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SymbioTec Signs Representation Contract With Tytonis


3/2/2009 12:23:09 PM

SymbioTec GmbH (“SymbioTec”, or the “Company”) and Tytonis B.V. (“Tytonis”) announce today that they have signed a representation contract under which Tytonis will support SymbioTec in its ongoing financing round and also to support the Company in the out-licensing of its lead clinical product ONCOHIST™, for the treatment of various cancers. The undisclosed contract contains a risk sharing provision under which Tytonis participates in the commercial risk involved with the product transaction process.

SymbioTec, founded in 1988 in Herborn by Dr. V. Rusch and Prof M. Zeppezauer, is a privately owned company. In 1999 the Company moved to the Starter Center of the Saarland University and in 2001 to the Science Park Saar 1 at the university campus of Saarbruecken. In 2001 SymbioTec achieved its first financing round with venture capital and funds from private investors which has funded the successful development of ONCOHIST™ from biotechnological process design through to toxicology and clinical phase Ib/IIb testing.

Tytonis, founded in 2006 by Dr. H. Luessen, is a privately owned company providing advisory services to a selected group of pharmaceutical companies to support them in Corporate/Business Development, Licensing, Valuation, Portfolio Strategy, Pharmaceutical Product Development and Drug Delivery related topics. Tytonis also operates within a highly reputated expert network of former industrial executives and distinguished experts, called “Pharma at Work”. Recently, Tytonis successfully closed a major license transaction with Bayer for its client Activaero on an undisclosed pulmonary delivery project.

ONCOHIST™ is an endogenous protein derived from the histone family. Prof. Zeppezauer’s group has found that it has remarkable antibacterial and oncolytic properties due to its particular structure and the presence of cationic properties. This is corroborated by its high presence in the small intestine where, in comparison to the colon region, almost no bacteria and only small incidence of cancer occur. The mechanism of action is related to its ability to bind to particular anionic charged phospholipids and other histone components. These only appear on the surface of irregular and fast growing tumor cells. Due to subsequent cell-lysis and apoptosis the cancer cells are killed without affecting other healthy cells and tissues in the body.

Applying ONCOHIST™ to all major known human-derived cancer cell lines demonstrated complete, effective eradication of the tumor cells in vitro. This was latterly confirmed in animal studies. Signs of efficacy were also noted in a recently concluded clinical phase Ib/IIa dose finding trial with 22 AML (Leukemia) patients. The ONCOHIST™ compound formulation showed no significant immunological and toxicological effects in either animals or humans. This may be explained by the fact that histones are genetically highly conserved endogenous proteins. The different mode of action of ONCOHIST™together with its high tolerability would make the compound highly interesting for combination therapies with other oncolytic drugs. ONCOHIST™ is protected by 10 patent families until 2028, of which 40 patents are already granted.

Prof. Dr. Michael Zeppezauer, CEO of Symbiotec, says: “SymbioTec is proud of having brought the first genuine oncolytic protein of human origin to the stage of clinical testing. Histone proteins are among the most versatile tools within the innate immune system with a huge potential to fight diseases caused by malignant or virus- transformed cells or by pathogenic microorganisms. Medicaments based on these Nature’s own weapons will be devoid of the inherent drawbacks of chemotherapeutics such as strong side effects due to interference with healthy dividing cells or selection of drug-resistant cancer cells.

The Orphan Medicinal Product Designation which was awarded to the Active Pharmaceutical Ingredients of ONCOHIST for treatment of Acute Myeloid Leukemia by the European Commission in December 2007 and by the FDA in October 2008 was based on the expectation of “significant benefit” for the patients in comparison with established therapies.

SymbioTec is also very satisfied with its newly closed alliance with TYTONIS which creates a strong partnership for promoting its drug and corporate business development.”

Dr. Henrik Luessen, CEO of Tytonis, says: “On becoming aware of the results of ONCOHIST™ during a symposium of the European Association of Pharma Biotechnology (EAPB) in October 2008 I could hardly believe that the product had not yet been partnered by one of the major players in the oncology field. However, learning that the product has still to be communicated to the pharmaceutical industry following the achievement of these highly promising clinical phase Ib/IIa data in AML patients we immediately offered to represent this highly exciting product opportunity, which may positively impact the quality of life of many cancer patients. We believe this product deserves to be brought to the market quickly. This is also the opinion of the Pharma at Work expert network which supports the ONCOHIST™ product with full commitment. We invite investors to participate in Symbiotec to develop the product to the next valuation point demonstrating efficacy in clinical phase II studies and subsequently qualified pharmaceutical companies in the oncology area to partner the ONCOHIST™ project with Symbiotec. We are open and flexible in our approach to negotiations and seek a timely and efficient process to bring the product to the medical community.”

For further information, please contact:

Henrik L. Luessen, Tytonis BV, telephone number +31 (6) 215 66 415 or e-mail henrik.luessen@tytonis.com. A non-confidential factsheet providing further detailed information can be downloaded from the Tytonis website: www.tytonis.com/licensing.htm.

This document may contain certain forward-looking statements relating to the business, financial performance and results of Tytonis B.V., Symbiotec GmbH and the industry in which it operates. These statements are based on Tytonis’ and Symbiotec’s current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words “expect”, “anticipate”, “predict”, “estimate”, “project”, “plan”, “may”, “should”, “would”, “will”, “intend”, “believe” and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements.


Read at BioSpace.com

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