LEXINGTON, MA, December 18, 2007 -- ActivBiotics, Inc. today announced that following a review of strategic options after its clinical trial of Rifalazil failed in peripheral arterial disease patients, the Company is selling all or substantially all of its assets on an “as is” basis through an Assignment for the Benefit of Creditors, process. “The Board of Directors has decided to pursue the sale of the company’s clinical and preclinical drug assets”, said Steven C. Gilman, Ph.D., Chairman of ActivBiotics. “We believe that our anti-inflammatory Phase II drug candidate and our antibacterial library of compounds are of significant value to companies in those therapeutic areas,” added Gilman. Bidding packages have been assembled and are ready to be distributed subject to a potential purchaser entering into a standard form confidentiality agreement.
The Company assets available for sale include:
1. A superoxide dismutase (SOD) mimetic program consisting of two clinical-stage drug candidates, M40403 and M40419, and a library of 250 small molecules which have potential as novel therapeutic agents for the treatment of inflammatory diseases. M40403, which has been studied in approximately 700 patients/subjects, has an active IND, and a protocol on file with the FDA under which a Phase II clinical trial for the treatment of post-operative ileus can be conducted, and a protocol to initiate a Phase II clinical trial for the treatment of oral mucositis. The Company has submitted and expects to shortly receive Orphan Drug Designation status in Europe and has an Orphan Drug application pending with the US FDA for the treatment of oral mucositis in subjects with advanced head and neck cancer. In addition to these indications, the SOD mimetics have potential therapeutic uses in a variety of inflammatory disorders including asthma, chronic obstructive pulmonary disease, and radiation protection, stroke, and ischemia reperfusion injury.
2. An antibacterial library of compounds consisting of approximately 800 small molecules, all new chemical entities (NCEs), which may be developed for the treatment of serious bacterial infections, including complicated skin and skin structure infections, endocarditis, osteomyelitis, foreign-body infections, Clostridium difficile-associated diarrhea (CDAD), as well as peptic ulcer disease due to Helicobacter pylori, and disease due to Chlamydia infections. In addition, these NCEs have the potential to be administered as topical agents for the treatment of acne and for the eradication of Staphylococcus aureus in nasal passages.
3. Rifalazil, a clinical stage compound which has been tested in approximately 600 patients, is a potent antibacterial agent with activity mainly against pathogenic Gram-positive bacteria. Rifalazil was found efficacious in a Phase II Chlamydia STD clinical trial, and, separately, a protocol has been submitted to the FDA to begin a Phase II clinical trial in carotid artery atherosclerosis. Rifalazil has been granted Fast Track designation for the treatment of CDAD. The Company has open INDs to continue rifalazil development for infectious diseases, and atherosclerosis-related disease.
The Company assets available for sale include:
1. A superoxide dismutase (SOD) mimetic program consisting of two clinical-stage drug candidates, M40403 and M40419, and a library of 250 small molecules which have potential as novel therapeutic agents for the treatment of inflammatory diseases. M40403, which has been studied in approximately 700 patients/subjects, has an active IND, and a protocol on file with the FDA under which a Phase II clinical trial for the treatment of post-operative ileus can be conducted, and a protocol to initiate a Phase II clinical trial for the treatment of oral mucositis. The Company has submitted and expects to shortly receive Orphan Drug Designation status in Europe and has an Orphan Drug application pending with the US FDA for the treatment of oral mucositis in subjects with advanced head and neck cancer. In addition to these indications, the SOD mimetics have potential therapeutic uses in a variety of inflammatory disorders including asthma, chronic obstructive pulmonary disease, and radiation protection, stroke, and ischemia reperfusion injury.
2. An antibacterial library of compounds consisting of approximately 800 small molecules, all new chemical entities (NCEs), which may be developed for the treatment of serious bacterial infections, including complicated skin and skin structure infections, endocarditis, osteomyelitis, foreign-body infections, Clostridium difficile-associated diarrhea (CDAD), as well as peptic ulcer disease due to Helicobacter pylori, and disease due to Chlamydia infections. In addition, these NCEs have the potential to be administered as topical agents for the treatment of acne and for the eradication of Staphylococcus aureus in nasal passages.
3. Rifalazil, a clinical stage compound which has been tested in approximately 600 patients, is a potent antibacterial agent with activity mainly against pathogenic Gram-positive bacteria. Rifalazil was found efficacious in a Phase II Chlamydia STD clinical trial, and, separately, a protocol has been submitted to the FDA to begin a Phase II clinical trial in carotid artery atherosclerosis. Rifalazil has been granted Fast Track designation for the treatment of CDAD. The Company has open INDs to continue rifalazil development for infectious diseases, and atherosclerosis-related disease.
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