Clavis Pharma licenses LVT compound CP-4033 to translational therapeutics for development in aggressive thyroid tumours

Clavis Pharma licenses LVT compound CP-4033 to translational therapeutics for development in aggressive thyroid tumours

Oslo, Norway, 16 May 2011

Clavis Pharma ASA (OSE: CLAVIS), a Norwegian cancer drug development company, and Translational Therapeutics, Inc., a Massachusetts, USA based private biopharmaceutical company, announced today that they have entered into a strategic licensing agreement regarding the development and commercialization of CP-4033.

CP-4033 is a patented, Lipid Vector Technology (LVT) derivative of ribavirin currently in the preclinical stage of development. Translational Therapeutics will develop CP-4033 for use in the treatment of aggressive thyroid cancer and will evaluate the potential of CP-4033 for use in the treatment of other solid tumours.

Clavis Pharma's intellectual property (IP) surrounding CP-4033 is complementary to Translational Therapeutics' IP estate around the use of ribavirin analogues for the treatment of human cancers and its companion diagnostic and therapeutic response monitoring technologies. The combined patent estate provides a solid foundation upon which to base a targeted cancer drug development programme.

Under the terms of the agreement, Translational Therapeutics will be responsible for all future development of CP-4033. Clavis Pharma will receive a minority equity stake in Translational Therapeutics and potential future milestone and royalty payments.  Further terms of the agreement were not disclosed.

Aggressive thyroid cancer belongs to the family of so-called elF4E cancers, which demonstrate abnormally high activity of the translation factor and oncogene, elF4E. Elevated levels of elF4E are known to promote cell growth, metastasis, and angiogenesis, and inhibit programmed cell death. Ribavirin has been demonstrated to antagonize eIF4E's oncogenic effects and preclinical studies with CP-4033 conducted by Translational Therapeutics demonstrate that CP-4033 appears to be even more effective at inhibiting eIF4E's oncogenic activities. Elevated elF4E activity is believed to play a role in about 30% of human cancers. 

Olav Hellebø, CEO of Clavis Pharma, said: "This deal for CP-4033 is part of our strategy to leverage our Lipid Vector Technology platform to create new and improved drug candidates based on already well-established drugs.  As we are focused on the development of our three most advanced compounds; elacytarabine and CP-4126 in Phase III and pivotal Phase II clinical trials respectively, and CP-4200, which will soon enter Phase I clinical trials, we are delighted that Translational Therapeutics will take on the development of this preclinical asset."

Gordon Jamieson, CEO of Translational Therapeutics, said: "This agreement advances our strategy of commercializing high-value cancer therapeutic systems that provide superior, personalized, evidence-based clinical care solutions for the treatment of high-grade, poor prognosis human cancers.

About Clavis Pharma
Clavis Pharma ASA is a late clinical stage oncology discovery and drug development company based in Oslo, Norway with a portfolio of novel anti-cancer drugs in development. These patented New Chemical Entities (NCEs) are novel, improved versions of commercially successful drugs, made using Clavis Pharma's Lipid Vector Technology (LVT) chemistry. Data generated suggests these potential breakthrough products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue penetration, altered metabolism and, in certain cases, additional modes of action.

Clavis Pharma's has several drug candidates in formal development studies:

◦Elacytarabine, a leukaemia drug, currently in a randomized, controlled Phase III study in late-stage acute myeloid leukaemia;

◦CP-4126, is currently in a pivotal clinical study compared to gemcitabine for the 1st line treatment of pancreatic cancer and a Phase II trial for 2nd line treatment for pancreatic cancer in patients refractory to 1st line gemcitabine treatment;

◦CP-4200, an azacitidine derivative, in preclinical development for myelodysplastic syndrome (MDS), a disease that is often a precursor to leukaemia. 


Clavis Pharma intends to commercialise its products through strategic alliances and partnerships with experienced oncology businesses and, where and when commercially appropriate, by establishing its own sales and marketing capabilities. CP-4126 is licensed to Clovis Oncology globally. Clavis Pharma has an option to co-promote CP-4126 in Europe.

About Translational Therapeutics
Translational Therapeutics, Inc. (Arlington, Massachusetts, USA) is a biopharmaceutical firm focused on commercializing cancer therapeutic systems that provide superior, personalized, evidence-based clinical care solutions for the treatment of high-grade, poor prognosis human cancers.

The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.

This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

No expressed or implied representations or warranties are given concerning Clavis Pharma or the accuracy or completeness of the information or projections provided herein, and no claims shall be made by the recipient hereof by virtue of the information or projections contained herein. Clavis Pharma is a registered trademark of Clavis Pharma ASA.

This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.