EDMONTON, Aug. 7 /CNW/ - Isotechnika announced today that the Food and
Drug Administration (FDA) of the United States granted fast track designation
for the Company's lead drug, ISA247 under section 506 of the Federal Food,
Drug and Cosmetic Act. The FDA based its decision on the following reasons:
- ISA247 is intended for the treatment of a serious or life-threatening
condition, namely non-infectious posterior, intermediate and
- ISA247 demonstrates the potential to address medical needs unmet by
available treatments for non-infectious posterior, intermediate and
Fast Track designation will provide various means to expedite the
development and review of ISA247. The process could be facilitated through
meetings and other correspondence with the FDA reviewers, consideration for
priority review, and the ability to submit portions of the New Drug
Application (NDA) early for review as part of a "rolling" submission.
"Thanks to the FDA's approval for Fast-Track designation, we have the
potential to more rapidly deliver to patients a much needed drug for uveitis,"
comments Ulrich Grau, PhD, president and chief executive officer of Lux
Biosciences. "If successful, LX211 (referred to as ISA247 by Isotechnika)
would be the first thoroughly tested and approved steroid-sparing therapy for
the treatment of uveitis."
"We are extremely excited that Lux received Fast-Track designation for
ISA247 for the treatment of uveitis," stated Dr. Randall Yatscoff,
Isotechnika's president & chief executive officer. "We are continually
encouraged by the broad potential use of ISA247 in transplantation, psoriasis,
Lux Biosciences began enrolling patients in pivotal clinical trials for
ISA247 earlier this year. The company is conducting three controlled,
double-masked studies aimed at supporting the approval of that product as a
treatment for uveitis, collectively designated the LUMINATE program.
Enrollment for the LUMINATE trial program is expected to be completed by early
2008 and, if successful, Lux plans to seek regulatory approval for LX211 in
late 2008. The LUMINATE program represents the largest and most comprehensive
clinical program ever undertaken in the field of uveitis.
Edmonton-based Isotechnika Inc. is an international biopharmaceutical
company focused on the discovery and development of novel immunosuppressive
therapeutics that are designed to offer advantages over other currently
available treatments while offering therapeutic choices to clinicians.
Isotechnika looks to become the market leader of drug therapies for
indications such as transplantation of solid organs (with Hoffman La Roche)
and treatment of autoimmune disorders such as uveitis (with Lux Biosciences)
There is a significant unmet medical need in the treatment of both solid
organ transplantation and autoimmune disease. It is estimated that the market
potential exceeds $2 billion annually in sales for calcineurin inhibitors such
as ISA247. Isotechnika's lead drug, ISA247, has successfully completed a Phase
3 Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is
currently being investigated in a Phase 3 European/Canadian psoriasis trial
and a Phase 2b North American trial for the prevention of kidney graft
rejection subsequent to transplantation.
Isotechnika Inc. is a publicly traded company on the Toronto Stock
Exchange under the symbol "ISA". More information on Isotechnika can be found
Partnerships with Isotechnika Inc.
Isotechnika Inc. signed a collaboration agreement with Hoffman La Roche
on April 9, 2002, which licensed the worldwide rights to develop and
commercialize ISA247 for all transplant indications.
On September 30, 2005, Isotechnika Inc. entered into an exclusive
worldwide licensing agreement with Atrium Medical Corporation for the use of
ISA247 and TAFA93 specifically with drug eluting devices for the non-systemic
treatment of vascular, cardiovascular, target vessel and tissue disorders.
Isotechnika Inc. and Cellgate Inc. signed an option agreement on April
25, 2006, granting Isotechnika the option to obtain an exclusive license to
develop and commercialize conjugates consisting of Cellgate's patented
transporter technology for the topical delivery of ISA247 in patients
suffering from mild to moderate psoriasis.
On May 25, 2006, Isotechnika Inc. signed an agreement with Lux
Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences
worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247
for the treatment and prophylaxis of all ophthalmic diseases.
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
For further information:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: (780) 487-1600 (247), Fax: (780) 484-4105,
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 909-4661, Fax: (780) 484-4105,