Navigation Links
Genaera Begins Phase 1b Trial of Trodusquemine (MSI-1436) in Overweight and Obese Type 2 Diabetics
Date:12/1/2008

PLYMOUTH MEETING, Pa., Dec. 1 /PRNewswire-FirstCall/ --Genaera Corporation (Nasdaq: GENR) today announced that dosing of subjects has begun in study MSI-1436C-102 (Study 102), the multiple ascending dose Phase 1b study of trodusquemine (MSI-1436) in overweight and obese type 2 diabetics. MSI-1436 is a novel therapeutic for the treatment of type 2 diabetes and obesity which works centrally and peripherally to regulate insulin and leptin pathways through the highly selective inhibition of its novel target enzyme, PTP-1B.

Study 102 will establish multiple dose pharmacokinetics (PK) and expand the safety database for MSI-1436 in a population of overweight and obese adult type 2 diabetic subjects who are poorly controlled on metformin. The study will also evaluate key secondary outcomes in this population, including oral glucose tolerance and insulin sensitivity, satiety and weight loss.

"We hope that Study 102 will help establish proof-of-concept for MSI-1436 as a highly competitive treatment for both type 2 diabetes and obesity with a single drug," said Jack Armstrong, President and Chief Executive Officer of Genaera. "In two previous Phase 1 studies, single doses of MSI-1436 administered to over 60 subjects were well-tolerated with an acceptable adverse event profile, exhibited linear PK, produced dose-dependent weight loss and improved insulin sensitivity. We expect the multiple dose data from Study 102 to verify the exciting potential and positive efficacy results of this drug."

Study 102 is a double-blind, randomized, placebo-controlled, safety and PK study being conducted at two U.S. sites. The study will initially enroll 21 subjects at three dose levels (3, 6, and 10 mg/m2) of MSI-1436 with treatment occurring every three days over a 23 day period. Five subjects in each dosing group will receive MSI-1436 and two subjects in each dosing group will receive placebo. The multiple ascending dose protocol has an adaptive design permitting the enrollment of additional subjects in each cohort. Data from the study is expected in the first half of 2009.

MSI-1436 is also being evaluated in preclinical studies using a once-weekly subcutaneously administered formulation which Genaera expects to utilize in Phase 2 clinical trials in the second half of 2009.

About Trodusquemine (MSI-1436)

Trodusquemine is a centrally and peripherally-acting appetite suppressant and the first highly selective inhibitor of protein tyrosine phosphatase 1B (PTP1B), an enzyme central to controlling the function of both the leptin and insulin pathways. By inhibiting PTP1B, MSI-1436 is expected to decrease appetite and normalize blood sugar. Trodusquemine has produced consistent, sustainable weight loss in a variety of animal models and appears to overcome metabolic readjustment, which often limits sustained weight loss during caloric restriction. In addition, trodusquemine has shown the ability to reverse co-morbidities associated with obesity such as abnormal glucose metabolism and cholesterol elevation.

About Genaera

Genaera Corporation is developing trodusquemine (MSI-1436), for type 2 diabetes and obesity currently in Phase 1 clinical testing and has a fully out-licensed partnership with MedImmune, Inc. that is in Phase 2 clinical testing in asthma. For further information, please see our website at www.genaera.com.

This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management's current views and are based on certain expectations and assumptions. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "believe," "continue," "develop," "expect," "plan" and "potential" or other words of similar meaning. Genaera's actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of risk factors, including, but not limited to the risks and uncertainties discussed in Genaera's filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at www.sec.gov as well as other sources. You are encouraged to read these reports. Given the uncertainties affecting development stage pharmaceutical companies, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements or the risk factors that may relate thereto.


'/>"/>
SOURCE Genaera Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Genaera Corporation Presents Interim Phase 1 Data for Obesity Compound Trodusquemine (MSI-1436) at IBC Conference
2. MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera
3. Genaera Corporation Presents Preclinical Trodusquemine (MSI-1436) Data at the North American Association for the Study of Obesity Annual Meeting
4. Genaera Corporation Presents Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting
5. Genaera Corporation Provides Highlights of Positive Phase 1 Trodusquemine (MSI-1436) Data from the North American Association for the Study of Obesity Annual Meeting
6. Genaera Begins Dosing Second Phase 1 Trial of Type 2 Diabetes and Obesity Compound Trodusquemine (MSI-1436)
7. Genaera Announces Diabetes IND In Effect for Trodusquemine (MSI-1436)
8. Genaera Corporation Presents Promising Preclinical Type 2 Diabetes Data for Trodusquemine (MSI-1436) at Keystone Symposia
9. Genaera Announces MedImmune Initiation of Phase 2a Trial of Antibody Targeting Interleukin-9 in Patients with Asthma
10. Genaera Corporation Announces MSI-1436 Data Presented at Society of Neuroscience Meeting
11. Genaera Corporation Presents Additional Promising Preclinical Type 2 Diabetes Data for Trodusquemine (MSI-1436) at American Diabetes Association
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/7/2017)...  Diplomat Specialty Infusion Group, a brand of Diplomat Pharmacy, Inc. ... Iowa location. The Iowa ... an ISO 7 cleanroom—the standard needed to compound intravenous (IV) nutrition ... of pollutants. "Our new cleanroom ... serve our Iowa patients," said Phil ...
(Date:6/1/2017)... 2017 Nutriceutical Holdings (NH), parent company of ... and KD Pharma Group have decided to join forces ... Pharma Group. KD Pharma Group will become the largest ... the entire company. "We believe we have ... to growing the NH companies by providing us with ...
(Date:5/26/2017)... 2017  Endo International plc (NASDAQ: ENDP ) ... will represent the Company in a fireside chat at Goldman ... June 13, 2017 at 10:40 a.m. PT / 1:40 p.m. ... Rancho Palos Verdes, CA. ... be available on the Company,s website at http://www.endo.com/investors/overview . ...
Breaking Medicine Technology:
(Date:6/24/2017)... ... June 24, 2017 , ... Dr. ... 217 Portion Road in Lake Ronkonkoma, Dental365 offers patients high-quality and affordable routine ... visits to the dentist fit into their patients’ busy lifestyles. Dental365 also gladly ...
(Date:6/23/2017)... ... 2017 , ... "The Better Care Reconciliation Act (BCRA) falls ... people with all chronic conditions, including mental illnesses, while increasing the cost of ... Care Act (ACA) requirement that insurers cover pre-existing conditions, it does not require ...
(Date:6/23/2017)... ... 2017 , ... The Military Officers Association of America (MOAA) announced its support ... retired Marine Col. Thomas G. Bowman. , Bowman currently serves as the staff director ... with the issues and challenges veterans face with the VA. Following a 30-year career ...
(Date:6/23/2017)... ... June 23, 2017 , ... Goodcents Deli Fresh Subs today announced the opening ... 4210 SW 21st St. Topeka, Kan. 66604 (near 21st and Gage). It is owned ... owns three other locations in the Topeka and Bonner Springs, Kan. area. , ...
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and South ... selected 21 leaders from government, business and civil society in 11 countries across the ... this fall, engaging in a transformative exchange of knowledge and ideas with the leading ...
Breaking Medicine News(10 mins):