CEDAR KNOLLS, N.J., April 29, 2010 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (OTCBB:EMIS) today announced that interim data from an ongoing study demonstrated that its high-dose oral Eligen® B12 (1000mcg) given to individuals with low B12 levels restores normal B12 serum concentrations. Normal levels of serum B12 were achieved by all study participants who had taken Eligen® B12 (1000mcg) 15 days into the 90-day study when the first blood samples were taken. Normalization was maintained at all intervals up to and including Day 91. These data, in Abstract Number 8370, were presented on April 28, 2010 at the Experimental Biology 2010 Conference in Anaheim, California, by Dr. Cristina Castelli, Director of Clinical Development at Emisphere Technologies.
In this open-label, randomized, 90-day study, serum cobalamin (B12), holotranscobalamin (active B12), and the two biomarkers, methylmalonic acid and homocysteine, were collected and measured at Baseline, Day 15, Day 31, Day 61 and Day 91. A total of 49 patients were enrolled (26 on IM injection and 23 on oral) and received either nine 1000mcg intramuscular injections of Vitamin B12 or once daily tablets of oral Eligen® B12 (1000mcg). The results from an interim analysis showed that serum cobalamin and active B12 returned to the normal range with both products and normalization was maintained at all intervals up to and including Day 91. Additionally a marked decrease in methylmalonic acid and homocysteine was noted at all time points.
Michael V. Novinski, President and Chief Executive Officer of Emisphere Technologies, noted, "We are highly encouraged by the data generated by this study, which we expect to conclude shortly, pending the last patient last visit. With participants in the oral Eligen® B12 (1000mcg) group showing the ability to rapidly achieve normalized serum and active B12 levels, the study illustrates the tremendous potential of the Eligen® Technology and strengthens our belief that our high dose, oral Eligen® B12 (1000mcg) formulation may offer a much needed medical food alternative to painful and inconvenient IM injections."
As a medical food, Emisphere's Eligen® B12 (1000 mcg) is designed as a specially formulated and processed oral formulation for the dietary management of patients under medical supervision who, because of a limited or impaired capacity to absorb Vitamin B12 , have a diagnosed Vitamin B12 deficiency. It is planned to be available in 2010.
About Vitamin B12
Vitamin B12 is necessary for the formation and maturation of red blood cells and for the synthesis of DNA. It is also necessary for normal nerve function and assists in the body's immune system. B12 deficiency is a major health concern that can lead to anemia, fatigue, weakness, loss of appetite, neurological changes, confusion and dementia.
Unlike most vitamins, B12 is stored in the liver until it is needed by the body. Vitamin B12 is adequately absorbed in the bodies of healthy people, but many older people lose their natural ability to absorb the nutrient. Younger individuals may also have difficulty absorbing B12 as a result of taking certain medications. Those at highest risk for B12 deficiency include anyone over age 60, those with GI tract disorders such as Crohn's Disease, Irritable Bowel Syndrome or Celiac Disease, individuals who have had bypass surgery, those undergoing chronic therapy with absorption-altering drugs, alcoholics and vegetarians/vegans. It is estimated that between 30 and 40 million high-dose injections of B12 are given each year in the U.S. alone and that more than 250 million such injections are given worldwide.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of pharmaceutical compounds, medical foods and dietary supplements using its Eligen® Technology. These molecules and compounds could be currently available or in development. Such molecules are usually delivered by injection; in many cases, their benefits are limited due to poor bioavailability, slow on-set of action or variable absorption. The Eligen® Technology can be applied to the oral route of administration as well other delivery pathways, such as buccal, rectal, inhalation, intra-vaginal or transdermal. The company's website is: www.emisphere.com.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by representatives of Emisphere relating to matters that are not historical facts (including without limitation those regarding the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, the ability of Emisphere and/or its partners to develop, manufacture and commercialize products using Emisphere's drug delivery technology, Emisphere's ability to fund such efforts with or without partners, and other risks and uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 (file no. http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov%2Fcgi-bin%2Fbrowse-idea%3Ffilenum%3D000-17758%26action%3Dgetcompany&esheet=6094507&lan=en_US&anchor=000-17758&index=4&md5=4399dc9737efd84d61d1c0e49ed1b972">000-17758) filed on March 25, 2010.