Archemix Announces ARC1779 Data to Be Presented at Upcoming American Society of Hematology (ASH) Annual Meeting, December 6-9, 2008

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 4, 2008 - Archemix Corp., a biotechnology company focused on discovering, developing and commercializing aptamer therapeutics, today announced that data from the company's Phase 2a clinical trial of ARC1779 will be presented at the 50th Annual Meeting of the American Society of Hematology in San Francisco, Calif., December 6 to 9, 2008.

ARC1779, Archemix's lead product candidate, is being developed as an anti-platelet agent for the treatment of a rare, life-threatening blood disorder known as thrombotic microangiopathies, or TMA. TMA includes the various forms of thrombotic thrombocytopenic purpura, or TTP, and hemolytic uremic syndrome, or HUS. In December 2008, Archemix completed enrollment in the Phase 2a clinical trial of ARC1779 in patients suffering from TTP. On August 4, 2008, Archemix submitted an IND for the Phase 2b trial of ARC1779 to the FDA, which included interim safety data from the Phase 2a trial. The IND became effective on September 4, 2008. Currently, one site in the United States is scheduled to begin recruiting patients on December 5, 2008. Archemix also has regulatory approval to conduct the Phase 2b trial in Canada and the United Kingdom and is waiting for regulatory approval in Austria, Switzerland and Italy. ARC1779 for the treatment of TTP has received orphan drug designation from both the FDA and the European Commission.

The schedule and meeting places for the sessions, together with the abstract information, are listed below:

“Anti Von Willebrand Factor Aptamer ARC 1779 for Refractory Thrombotic Thrombocytopenic Purpura”

 

Sunday, December 7, 2008 at 6 p.m.
Session Title: Disorders of Platelet Number or Function
Abstract #2298; Poster Presentation (Poster Board II-392); Hall A
 
“Proof of Concept for the Anti Von Willebrand Factor Aptamer in Patients with Relapsing Thrombotic Thrombocytopenic Purpura (TTP)”

 

Sunday, December 7, 2008 at 6 p.m.
Session Title: Disorders of Platelet Number or Function
Abstract #2290; Poster Presentation (Poster Board II-384); Hall A
 
“The Anti Von Willebrand Factor Aptamer ARC1779 Prevents the Desmopressin-Induced Thrombocytopenia in VWD Type 2B

 

Monday, December 8, 2008 at 5:30 p.m.
Session Title: Disorders of Coagulation or Fibrinolysis
Abstract #3374; Poster Presentation (Poster Board III-456); Hall A
About TMA

Thrombotic microangiopathies, or TMA, is a group of rare blood disorders that occur primarily from the increase of von Willebrand Factor, or vWF, activity, which results in the formation of excessive blood clots which block, or occlude, the arterial circulation and cause injury to key organs, including the brain, heart and kidneys. TMA includes the various forms of thrombotic thrombocytopenic purpura, or TTP, and hemolytic uremic syndrome, or HUS. There is no drug treatment specifically approved for patients with any form of TMA. Based on published case studies, Archemix believes that the mortality rate for patients with TTP, which accounts for most of the patients with TMA, is approximately 20 percent.

About ARC1779

Archemix's lead aptamer product candidate, ARC1779, is a PEGylated aptamer consisting of 40 nucleotides that is administered intravenously. ARC1779 is designed to inhibit the platelet-binding function of a protein called von Willebrand Factor, or vWF. vWF plays a key role in the normal blood clotting process by mediating platelet activity. The body regulates vWF to maintain the normal balance between clotting and bleeding. The increase of vWF can cause disease characterized by excessive clotting, while a deficiency of vWF can cause disease characterized by excessive bleeding. Archemix believes that ARC1779, with its potential to inhibit the function of vWF, could address significant, unmet medical needs in the treatment of patients who are suffering from blood disorders characterized by the increase of vWF.

In March 2007, Archemix completed a Phase 1 clinical trial of ARC1779 in 47 healthy volunteers, in which no serious adverse events were observed. In addition, Archemix observed that vWF activity and platelet function were inhibited in a manner that correlated to the dose and concentration of ARC1779. Archemix believes that the results of this trial demonstrate the mechanism of action of ARC1779 and support the continued development of this aptamer product candidate in patients with TMA. In December 2008, Archemix completed enrollment in the Phase 2a clinical trial of ARC1779 in patients suffering from TTP. On August 4, 2008, Archemix submitted an IND for the Phase 2b trial of ARC1779 to the FDA, which included interim safety data from the Phase 2a trial. The IND became effective on September 4, 2008. Currently, one site in the United States is scheduled to begin recruiting patients on December 5, 2008.

ARC1779 has received orphan drug designation from the U.S. Food and Drug Administration and the European Commission for the treatment of TTP.

About Aptamers

Aptamers are synthetically-derived oligonucleotides, or short nucleic acid sequences, that bind to protein targets with high affinity and specificity and can be designed to have a specified duration of action. Aptamers represent an emerging class of potential therapeutic agents that Archemix believes may have broad application to treat a variety of human diseases.

About Archemix

Archemix is a biotechnology company focused on discovering, developing and commercializing aptamer therapeutics. Using Archemix's processes for discovering aptamers, which are protected by its broad patent portfolio, Archemix is developing aptamer product candidates for rare hematological diseases. In addition, Archemix has licensed its intellectual property to third parties to develop their own aptamer product candidates in other areas. Currently, Archemix's licensees are evaluating five different aptamer product candidates in human clinical trials; two in Phase 2 and three in Phase 1. Archemix has additional partnerships with several pharmaceutical and biotechnology companies, including Merck Serono, Pfizer, Takeda, Eli Lilly and Isis Pharmaceuticals.

 

 

Contact: Yates Public Relations
Barbara Yates, 781-258-6153

 

Posted: December 2008

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