Navigation Links
Immtech Announces Pafuramidine (DB289) Program on Clinical Hold
Date:12/26/2007

NEW YORK, Dec. 26 /PRNewswire-FirstCall/ -- Immtech Pharmaceuticals, Inc. (Amex: IMM) announced today that it is working with clinical investigators at the 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 following treatment with pafuramidine. The Company has discussed the preliminary findings with the US Food and Drug Administration (USFDA), and as a precautionary measure the pafuramidine program has been placed on clinical hold.

In this South African safety study volunteers were dosed with pafuramidine 100 mg twice daily for 14 days or placebo. The subjects are undergoing close monitoring for any changes in the status of their liver function. No subject has 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 closely with experts and the Data Safety Monitoring Board for pafuramidine."

Carol Olson, M.D., Ph.D., Senior Vice President of Pharmaceutical Development and Chief Officer of Immtech, stated, "This evaluation will continue until patients stabilize or return to baseline status. At that time, Immtech and the independent experts in liver toxicity will prepare a summary of the available safety data and recommendations for presentation to the FDA. The clinical hold may be released after FDA has received satisfactory data regarding the safety of pafuramidine."

This South African study involving healthy volunteers is being conducted to collect additional safety data regarding pafuramidine to support the indications of Pneumocystis pneumonia and African sleeping sickness. This study was planned in 2005, after discussions with USFDA, in order to provide a safety database of appropriate size for submission of these indications to regulatory authorities. These two diseases affect a relatively small number of patients (they are considered as orphan drug indications) and therefore there are fewer patients available than are generally required for Phase three trials. This study was designed to increase the number of subjects treated with pafuramidine.

About Immtech Pharmaceuticals, Inc.

Immtech Pharmaceuticals, Inc. is focused on developing and commercializing drugs to treat infectious diseases. Immtech has advanced clinical programs that include new oral treatments for pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (African sleeping sickness), and a well defined, expanding library of compounds targeting hepatitis C, fungal infections, and bacterial infections. Immtech holds exclusive worldwide licenses to certain patents, patent applications and technology for products derived from a proprietary pharmaceutical platform. For additional information, please go to http://www.immtechpharma.com.

"Safe Harbor" Statement under the Private Securities Reform Act of 1995: Statements in this press release regarding Immtech Pharmaceuticals, Inc.'s business, including the future prospects for PCP, which are not historical facts 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 are not limited to, those discussed under the headings "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" 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 to develop commercially viable products; (ii) Immtech's ability to achieve profitability; (iii) Immtech's ability to retain key personnel; (iv) the ability of Immtech's scientists and collaborators to discover new compounds; (v) the availability of additional research grants; (vi) Immtech's ability to obtain regulatory approval of its drug candidate, including PCP; (vii) the success of Immtech's clinical trials; (viii) dependence upon and contractual relationship with partners; (ix) Immtech's ability to manufacture or to have a third party manufacture its drug candidate at a reasonable cost; (x) Immtech's ability to protect its intellectual property; (xi) competition and alternative technologies; (xii) Immtech's ability to obtain reimbursement from third party payers for any product it commercializes; and (xiii) potential exposure to significant product liability.


'/>"/>
SOURCE Immtech Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Immtech Completes Malaria Prevention Trial
2. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
3. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
4. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
5. HEI, Inc. Announces Sale of RFID Division Assets
6. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
7. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
8. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
9. Brooke Franchise Corporation Announces Selected July Results
10. Manor Care, Inc. Announces Record Date for Special Stockholder Meeting
11. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... ... in a crisis. Her son James, eight, was out of control. Prone to extreme mood ... something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a ... children and say he was going to kill them. If we were driving on ...
(Date:6/24/2016)... San Francisco, CA (PRWEB) , ... June 24, ... ... at CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has ... , self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... People across ... in Genome magazine’s Code Talker Award, an essay contest in which patients and their ... award to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Investment Group (TGIG), has initiated cultivation and processing operations at its production facility, ... Pahrump, Nevada. , Puradigm is the manufacturer of a complete system of proactive ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors ... on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, ... to helping service members that have been wounded in battle and their families. Venture ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016 Revolutionary technology includes multi-speaker ... , industry leaders in advanced audiology and hearing aid ... Opn ™, the world,s first internet connected hearing aid ... devices.      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) ... of ,world firsts,: , TwinLink™ - the ...
(Date:6/23/2016)... -- Research and Markets has announced the ... (United States, China, Japan, Brazil, United Kingdom, Germany, France, ... Surgical Procedure Volumes: ... provides surgical procedure volume data in a geographic context. ... analysis of growth drivers and inhibitors, including world population ...
(Date:6/23/2016)... -- The National Pharmaceutical Council (NPC) today announced that ... organization as its newest member.  ... and chief scientific officer, Mallinckrodt Pharmaceuticals, will serve ... of Directors. ... in support of our efforts to conduct research ...
Breaking Medicine Technology: