Co-D Therapeutics Granted Orphan Designation for Triolimus for the Treatment of Angiosarcoma

MADISON, Wis, Apr. 28, 2015 /PRNewswire-iReach/ -- Co-D Therapeutics, Inc., a pre-clinical stage pharmaceutical company developing agents for the treatment of cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Co-D's request for orphan drug designation of Triolimus for the treatment of the highly lethal malignancy, angiosarcoma.

"We are pleased that Triolimus has been designated an orphan drug for the treatment of angiosarcoma," commented Dr. Kevin Kozak, co-founder and Chief Medical Officer of Co-D Therapeutics. "With few effective options, new agents for angiosarcoma treatment are urgently required. The orphan designation reflects both the FDA's and Co-D's commitment to addressing the unmet clinical needs of patients with rare diseases like angiosarcoma."

The Orphan Drug Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States. Orphan drug designation will entitle Co-D to seven years of market exclusivity for Triolimus as a treatment for angiosarcoma following marketing approval by the FDA. Additional benefits include tax credits related to clinical trial expenses, potential exemption from the FDA-user fee, assistance in clinical trial design, and smaller trials required for new drug applications.

"The designation of Triolimus as an orphan-drug for angiosarcoma treatment is an early and critical milestone and will facilitate progress through the clinical and regulatory development process," said Abdalla Saad, co-founder and Chief Executive Officer of Co-D Therapeutics. "We find our preclinical data compelling and are thrilled the FDA judged Triolimus meritorious of orphan-drug designation."

Triolimus technology was developed by Prof. Glen Kwon at the University of Wisconsin-Madison. "We are excited to continue the enormously rewarding process of advancing Triolimus to the clinic," said co-founder and Chief Scientific Officer Prof. Kwon.

Triolimus' intellectual property portfolio will be licensed from the Wisconsin Alumni Research Foundation (WARF). Funding from WARF's Accelerator Program supported pre-clinical development of Triolimus.

About Angiosarcoma

Angiosarcoma is a rare, aggressive malignancy of endothelial cell differentiation that has a propensity for both local recurrence as well as regional and distant metastases. Long-term disease-free survival is achieved in only half of patients who present with apparently localized disease. Average survival in patients who present with distant disease is less than one year. This poor survival is, in large part, attributable to a dearth of currently available, effective treatment options.

About Triolimus

Triolimus is a novel "3-in-1" nanoparticle that contains three proven anti-cancer agents in a non-toxic carrier. Triolimus is designed to be superior to currently available chemotherapies through both the elimination of toxic excipients often required for intravenous use and through the delivery of three, complementary drugs to maximize anti-cancer effects.

About Co-D Therapeutics, Inc.

Co-D Therapeutics is developing rationally designed, singularly packaged, combinations of anti-cancer agents to treat a broad spectrum of cancers. Using a novel nanoparticle platform technology to safely and conveniently deliver synergistic combinations of both cytotoxic and targeted anti-cancer agents, Co-D aims to maximize the therapeutic index. For additional information please visit www.co-drx.com

About WARF

The Wisconsin Alumni Research Foundation (WARF) is the private, nonprofit patent and licensing organization for the University of Wisconsin–Madison, one of the world's great research universities. WARF was founded in 1925 and is a pioneer and innovator among university-based technology transfer offices.

WARF's mission is to support, aid and encourage UW–Madison research by protecting its discoveries and licensing them to commercial partners for beneficial use in the real world. It is best known for commercializing groundbreaking vitamin D therapies, the revolutionary anticoagulant Coumadin®, innovative medical imaging and cancer radiation systems, and its patents for human embryonic stem cells. For additional information, please visit www.warf.org

INVESTOR CONTACT

Abdalla Saad, Chief Executive Officer

Co-D Therapeutics, Inc.

Phone: (608) 358-9655

Email: info@co-drx.com

Media Contact: Abdalla Saad, Co-D Therapeutics, Inc., 6083589655, info@co-drx.com

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SOURCE Co-D Therapeutics, Inc



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