NEW YORK, Dec. 26 Immtech Pharmaceuticals, Inc.(Amex: IMM) announced today that it is working with clinical investigators atthe South African site where a safety study is in progress for pafuramidine(DB289), an investigational therapy. In preliminary findings from the study,abnormal laboratory values were found in several volunteers followingtreatment with pafuramidine. The Company has discussed the preliminaryfindings with the US Food and Drug Administration (USFDA), and as aprecautionary measure the pafuramidine program has been placed on clinicalhold.
In this South African safety study volunteers were dosed with pafuramidine100 mg twice daily for 14 days or placebo. The subjects are undergoing closemonitoring for any changes in the status of their liver function. No subjecthas required any treatment or hospitalization for the abnormalities to date.
The Company's Chairman and Chief Executive Officer Eric L. Sorkin stated,"Our primary concern is the safety of the patients. We are working closelywith experts and the Data Safety Monitoring Board for pafuramidine."
Carol Olson, M.D., Ph.D., Senior Vice President of PharmaceuticalDevelopment and Chief Officer of Immtech, stated, "This evaluation willcontinue until patients stabilize or return to baseline status. At that time,Immtech and the independent experts in liver toxicity will prepare a summaryof the available safety data and recommendations for presentation to the FDA.The clinical hold may be released after FDA has received satisfactory dataregarding the safety of pafuramidine."
This South African study involving healthy volunteers is being conductedto collect additional safety data regarding pafuramidine to support theindications of Pneumocystis pneumonia and African sleeping sickness. Thisstudy was planned in 2005, after discussions with USFDA, in order to provide asafety database of appropriate size for submission of these indications toregulatory authorities. These two diseases affect a relatively small numberof patients (they are considered as orphan drug indications) and thereforethere are fewer patients available than are generally required for Phase threetrials. This study was designed to increase the number of subjects treatedwith pafuramidine.
About Immtech Pharmaceuticals, Inc.
Immtech Pharmaceuticals, Inc. is focused on developing and commercializingdrugs to treat infectious diseases. Immtech has advanced clinical programsthat include new oral treatments for pneumocystis pneumonia (PCP), malaria,and trypanosomiasis (African sleeping sickness), and a well defined, expandinglibrary of compounds targeting hepatitis C, fungal infections, and bacterialinfections. Immtech holds exclusive worldwide licenses to certain patents,patent applications and technology for products derived from a proprietarypharmaceutical platform. For additional information, please go tohttp://www.immtechpharma.com.
"Safe Harbor" Statement under the Private Securities Reform Act of 1995:Statements in this press release regarding Immtech Pharmaceuticals, Inc.'sbusiness, including the future prospects for PCP, which are not historicalfacts are "forward-looking statements" that involve risks and uncertainties.Actual results could differ materially from these forward-looking statements.Factors that could cause or contribute to such differences include, but arenot limited to, those discussed under the headings "Management's Discussionand Analysis of Financial Condition and Results of Operations" and "RiskFactors" in Immtech's annual report on Form 10-K for the year ended March 31,2007 and in its other SEC filings and include: (i) Immtech's ability todevelop commercially viable products; (ii) Immtech's ability to achieveprofitability; (iii) Immtech's ability to retain key personnel; (iv) theability of Immtech's scientists and collaborators to discover new compounds;(v) th