IRVINE, Calif. & KIEL, Germany--(BUSINESS WIRE)--Proteo, Inc. (OTCBB: PTEO; Frankfurter Freiverkehr: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today:
The Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) has issued a recommendation granting orphan drug status to Proteo's drug candidate Elafin for the treatment of esophagus carcinoma. The orphan drug status will become effective upon ratification of this recommendation by the European Commission. This is expected to occur in the last quarter of 2009. Elafin was also granted orphan drug status for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension in 2007. This latest decision further highlights the considerable therapeutic potential of this drug.
Orphan drug status assures exclusive marketing rights for the treatment of the respective disease within the EU for a period of up to ten years after receiving market approval. In addition, a simplified, accelerated and less expensive approval procedure with the assistance of EMEA can be drawn upon. Patients undergoing esophagectomy for esophagus carcinoma are currently being treated with Elafin within the framework of a Phase II clinical trial. A follow-up study after completion of this trial in 2010 is already being planned.
Proteo's drug substance Elafin is an endogenous protein produced by the human body and is a natural inhibitor of the two tissue destroying enzymes, neutrophil elastase and proteinase-3. Both of these enzymes are known to be involved in the inflammatory response occurring in a variety of diseases. Elafin's ability to block the activity of destructive enzymes that are involved in inflammatory reactions makes it a highly promising active compound for the treatment of inflammatory lung diseases or severe reperfusion injuries.
The excellent tolerability of recombinant Elafin for injection in human subjects was demonstrated in a Phase I clinical trial. A Phase II clinical trial on patients undergoing esophagectomy for esophagus carcinoma has been started in the University Hospital of Schleswig-Holstein, Campus Kiel in November 2008. The aim of the trial is to investigate the effectiveness of Elafin at suppressing the postoperative inflammatory processes. A further Phase II clinical trial has already been approved: Minapharm Pharmaceuticals SAE, Cairo, will initiate a Phase II clinical trial to study the efficacy of Elafin on kidney transplant patients. The study will be conducted as a Phase II trial for prevention of acute and chronic allograft nephropathy at the University of Cairo. Within the framework of a collaboration, it is intended to investigate the effect of Elafin on the damage and inflammation of cardiac muscle after coronary bypass operations in a Phase II clinical trial at the University of Edinburgh.
The company researches, develops and markets compounds for biological and medical research as well as for use as pharmaceuticals. The main focus is on anti-inflammatory drugs, in particular on the human elastase inhibitor 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).
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.
Further information: www.proteo.de