Dynamic Compound (PDC) technology has been approved for use in a live animal bladder cancer model by the University Health Network (UHN) Research Ethics Board. This approval expedites the Company’s progress towards commercializing its advanced bladder cancer therapy.

Theralase’s leading proprietary oncology PDC has repeatedly demonstrated that it is:

• toxic to bladder cancer cells when light activated (100% kill rate)
• exceeds potency of FDA approved PDCs   
• highly stable ensuring optimal tumour destruction

Theralase will validate its PDC technology in this animal cancer model to support an Investigational New Drug (IND) application to be filed with the FDA later this year. This IND application will allow Theralase to commence a Phase 1/2a human clinical trial to prove the safety and efficacy of its PDC technology on a 30 subject population with scheduled completion in 2014. Based on recent pharmaceutical acquisitions for oncology drugs and market statistics, the estimated value of the PDC upon successful completion of a FDA Phase 1/2a clinical trial ranges from $84 million to $360 million in upfront payments followed by a double digit revenue royalty stream. (Source: BIO statistics)

Arkady Mandel MD, PhD, DSc, Chief Scientific Officer of Theralase Technologies Inc. stated, “Protocols and standard operating procedures are in place to ensure adherence to the highest scientific and ethical standards. In addition, the program has been fully accredited by the Canadian Council for Animal Care. This critical research is a vital progressive step that will greatly advance our innovative bladder cancer therapy.”

Michael Jewett, FRCSC, MD, an eminent urologist and a member of the Department of Surgical Oncology at UHN’s Princess Margaret Cancer Centre, as well as a member of Theralase’s Medical and Scientific Advisory Board said, “The elements of Theralase’s PDC development plan are in place and I believe they will lead to a successful FDA Phase 1/2a human clinical bladder cancer trial to commence early next year. With a recurrence rate of nearly 80%, bladder cancer is the most expensive cancer to treat on a per patient basis and raises many issues affecting the quality of life because of its persistence.”

Roger Dumoulin-White, President and CEO of Theralase Inc. stated, “Our leading PDC drug candidate has been proven to be superior to any currently approved FDA PDC on the market. As we continue to achieve our critical research milestones, Theralase’s leading PDC provides indisputable proof of its efficacy in the destruction of cancer in live animal models. Subject to a successful FDA Phase 1/2a human clinical bladder cancer trial of the PDC technology, Theralase will apply for “breakthrough status” with the FDA, which if granted, would allow Theralase the unique opportunity of commercializing its technology without the need for further FDA clinical trials, thus allowing the bladder cancer technology the most direct route to fulfill an unmet medical need and aid in the destruction of a deadly disease.”

About Theralase Technologies Inc.:

Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing. Theralase is currently developing patented Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technology.

 For further information please visit www.theralase.com , regulatory filings may be viewed by visiting 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                    

416-699-5273 ext. 225                                  

rwhite@theralase.com 

Theralase Compound Effective in Destroying Bladder Cancer Tumour Cells

Toronto, Ontario –November 12, 2012 -- Theralase Technologies Inc. (TSX-V: TLT) Photo Dynamic Therapy (PDT) Division, announced today study results proving that its patented Photo Dynamic Compounds (PDCs)  were significantly more effective in destroying a human urinary bladder carcinoma cell line than a FDA approved photosensitizer, aminolevulinic acid (ALA).

Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated, “Commercialization of any new anti-cancer medicine depends upon the safe and effective destruction of all cancerous tumours, while upholding the patient’s quality of life. We are excited that our leading compound effectively destroyed a human urinary bladder carcinoma cell line (HT-1376) when activated by our proprietary light system. To validate our initial success, we evaluated the efficacy of the Theralase PDC in comparison with aminolevulinic acid (ALA). The results indicated that the Theralase PDC was effectively destroying bladder cancer cells at much lower concentrations than ALA (1/1000^th of the dose).”

Dr. Lothar Lilge, Professor and Senior Scientist, Ontario Cancer Institute, Princess Margaret Cancer Centre, University Health Network stated, “In my lab, the Theralase PDCs have shown remarkable efficacy and robustness in the destruction of various cancer cell lines, such as: colon, brain, breast and now bladder cancer. This research potentially offers a new opportunity for individualized cancer therapy across various invasive tumours.”

Roger Dumoulin-White, President and CEO, Theralase Inc. stated, “Based upon our recent success, we have now reconfirmed that bladder cancer is our lead cancer target for our lead PDC compound. Our research confirms what we had already suspected; our PDC technology is lethal to human urinary bladder carcinoma cells. Given that our technology can deliver effective results at significantly lower doses than ALA, this would suggest a superior safety and cost effectiveness for our lead compound, as compared to ALA. We are confident that as we complete our preclinical research and prepare for human trials in 2013, we will demonstrate to the medical community that we possess a highly effective, safe and efficient alternative treatment option to current bladder cancer patients.”

Bladder cancer is the fifth most common cancer in the North America; the fourth most common among men and eighth most common in women. In the United States 73,000 new bladder cancer cases and 15,000 deaths are reported annually. With a recurrence rate of nearly 80%, bladder cancer is the most expensive cancer to treat on a per patient basis. The high recurrence rate severely affects the quality of life of patients and also the total cost of treatment, which in the United States exceeds $2.9 billion in direct treatment related costs annually.

In other related news, Sun Pharmaceutical Industries (NSE: SUNPHARMA, BSE: 524715), with a market value of $USD 13.3 billion, announced on November 8, 2012, that it signed a definitive agreement to acquire Dusa Pharaceuticals Inc. (DUSA) for $8 per share for a total cash consideration of $USD 230 million. DUSA is a dermatology company focused on developing and marketing its FDA approved Levulan photodynamic therapy platform (active ingredient of Levulan is ALA), for actinic keratosis of the face or scalp (dry, scaly patches on the skin that can lead to skin cancer). http://www.sunpharma.com/news/press/20121108%20Sun%20Pharma%20to%20Acquire%20DUSA%20.pdf

About Theralase Technologies Inc.:

Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing. Theralase is currently developing patented Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technology.

 For further information please visit www.theralase.com , regulatory filings may be viewed by visiting 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                         

416-447-8455 ext. 225                                          

rwhite@theralase.com

Kristina Hachey

Chief Financial Officer

416-447-8455 ext. 224

khachey@theralase.com 

Arkady Mandel

Chief Scientific Officer

416-447-8455 ext. 242

amandel@theralase.com

Greg Bewsh

Director of Investor Relations

416-447-8455 ext. 262

gbewsh@theralase.com   

Theralase Photo Dynamic Compounds Destroy Cancer

Toronto, Ontario – October 22, 2012, Theralase Technologies Inc. (TSX-V: TLT) announced today the successful results of preclinical studies (in-vitro and in-vivo) demonstrating significant destruction of various brain and colon cancer cell lines. The new proprietary Theralase treatment sharply delayed the tumour progression, when attacked by the Theralase patented light activated Photo Dynamic Compounds (PDCs), signifying a new and broadly promising approach to cancer treatment. When treated with the Theralase PDCs, cancerous mice survived cancer-free for more than 100 days post-treatment, a highly significant milestone.

The scientific data supporting this breakthrough was presented and well received recently at the 9th International Symposium of Photodynamic Therapy and Photodiagnosis in Clinical Practice held in Brixen, Italy. The Theralase presentation was made by Dr. Lothar Lilge, Senior Scientist, Ontario Cancer Institute / Princess Margaret Cancer Centre, University Health Network (UHN) and confirms the significance of the successful research conducted by Theralase in collaboration with UHN scientists, validating this scientific work on the international stage.

Dr. Lothar Lilge stated that, "These preclinical results demonstrate that the Theralase Photo Dynamic Compounds appear to be highly effective (100% cancer cell kill) when used to destroy various cancer cell lines in-vitro; specifically, brain glioma (U-87 and F-98) and in-vivo; specifically, colon cancer (CT-26WT), in the treatment of subcutaneous cancer tumours in Balb/c mice. Mice enrolled in the study, presented with subcutaneous cancerous lesions of approximately 6 mm in size prior to treatment, which is standard for these preclinical models. The statistically significant improvement in survival times make these results even more encouraging, as a number of mice are still alive today living cancer free, 100 days post treatment. Moreover, we believe that tested PDCs may have potential for Type I (oxygen independent) PDT effect; hence, their clinical use would represent a significant gain in cancer therapy.”

Dr. Arkady Mandel, Chief Scientific Officer at Theralase Inc. stated that, "We were delighted with the extremely promising results of our latest cancer studies, which demonstrate significant anticancer destruction of Theralase’s PDCs in all tested in-vitro studies and  in difficult to treat in-vivo cancer models, without significant optimization. With optimization, the ability of the Theralase PDCs to target and destroy cancerous tumours could be even more enhanced. There are a number of obvious advantages for the use of Theralase’s PDCs in the destruction of cancer that have been established by this body of work, such as: the Photo Dynamic Therapy (PDT) effect has been achieved at lower concentrations compared to aminolevulinic acid, also known as ALA (ALA is a currently approved FDA PDC) and with lower dark toxicity (PDC alone with no light) compared to methylene blue (another PDC), the Theralase PDCs have potential for Type I (oxygen independent) PDT effect and lastly were able to induce tumour necrosis (cell death) in mice that allowed prolonged survival, cancer free, in excess of 100 days of observation. New evidence from experimental and clinical studies increasingly points to a lack of oxygen content or hypoxia in solid tumours to be strongly associated with tumour propagation, malignant progression and resistance to therapy and it has thus become one of the central issues in tumour physiology and cancer treatment. Therefore, with the latest scientific data in hand, Theralase’s PDT has the potential to become more expeditiously integrated into the mainstream of cancer treatment.”

Roger Dumoulin-White, President and CEO of Theralase stated, “This new research extends the opportunity of Theralase’s patented PDC technology to have a successful impact on two additional devastating forms of cancer; specifically, brain and colon cancer. Our research has demonstrated a kill rate of effectively 100% in specific human brain and colon cancer cells lines. With the high mouse survival rate, which is approximately equivalent to 11 years “cancer free” in humans, being observed in this study, these results lay the groundwork for further preclinical work for these specific cancers. If the preclinical work is proven successful, this would lead to human clinical trials as early as 2013. Theralase plans to aggressively pursue commercialization of its ground-breaking PDT technology through the FDA regulatory approval process and is on track to commence FDA Phase 1 human clinical trials as early as this time next year. Theralase plans to continue its research and development at an accelerated pace to optimize and expand its growing patent portfolio of PDCs that are able to destroy a variety of life threatening cancers.”

About Theralase Technologies Inc.:

Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing. Theralase is currently developing patented Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technology.

 For further information please visit www.theralase.com , regulatory filings may be viewed by visiting 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,                       

416-447-8455 ext. 225                                          

rwhite@theralase.com

Kristina Hachey

Chief Financial Officer

416-447-8455 ext. 224

khachey@theralase.com 

Arkady Mandel

Chief Scientific Officer

416-447-8455 ext. 242

amandel@theralase.com

Greg Bewsh

Director of Investor Relations,

416-447-8455 ext. 262

gbewsh@theralase.com