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Proteo, Inc./Proteo Biotech AG – Minapharm/Rhein Minapharm Biogenetics SAE: Approval for a Phase II clinical trial with Elafin in kidney transplantation

Irvine, CA – Kiel – Cairo, December 10, 2008 – Proteo, Inc. (OTCBB: PTEO; Frankfurt Freiverkehr: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG together with Minapharm Pharmaceuticals SAE (Cairo and Alexandria Stock Exchange: MIPH) and its subsidiary Rhein Minapharm Biogenetics SAE announced today that the responsible authority in Cairo has granted approval for a Phase II clinical trial to study the efficacy of Elafin on kidney transplant patients.

The study will be conducted as a randomized, double-blinded, placebo-controlled Phase II trial for prevention of acute and chronic allograft nephropathy at the University of Cairo. The aim of the trial is to investigate the effectiveness of Elafin at suppressing the inflammatory processes that frequently occur after transplantation and contribute to organ rejection and accelerated aging of the transplanted organ.

A further Phase II clinical trial on patients undergoing esophagectomy for esophagus carcinoma has already been started in the Clinic for General and Thorax Surgery at the University Hospital of Schleswig-Holstein, Campus Kiel.

In 2007 Proteo and Minapharm have entered into a license agreement for the clinical development, production and marketing of Elafin in Egypt, Middle Eastern and African countries. Proteo will receive an upfront payment, milestone-payments and royalties on net product sales. In addition, Minapharm will take over the funding of clinical research activities for the designated region.

About Elafin

The developmental drug Elafin is produced naturally in humans and inhibits enzymes responsible for the formation of circulating factors (cytokines) that can cause inflammatory reactions. In kidney transplantation these inflammatory processes are considered to be responsible for the occurrence of acute rejections and chronic damages of the transplanted organ.

The anti-inflammatory properties of Elafin during and the first few days after transplantation should ensure a rapid resumption of normal kidney function without chronic injuries caused by the endogenous inflammatory mechanisms.

About Proteo

The company researches, develops and markets compounds for biological and medical research as well as for use as pharmaceuticals. PROTEO holds the production and utilization rights for recombinant human Elafin. PROTEO intends to out-license selected indications and to establish international strategic alliances in order to open up new fields of application and for marketing (www.proteo.de).

About Minapharm

Minapharm, headquartered in Cairo with its production facilities in the tenth of Ramadan, is among the leading prescription medicine companies in Egypt and the Middle East. The company is specialized in the manufacture and marketing of innovative pharmaceuticals and through its subsidiary Rhein-Minapharm-Biogenetics, in the research, development and manufacturing of biopharmaceuticals. Its biotech subsidiary is focussing on the core therapeutic areas of liver disease and thrombosis & haemostasis. With three therapeutic proteins already marketed and several in the pipeline, Minapharms competence lies in decreasing time to market without compromising ethical and safety standards. By combining its expertise in pharmaceuticals and leadership in biopharmaceuticals Minapharm, along with its worldwide strategic alliances, contributes significantly to the quality of life of many people in the region. Minapharm employs a collective workforce of over 700 and is listed on the Cairo and Alexandria stock exchange (www.minapharm.com).

Forward-Looking Statements

Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Technical complications that may arise could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these forward looking statements and risks and uncertainties involved are further qualified by other factors including, but not limited to those set forth in the company's Form 10-KSB filing and other filings with the United States Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events or otherwise.

Contact

Barbara Kahlke, PhD
Proteo Biotech AG
Am Kiel-Kanal 44
D-24106 Kiel
E-Mail: info@proteo.de
Phone: +49(0)431 8888462
Fax: +49(0)431 8888463

Frank Müller
R&D Manager
Minapharm Pharmaceuticals
E-Mail: mueller@minapharm.com

https://proteo.de/pages/12/press-releases/2008/12/10/approval-for-a-phase-ii-clinical-trial-with-elafin-in-kidney-transplantation/ – printed on 2018-11-16 6:06:22