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Isotechnika's Lead Immunosuppressive Drug, ISA247 Positioned to Enter Phase II/III Clinical Trials for Uveitis by its Partner Lux Biosciences
Edmonton, Canada, November 28 (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) today announced that its lead immunosuppressive drug, ISA247 is positioned to enter Phase II/ III human clinical trials in uveitis by its partner Lux Biosciences, following interactions with the Food and Drug Administration and clearance of its Investigational New Drug Application (IND).
On May 25 of this year, Isotechnika signed an agreement with Lux Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences exclusive, worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247 for the treatment and prophylaxis of all ophthalmic diseases.
ISA247, which is referred to as LX211 by Lux, will be investigated in the oral capsule formulation for the treatment of active and control of quiescent non-infectious uveitis in three separate pivotal protocols. Interested parties are encouraged to visit www.clinicaltrials.gov or contact Lux Biosciences for further information on the trial designs.
"We're very pleased that we've succeeded in moving this project along according to plan," commented Ulrich Grau, President & CEO of Lux Biosciences. "With preparations well under way, we look forward to enrolling our first patient into the pivotal studies by early January of next year. We believe that our next generation calcineurin inhibitor LX211 has great potential in uveitis; a well-studied and approved medication other than steroids would be enormously beneficial for patients who suffer from this debilitating disease."
Dr. Randall Yatscoff, Isotechnika's President & CEO stated, "Having ISA247 enter into pivotal trials for its third indication, uveitis, speaks to the versatility of the drug to potentially treat a number of immune-based health ailments. We are extremely pleased that our partner Lux Biosciences has been able to move this indication forward at such an aggressive pace." Dr. Yatscoff further stated, "We remain committed to advancing ISA247 in multiple indications to increase shareholder value and provide more effective treatments to kidney transplant patients and to those who suffer from psoriasis and uveitis."
Uveitis is an autoimmune disease resulting in chronic inflammation of the eye. Uveitis can be classified according to its location: anterior uveitis occurs in the front of the eye, intermediate uveitis occurs in the middle section of the eye, and posterior uveitis occurs at the back of the eye. Inflammation of all three locations is termed panuveitis. There is substantial evidence indicating the involvement of T-lymphocytes, key cells involved in inflammatory processes, in the development of uveitis.
Uveitis is an under-diagnosed and under-recognized medical condition that causes vision impairment, ocular pain, and loss of vision. Experts estimate that 10% of new cases of blindness in the U.S. are caused by this disease. Approximately 300,000 people suffer from uveitis in the U.S. alone, the majority of who are affected by anterior uveitis. The only therapeutic class approved by the FDA for treatment of uveitis is corticosteroids, which are burdened with multiple side effects, such as hypertension, hyperglycemia, and hypercholesterolemia.
Isotechnika Inc. is an international biopharmaceutical company headquartered in Edmonton, Alberta, Canada. Drawing upon its expertise in medicinal chemistry and immunology, the Company is focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments. Its entrepreneurial management and world- class team of scientists are building a pipeline of immunosuppressive drug candidates for treatment of autoimmune diseases and for use in the prevention of organ rejection in transplantation. Isotechnika looks to become the leader in development of immunosuppressant therapies.
Isotechnika's lead compound, ISA247 has successfully completed a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis. ISA247 is currently being investigated in a North American Phase IIb human clinical trial for the prevention of kidney graft rejection. The Company also has an additional immunosuppressive compound in its drug pipeline, TAFA93 which successfully completed Phase I clinical trials.
Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol ISA. More information on Isotechnika can be found at www.isotechnika.com.
About Lux Biosciences Inc.
Founded in 2005, Lux Biosciences is a privately held biotechnology company dedicated to the identification, optimization, development and commercialization of products for the treatment of ophthalmic diseases. The company has assembled a portfolio of product candidates based on compounds with demonstrated utility in non-ophthalmic indications that offer potential to address major market opportunities in the ophthalmic field. ISA247, or LX211 as it is known by Lux, is the most advanced of these and is expected to enter pivotal clinical trials for the treatment of uveitis by early 2007 and additionally offers a pipeline of other potential product applications. More information on Lux Biosciences can be found at www.luxbio.com.
This press release may contain forward-looking statements. Forward looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, the ability of the Company to defend its patents from infringement by third parties, and the risk that the Company's patents may be subsequently shown to be invalid or infringe the patents of others. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward- looking statements. Investors are cautioned against placing undue reliance on forward-looking statements.
ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar: http://www.presseportal.ch
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-780-487-1600 Ext. 246, Fax:
+1-780-484-4105, Email: email@example.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-780-909-4661, Fax: +1-780-484-4105,E-mail:
firstname.lastname@example.org; Lux Biosciences Contacts:
UlrichGrau, Ph.D., Lux Biosciences, Phone: +1-917-518-2875, E-mail:
email@example.com; Paul Kidwell, Suda Communications (media),
Phone: +1-617-296-3854, E-mail: firstname.lastname@example.org