Market_Stalker
5 years ago
COMPANY PRESS RELEASE
Proteo, Inc. / Proteo Biotech AG:
Proteo’s Elafin Enters The Clinic For Subcutaneous Use In
Pulmonary Arterial Hypertension
Irvine, CA, Kiel, March 28, 2019 - Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG today announced the start of the clinical development for the subcutaneous use of Proteo’s lead investigational drug candidate Elafin (INN: Tiprelestat).
The Duke University Early Phase Research Unit initiated the recruitment of healthy individuals for the Phase I clinical trial in the U.S. to assess the safety and tolerability of repeated single doses of Elafin. Proteo’s research partners and investigators at Stanford University School of Medicine, Dr. Marlene Rabinovitch and Dr. Roham Zamanian, are
responsible for the conduct of the investigator-initiated trial. The trial with the title “Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects” marks the beginning of the clinical development program of
Elafin for chronic use initially focusing on the treatment of patients suffering from the still fatal disease pulmonary arterial hypertension (PAH). Elafin has received orphan drug designations in the USA and the EU for the treatment of PAH.
About Proteo's Elafin clinical development program
Proteo's biopharmaceutical drug candidate Elafin promises an excellent therapeutic benefit risk profile for the use as an anti-inflammatory and tissue protective drug. Elafin is identical to the human protein elafin with high specificity for tissue destroying and inflammation promoting proteases. The development program of Elafin is focused on the late stage development of Elafin in major surgery and early stage development in pulmonary arterial hypertension (PAH). Elafin has received orphan drug designations in the USA and the EU for esophageal cancer surgery (ECS) and PAH. So far, there were no safety concerns after the treatment of 75 patients in three randomized, double-blind, placebo-controlled clinical trials. Postoperative complications in major surgery are the most significant independent risk factor leading to high morbidity and hospital readmissions. Following the completion of two Phase II surgery trials in ECS and coronary artery bypass graft surgery, and a final European Medicines Agency advice letter, a European pivotal trial with Elafin in ECS is in preparation. Treatment of patients undergoing ECS resulted in a significantly shorter intensive care unit stay and a positive postoperative effect on liver and kidney markers. Treatment of patients undergoing coronary artery bypass surgery resulted in a postoperative reduction of the heart damage marker troponin I. In models of PAH it was shown that Elafin reverses obliterative changes in arteries of lung explants from PAH patients and that treatment with Elafin leads to the regression of pulmonary vascular lesions in rats. PAH is still a fatal disease with high medical need for therapies that stop disease progression.
About Proteo
Proteo focuses on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Elafin for life threatening surgeries and life-threatening diseases such as PAH. Proteo seeks partners and investors for the development, commercial scale manufacturing, marketing and distribution of the product. Proteo, Inc.
common stock is quoted on the OTCQB under the symbol PTEO (www.proteo.us). The company has one wholly owned subsidiary, Proteo Biotech AG, Kiel, Germany (www.proteo.de).
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-K 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
Dr. Jürgen Paal
Proteo Biotech AG
Am Kiel-Kanal 44
D-24106 Kiel
Email: info@proteo.de
Telephone: +49 431 8888-462
Fax: +49 431 8888-463
Market_Stalker
5 years ago
Tiny Float - 11,026,991
PTEO SECURITY DETAILS
Share Structure
Market Cap
1,119,571
02/25/2019
Authorized Shares
300,000,000
02/20/2019
Outstanding Shares
24,879,350
02/20/2019
Restricted
17,774,236
02/20/2019
Unrestricted
7,105,114
02/20/2019
Held at DTC
6,167,195
02/20/2019
Float
11,026,991
05/09/2018
Par Value
0.00
Market Value calculated only for respective security
Transfer Agent
Transfer Online, Inc.
Shareholders
Shareholders of Record 1,740
Market_Stalker
5 years ago
Status of Clinical Development
https://proteo.us/proteo-inc/r-und-d/clinical-development.html
CLINICAL DEVELOPMENT
Acute Therapy
Phase I Safety and tolerability
completed
Phase II Esophageal cancer surgery completed
Phase II Coronary artery bypass surgery completed
Phase III Esophageal cancer surgery preparing
Chronic Therapy
Phase I Safety and tolerability planned
Phase II Pulmonary arterial hypertension planned
Safety and Tolerability in Acute Therapy
In a double-blind, randomized and placebo-controlled Phase I single dose escalating trial Elafin was well tolerated by healthy human subjects. In two Phase II studies with patients undergoing surgery for esophageal cancer and with patients undergoing coronary artery bypass grafting the excellent tolerability was confirmed.
Esophageal Cancer Surgery
Esophageal cancer mainly occurs in elder patients over 50. Complete surgical removal of the tumor offers the best chance of a cure. This surgical procedure, which can last up to 6 hours, is one of the most invasive surgical interventions and is associated with frequent and severe postoperative inflammatory complications leading to delayed recovery, prolonged need of intensive care and substantial postoperative mortality.
In a double-blind, randomized and placebo-controlled Phase II clinical trial intravenously administered Elafin had a positive effect on the period of recovery: 63 percent of the Elafin treated patients required only one day of intensive care in contrast to patients receiving placebo which all needed several days.
Currently, Proteo is preparing a double-blind, randomized and placebo-controlled Phase III clinical trial in this acute therapy indication. Proteo has already obtained protocol assistance by the European Medicines Agency (EMA) and the trial is scheduled to start in 2016. The trial is designed to demonstrate efficacy which is required for an application to receive marketing approval for the European market.
The European Commission has granted Orphan Drug Designation for Elafin to be used in the treatment of esophageal cancer and the FDA has granted Orphan Drug Designation for Elafin for the prevention of inflammatory complications of transthoracic esophagectomy within the United states. The EMA and the FDA agreed that no investigations in pediatric populations will be performed, as children are almost not affected by this kind of cancer.
Coronary Artery Bypass Surgery
Coronary artery bypass surgery is a procedure performed to relieve angina pectoris and reduce the risk of death from coronary artery disease. It is the most frequently performed operation in cardiovascular surgery. This surgical procedure is associated with postoperative myocardial and systemic inflammation which contributes to the substantial risk of postoperative myocardial infarction, pulmonary and renal failure as well as stroke. Cardiovascular surgeons agree that there is an urgent need for pharmaceuticals that can be administered to prevent these postoperative complications, to improve the overall benefit of bypass surgery for the patients.
A double-blind, randomized and placebo-controlled Phase II clinical trial (EMPIRE) has been conducted at the University of Edinburgh under the lead of Dr. Peter Henriksen with 85 patients undergoing coronary artery bypass graft surgery (Alam et al., Heart 2015). The patients have been treated with a single perioperative infusion of either Elafin or placebo. This trial contributed much to our understanding of the therapeutic potential of Elafin and the time course of myocardial injury in CABG. Troponin I plasma concentrations, a marker of myocardial damage, was reduced by 41% as long as pharmacologically relevant concentrations of Elafin were present in the blood. This trial provided sufficient information for the design of a follow up study. The trial was supported by the Medical Research Council (MRC) and Chest Heart & Stroke Scotland (CHSS) with more than GBP 500,000.
Safety and Tolerability in chronic therapy
A Phase I trial in the US with subcutaneously administered Elafin funded by the NIH is planned to commence with recruitment in December 2018. The designs of the Phase I clinical trial and a Phase II proof of concept trial in Pulmonary Arterial Hypertension (PAH) have been discussed with the FDA.
Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) is a severe and, as yet, incurable lung disease which, if left untreated, is fatal within a few years.PAH is caused by the progressive narrowing of the pulmonary arterial blood vessels. This is due to a pathological proliferation of the muscle cells within the vessel wall and the subsequent transformation of the muscle cells into connective tissue. The resulting narrowing of the pulmonary artery blood vessels leads to a decrease in oxygen supply to the body and, due to increased pulmonary blood pressure, to a substantial overexertion of the heart. Affected patients suffer from severely reduced exercise capacity. While currently available treatments have increased life expectancy by 5 to 7 years by retarding the advancement of the disease, they cannot completely stop disease progression. Elafin represents a novel therapeutic approach to suppress and reverse the underlying arterial wall pathology, and address an unmet therapeutic need for PAH.
Proteo has received orphan drug designations for Elafin in the USA for the treatment of pulmonary arterial hypertension (PAH) and in the European Union for the treatment of PAH and chronic thromboembolic pulmonary hypertension.
Since 2008, Proteo has been cooperating with a team of scientists at Stanford University in California lead by Dr. Marlene Rabinovitch for the preclinical development of Elafin in the field PAH. Marlene Rabinovitch has published over 150 scientific papers and is among the leading scientists worldwide in the area of pulmonary hypertension. For more than a decade, she has been studying the significance of Elafin in vascular disease. Since 2011, the NIH National Heart, Lung and Blood Institute (NHLBI) has been supporting the Elafin PAH development program at Stanford University with a five-year high volume grant.
In November 2015, Proteo and investigators from Stanford University School of Medicine were invited by the FDA for a pre-IND meeting to discuss the development plan for Elafin in the treatment of PAH after major advances in preclinical research had been made by a Stanford team of researchers led by Professor Marlene Rabinovitch (Nickel et al., Am J Respir Crit Care Med. 2015).
MADDSTACKER
5 years ago
Proteo, Inc. / Proteo Biotech AG:
Proteo Receives GLP Certificate From Competent Authority
Irvine, CA, Kiel, February 25, 2019 - Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG today announced that the competent Good Laboratory Practice (GLP) Monitoring Authority of the German State of Schleswig-Holstein (State Office for Agriculture, Environment and Rural Areas of the Land Schleswig-Holstein) has performed a GLP inspection resulting in the confirmation that the Proteo R&D test site is able to conduct the archiving of documents related to in-house development products in compliance with the Principles of GLP. The establishment of a GLP quality management system is supported by a BFEI grant from the German State of Schleswig-Holstein.
About Proteo's Elafin clinical development program
Proteo's biopharmaceutical drug candidate Elafin promises an excellent therapeutic benefit risk profile for the use as an anti-inflammatory and tissue protective drug. Elafin is identical to the human protein elafin with high specificity for tissue destroying and inflammation promoting proteases. The development program of Elafin is focused on the late stage development of Elafin in major surgery and early stage development in pulmonary arterial hypertension (PAH). Elafin has received orphan drug designations in the USA and the EU for esophageal cancer surgery (ECS) and PAH. So far, there were no safety concerns after the treatment of 75 patients in three randomized, double-blind, placebo-controlled clinical trials. Postoperative complications in major surgery are the most significant independent risk factor leading to high morbidity and hospital readmissions. Following the completion of two Phase II surgery trials in ECS and coronary artery bypass graft surgery, and a final European Medicines Agency advice letter, a European pivotal trial with Elafin in ECS is in preparation. Treatment of patients undergoing ECS resulted in a significantly shorter intensive care unit stay and a positive postoperative effect on liver and kidney markers. Treatment of patients undergoing coronary artery bypass surgery resulted in a postoperative reduction of the heart damage marker troponin I. In models of PAH it was shown that Elafin reverses obliterative changes in arteries of lung explants from PAH patients and that treatment with Elafin leads to the regression of pulmonary vascular lesions in rats. PAH is still a fatal disease with high medical need for therapies that stop disease progression. A Phase I trial in the US with subcutaneously administered Elafin is planned to commence with recruitment in 2019.
About Proteo
Proteo focuses on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Elafin for life threatening surgeries and life-threatening diseases such as PAH. Proteo seeks partners and investors for the development, commercial scale manufacturing, marketing and distribution of the product. Proteo, Inc. common stock is quoted on the OTCQB under the symbol PTEO (www.proteo.us). The company has one wholly owned subsidiary, Proteo Biotech AG, Kiel, Germany (www.proteo.de).
db7
7 years ago
10q excerpts:
"
In April 2017, we received the final report of the respiratory safety pharmacology study in rats. The study was conducted by a third party laboratory in the US. It was conducted in accordance with the FDA “Good Laboratory Practice for Nonclinical Laboratory Studies” (GLP). The objective of this study was to evaluate the acute respiratory effects of Elafin when administered subcutaneously to rats. Single subcutaneous administrations of Elafin to rats resulted in no test article-related changes in the measured respiratory parameters (respiratory frequency, tidal volume, or minute volume) and were well tolerated.
"
"
In April 2017, Dr. Wiedow agreed in writing to waive any non-payment defaults under the License Agreement and to defer all current payments to June 2020
"
"
On September 9, 2016, the Company entered into a Preferred Stock Purchase Agreement (the “Agreement”) with a third-party (“Investor”). Pursuant to the Agreement, the Company agreed to issue and sell to the Investor 1,000,000 shares of the Company’s Series B-1 Preferred Stock at the price of 1.00 Euro per share, for an aggregate purchase price of 1,000,000 Euro and the Investor agreed to purchase such shares no later than March 31, 2017. Further details are described in the Company's Current Report on Form 8-K filed with the SEC on September 13, 2016.
During 2016, the Company received 15,000 Euro ($16,000) from the Investor, as a refundable deposit for the Initial Closing Date. Such amount is included in accounts payable and accrued liabilities in the accompanying consolidated balance sheet at December 31, 2016. In March 2017, the Company received an additional 5,000 Euro from the Investor; however, the full purchase was not received by March 31, 2017.
No shares of preferred stock were issued during the three month periods ended March 31, 2017 and 2016.
Subsequent to March 31, 2017, the Company received an additional 5,000 Euro from the Investor. The Company is currently negotiating with the Investor to complete the transaction.
"
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