Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Emisphere -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (229)	10/28/2005 10:31:36 PM
From: Harold Engstrom	Respond to of 272

Thank you very much for your opinion Miljenko, Harold

To: Miljenko Zuanic who wrote (229)	10/28/2005 10:57:07 PM
From: hmpa	Read Replies (1) \| Respond to of 272

Heparin is too complex to prove (easily) that iv/sc dosing and oral formulation generate the same active molecule in blood stream. Presumably, yes/no answer to this (to FDA's satisfaction) will be available within a few months: Press Release Source: Emisphere Technologies, Inc. Emisphere Technologies Completes Dosing in Heparin Clinical Trial Monday September 19, 8:00 am ET TARRYTOWN, N.Y., Sept. 19 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) today announced that it has completed dosing all arms of a clinical trial to compare heparin delivered by intravenous and subcutaneous injection to Emisphere's oral heparin capsule formulation, which uses the eligen® technology. The purpose of the study is to demonstrate that heparin delivered by the oral route by means of the eligen® technology remains unaltered and has the same molecular composition as heparin administered by the subcutaneous or intravenous routes of administration. Previous studies have shown that Emisphere's oral heparin formulation can affect the coagulation cascade in a manner similar to injectable heparin. Should the results from the study be positive, the data could support a claim that heparin is unchanged by the oral route of administration using the Emisphere technology. Emisphere is working to characterize the heparin in the human plasma with Shaker A. Mousa, Ph.D., MBA, FACC, FACB, Director of the Pharmaceutical Research Institute at the Albany College of Pharmacy, and Robert Linhardt, Ph.D., the Constellation Professor of Biocatalysis and Metabolic Engineering at the Rensselaer Polytechnic Institute and Adjunct Professor at the Albany College of Pharmacy. ADVERTISEMENT "The preliminary results of the anticoagulant parameters we have seen to date from the study are as expected," said Michael M. Goldberg, M.D. "The increase in activated partial thromboplastin time (APTT), a key measure of anticoagulant activity, in all subjects who received our oral product is consistent with our previous results, and we believe it could translate into a clinically meaningful effect. We look forward to obtaining the results from the molecular characterization work being conducted by our leading academic experts - Drs. Mousa and Linhardt. We hope to present the final results to the U.S. Food and Drug Administration (FDA) as soon as possible." "To confirm that heparin dosed intravenously or subcutaneously has the same molecular composition as heparin dosed by the oral route utilizing the eligen® technology, an extraction process, similar to that described in the literature (Toida, Edens, Linhardt), followed by several analytical processes, which have been discussed with the FDA, will be used on the human plasma collected. We have evaluated the technique with human plasma from a previous Emisphere clinical trial with the oral Heparin/SNAC product," said Dr. Linhardt. Dr. Mousa added, "Levels of anti-Xa, anti-IIa and tissue factor pathway inhibitor of the subjects will be measured for all study arms allowing Emisphere to confirm that the key pharmacodynamic parameters of heparin, when given by the various routes of administration, are consistent. The results will potentially validate that heparin is unchanged when taken orally in a dosage form utilizing Emisphere's eligen® technology." <snip> biz.yahoo.com

To: Miljenko Zuanic who wrote (229)	11/3/2005 9:13:33 PM
From: hmpa	Respond to of 272

The better chances are with insulin, but this program didn't move forward for last +5 years Probably we'll know its fate in less than 6 months. Press Release Source: Emisphere Technologies, Inc. Emisphere to Commence Phase II Oral Insulin Clinical Trial Thursday November 3, 8:30 am ET TARRYTOWN, N.Y., Nov. 3 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) today announced that it has received permission from regulatory authorities in India to commence a Phase II trial for its oral insulin product. Emisphere intends to initiate patient enrollment later this month for a 90-day, multi-center, double-blind, randomized clinical trial. The four arm study will evaluate the safety and efficacy of low and high doses of oral insulin tablets versus placebo in 120 subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control with their existing oral antidiabetic monotherapy. The primary efficacy endpoint of the study is related to the change in hemoglobin A1c, the standard for evaluating glucose control in Type II diabetics. Emisphere also will focus on the safety of oral insulin, specifically incidents of hypoglycemia as well as the occurrence of insulin antibodies. Emisphere had submitted this Protocol over thirty days ago to the US FDA and is now proceeding with the Trial. "We are pleased to receive the go-ahead from Indian regulatory authorities to conduct our Phase II oral insulin clinical trial, and will begin the study in the coming weeks," commented Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere Technologies. "This marks an important milestone for one of our key, internally developed programs. India has a large diabetic patient population and provides Emisphere, with the help of its locally based CRO, the opportunity to rapidly enroll patients in a cost effective manner. We anticipate that this study will be critical to demonstrating our belief that orally administered insulin is a safe and effective drug for Type II diabetic patients." <snip> biz.yahoo.com