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 

Renowned Oncologist Dr. Michael Jewett Joins Theralase’s Medical and Scientific Advisory Board

Toronto, Ontario –January 29, 2013 -- Theralase Technologies Inc. (TSX-V: TLT) is pleased to announce that effective January 15, 2013, Michael Jewett MD, FRCSC, FACS has elected to join its Medical and Scientific Advisory Board.

Dr. Michael Jewett is currently a Professor of Surgery in the Division of Urology at the University of Toronto, a member of the Department of Surgical Oncology at Princess Margaret Cancer Centre and of the Division of Urology at the University Health Network. He is well known for his contributions in the fields of technology assessment and image guided therapy, especially for minimally invasive treatment of kidney and bladder cancer. He is internationally known for his contributions in the fields of bladder, testis and kidney cancer fundamental and clinical research. For his valued contributions to the uro-oncology field, in 2008, Dr. Jewett was awarded the Wyeth/CIHR Rx&D Clinical Research Chair in Oncology. He also holds the Farquaharson Chair for Kidney Cancer Research.

Dr. Jewett has been the Principal Investigator/Co-Principal Investigator on over 60 Phase I-Phase III clinical trials and the Lead Principal Investigator of several Cooperative Group Trials. These clinical trials have primarily been focused on proving the safety, efficacy and clinical benefits of technology in the destruction of cancer, with the ultimate gain of achieving Health Canada or FDA clinical approval. 

He has recently served as Chairman of the Division of Urology at the University of Toronto and of Urology at the University Health Network, which incorporates the Princess Margaret Cancer Centre, one of the world's leading cancer centres. He is a recent Past-President of the Canadian Urology Association and a member of many urological and surgical oncology societies; including the Scientific Advisory Board of the Bladder Cancer Advocacy Network, the Medical Advisory and Research Board of Bladder Cancer Canada, and Chair of the CIHR funded Kidney Cancer Research Network of Canada. Dr. Jewett has been recognized for his lifetime achievements and contributions to Urology by the Canadian Urological Association, the American Urological Association, the Societe Internationale d’Urologie and the Society of Urologic Oncology.

Dr. Jewett stated, “I have been very impressed with the expertise of the Theralase team and with the significant opportunity their Photo Dynamic Compounds (PDCs) present in the field of bladder cancer treatment. I look forward to working with them closely in their quest to commercialize their PDC technology to the ultimate benefit of bladder cancer patients, when the unmet need remains so great”.

Roger Dumoulin-White, President and CEO, Theralase Technologies Inc. stated that, “We are elated to have someone of Dr. Jewett’s calibre join Theralase’s Medical and Scientific Advisory Board to lead our bladder cancer clinical research program. He has been actively engaged in clinical cancer research and will prove to be an invaluable resource for helping to design our clinical protocols, in conjunction with our research team, as we focus on our lead target, bladder cancer. With Dr. Jewett’s expert guidance, we are confident that we will be able to complete the steps necessary to commence FDA Phase 1 human clinical trials in 2013 with our lead Photo Dynamic Compound (PDC), where we will demonstrate that Theralase possesses a highly effective and safe alternative treatment option to patients, suffering from non-muscle invasive bladder cancer. Based on the clinical success of the PDC technology in FDA Phase 1 human clinical trials, Theralase is expected to be granted FDA “Fast Track” designation allowing an expedited priority review and approval process.”

According to the FDA, “Fast Track” is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

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                    

416-694-7246 ext. 225                                  

rwhite@theralase.com

Kristina Hachey

Chief Financial Officer

416-694-7246 ext. 224

khachey@theralase.com 

Arkady Mandel

Chief Scientific Officer

416-694-7246 ext. 242

amandel@theralase.com

Greg Bewsh

Director of Investor Relations

416-694-7246 ext. 262

gbewsh@theralase.com   

Theralase Creates Two Operating Divisions

Toronto, Ontario – August 16, 2012, Theralase Technologies Inc. (TSX-V: TLT) announced today that it is reorganizing its operations into two separate reportable operating divisions to better service and focus the company’s resources for both independent markets. The Therapeutic Laser Technology (TLT) division will be responsible for all aspects of the Company’s burgeoning therapeutic laser business, which manufactures products used by healthcare practitioners predominantly for the healing of pain and the Photo Dynamic Therapy (PDT) division, which researches and develops Photo Dynamic Compounds (PDCs) for the destruction of primarily cancer.

Roger Dumoulin-White, President & CEO of Theralase Technologies stated that “It has become evident through the recent successes of both technology platforms that these two operating divisions have unique requirements in terms of financing, staffing, logistics and resource allocation. Our intent is to manage and focus the direction of each division to better execute on their respective strategic objectives. Our therapeutic laser products have been recognized by independent health care practitioners worldwide as “best-in-class” in terms of safety, efficacy and overall clinical performance. In terms of market size, it has been reported by the American Pain Association that health care expenses, lost work time and reduced productivity due to pain, costs the US medical system approximately $100 billion annually. In order to help alleviate their pain, Americans consume annually in excess of $20 billion of pain medications and according to a recent study 42% felt that pain medications were ineffective in relieving their pain, allowing a minimum $8.4 billion annual market opportunity for Theralase. Our corporate mandate is to capture less than 1% of this underserved market achieving annual revenues of $50 million in a recurring revenue model within the next 5 years. Theralase intends to capitalize on this market through the direct sales, marketing and international distribution of our growing platform of laser technologies; including our flagship TLC-1000 product and soon to be released TLC-2000 product”.

Mr. Dumoulin-White added, “In the current decade, oncology has been one of the most important growth segments among the biotechnology and pharmaceutical markets. The global cancer drug market alone is expected to surpass $US78 billion in 2012. Theralase has recently made significant advances in the research and development of its  novel  patented Photo Dynamic Compounds (PDCs) in terms of cancer destruction that are laying the groundwork for Health Canada and FDA Investigational New Drug (IND) applications, anticipated to be submitted in 2013. The potential market for our advanced PDT technology platform for the first targeted clinical indication of bladder cancer in the US alone is over $3.5 billion annually. Our mandate is to partner the PDC technology after FDA Phase 2 clinical approval, expected within the next 3 to 5 years and to successfully negotiate a royalty agreement for the worldwide distribution of this technology, commencing immediately after formal regulatory Health Canada and FDA approval, expected within the next 5 to 7 years.  Due to the lack of clinical research and advances in the field of bladder cancer treatment over the last 16 years, Theralase is confident that our advanced PDC approach could quickly gain sizable market share with the right pharma partner in this underserved market. Our mandate is to capture 10% of this market with our pharma partner and through royalty revenue generate recurring revenue in excess of $50 million annually.”Mr. Dumoulin-White concluded by stating that, “Theralase’s mandate is to build both the TLT and PDT divisions into separate $50 million annual recurring revenue models within the next 5 to 7 years.”

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 tissue healing in both humans and animals. Theralase also develops patented Photo Dynamic Compound (PDC) technology focused at targeting and destroying cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technologies.

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            

Greg Bewsh

Director of Investor Relations,

416-447-8455 ext. 262

gbewsh@theralase.com      

Quest for a wonder drug started with shrew bait

First, he lured shrews into his backyard with No Name-brand pepperoni. Then, he extracted their venom-laced saliva.
Now Jack Stewart, a Sackville, N.B.-based biochemist-turned-biotechnology entrepreneur, is about to start a human trial for a drug developed from a compound found in shrew spit that could treat ovarian, breast and prostate cancers without many of the side effects of chemotherapy.
It’s an unusual discovery – others knew the saliva had paralytic properties and Dr. Stewart had originally hoped to develop a pain medication. But when he studied the compound in the spit more closely, he found potential cancer-fighting qualities.
Like all new drugs bearing the weight of great expectations, Dr. Stewart’s shrew-saliva spinoff faces long odds. Health Canada and the U.S. Food and Drug Administration (FDA) set a high bar for approval. The cost of executing clinical trials can be prohibitive, and even if a medicine does reach the market, the competition from other drugs is fierce.
“Starting from a drug conceptually that’s entering preclinical testing in an animal model and following that through to a licensed drug, the fall-off is considerable,” said Ralph Meyer, director of the National Cancer Institute of Canada’s clinical trials groups.
But the novelty of the source of the drug – called soricidin, the compound found in the shrew saliva – and the fact that it could treat three types of cancers has been enough to take Dr. Stewart to this stage. In a few weeks, his company, Soricimed Biopharma Inc., plans to start its first clinical trial on patients in the United States and Canada. There are three phases of human trials, each more rigorous – and expensive – than the last.
Dr. Stewart hopes the trial will prove his drug is a viable alternative to chemotherapy. Unlike chemo, which takes a carpet-bombing approach and kills healthy cells along with cancerous ones, soricidin works in a slower, less destructive way, he said.
Ovarian, breast and prostate cancers produce high numbers of a certain type of calcium channel that feed calcium to cancer cells and allows them to proliferate. The soricidin works to plug the calcium pipeline, which eventually leads to death of the cancer cells.
“It’s a resetting of the cancer cell rather than a poisoning of it,” Dr. Stewart explained. “We leave it to the cancer cell to kill itself.”
Simply getting the soricidin was a challenge, Dr. Stewart said. He tried everything from peanut butter to seeds to trap shrews in his backyard, all of which failed. One morning, though, his traps were filled with the critters. It turns out discount pepperoni brings all the shrews to the yard.
Since Dr. Stewart said there are “not enough shrews on the planet” to produce sufficient soricidin for his trials, his team developed a synthetic, which was used during animal testing and will soon be administered in human trials.
While Soricimed celebrates reaching the human-trial stage, it has many obstacles to clear before its drug can reach the market.
From 2004 to 2011, only 6.7 per cent of the oncology drugs that made it to the first phase of clinical trial were eventually approved by the FDA for sale, according to data tracked by the Biotechnology Industry Organization, a Washington-based trade association. For all other drugs, the approval rate was nearly double.
“It’s difficult to structure and run [oncology drug] trials with clear, robust criteria for success,” said Veronika Litinski, a senior adviser in life sciences and health-care practice at the MaRS Centre in Toronto.
With HIV drugs, she says, researchers look at the viral load before and after the drug is administered – the results are easily measurable. Whereas in cancer drug testing, they rely on survival rates. Did the drug extend the life of a patient by a few months? A year? What was the quality of life for the patient during that year? Did the side effects offset the benefits?
Even if its first trial is a success, Soricimed will need to round up cash to proceed with more trials since it has only raised $11-million so far through private investors and federal government programs.
The anticipated cost of the first human trial is $2.5-million, said Paul Gunn, Soricimed’s chief executive officer. For phase 2, the company will have to shell out anywhere between $4-million and $40-million. The third trial could come with a price tag of more than $100-million.
The small company hopes to partner with a larger pharmaceutical or biotech company after phase 1, Mr. Gunn said.
Even if soricidin were approved by Health Canada or the FDA, it would still face an array of challenges. The way a drug is marketed, the competition it faces and the willingness of provincial health authorities to fund it all play into how well a new medicine does.
“[Soricimed] has cleared a lot of hurdles to get to phase 1,” Dr. Meyer said, “but they still have a lot to get through.”