|Idera Announces Initiation of a Phase 2 Trial of IMO-8400; Avanir Announces Accelerated Development Path for AVP-786|
|By Staff and Wire Reports|
|Wednesday, 05 June 2013 18:33|
Idera Pharmaceuticals (NASDAQ: IDRA) announced it has initiated dosing in a randomized, double-blind, placebo-controlled Phase 2 trial of IMO-8400 in patients with moderate to severe plaque psoriasis. IMO-8400, an antagonist of the Toll-like receptors (TLRs) 7, 8, and 9, is a lead clinical candidate in Idera's autoimmune disease program. In a Phase 1 trial involving single escalating doses and multiple doses, IMO-8400 was well tolerated and inhibited TLRs 7, 8, and 9-mediated immune responses. Data from the Phase 1 study will be presented at a scientific meeting in June 2013.
"This Phase 2 trial of IMO-8400 will enable us to evaluate over a 12-week treatment period the continued trajectory of Psoriasis Area Severity Index (PASI) score improvement that we observed in the previous 4-week study of our TLR 7 and 9 antagonist, IMO-3100,” said Robert Arbeit, M.D., Vice President of Clinical Development at Idera. “We anticipate top-line data from the Phase 2 trial of IMO-8400 to be available by the end of 2013.”
“In our proof-of-concept study with IMO-3100 in patients with psoriasis, we observed PASI score improvement, which correlated with significant improvement in psoriasis disease-associated gene profile, including downregulation of the IL-17 pathway. We believe the inclusion of TLR8 activity with IMO-8400 would further enhance the clinical activity observed with IMO-3100 in patients with psoriasis,” said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer of Idera. “We expect that data from the present Phase 2 trial will help inform our decision on further development of IMO-8400 in patients with psoriasis. In addition, during the fourth quarter of 2013, we expect to be in a position to initiate Phase 2 clinical trials in additional autoimmune disease indications, including lupus.”
Avanir Pharmaceuticals (NASDAQ: AVNR) announced the U.S. FDA has agreed to an expedited development pathway for their next-generation compound, AVP-786, requiring only a limited pre-clinical package as part of the Investigational New Drug (IND) application. Upon completion of these preclinical studies the company intends to proceed directly into human clinical trials.
"We are very pleased with the outcome of our recent meeting with the Division of Neurology of the FDA," said Joao Siffert, MD, Avanir's chief scientific officer. "Avanir will be allowed to reference the extensive data generated during AVP-923 development programs in support of the AVP-786 IND and subsequent new drug application. This has the potential to substantially reduce the cost and time to market. We anticipate that we will be able to seamlessly integrate AVP-786 into our ongoing development programs in neuropathic pain, agitation in Alzheimer's disease and levodopa induced dyskinesia in Parkinson's disease."
About AVP-786 AVP-786 is a novel investigational drug product consisting of a combination of deuterium modified dextromethorphan (a new chemical entity or NCE) and ultra-low dose quinidine, used as a metabolic inhibitor. Incorporation of deuterium into specific positions of the dextromethorphan molecule strengthens the chemical bonds and reduces susceptibility to enzyme cleavage and first pass metabolism, but without altering its pharmacology. AVP-786 is an investigational drug not approved by the FDA.
About AVP-923 AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is being studied in several ongoing clinical trials including agitation in Alzheimer's disease, neuropathic pain in Multiple Sclerosis, levodopa-induced dyskinesia in Parkinson's disease, and behavioral symptoms of autism. AVP-923 for the above investigational uses has not been approved by the FDA.
Actinium Pharmaceuticals, Inc. (OTCBB: ATNM), a biopharmaceutical company that develops innovative targeted payload immunotherapeutics for treatment of advanced cancers, announced the timing for a presentation devoted to its Acute Myeloid Leukemia clinical programs.
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced the closing of the previously announced public offering of the Company’s Series A Convertible Preferred Stock (the “Preferred Stock”) and warrants to purchase shares of the Company’s common stock.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has agreed to an expedited development pathway for their next-generation compound, AVP-786, requiring only a limited pre-clinical package as part of the Investigational New Drug (IND) application.
Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced that it has entered into a definitive securities purchase agreement with both existing and new investors to purchase 8.51 million unregistered shares of its common stock and warrants to purchase approximately 4.25 million shares of its common stock.
GenMark Diagnostics, Inc. (NASDAQ: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, will present at the William Blair 33rd Annual Growth Stock Conference to be held at the Four Seasons Hotel in Chicago, IL, on Wednesday, June 12, 2013.
Idera Pharmaceuticals (NASDAQ: IDRA) today announced that it has initiated dosing in a randomized, double-blind, placebo-controlled Phase 2 trial of IMO-8400 in patients with moderate to severe plaque psoriasis.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced a reduction in its workforce as a part of the Company’s efforts to streamline its operations in response to the need to reduce expenses and adapt to changing market conditions.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the Goldman Sachs 34th Annual Global Healthcare Conference on June 12, 2013, at 10:40 a.m. PT in Palos Verdes, CA.
Kamada Ltd. (Nasdaq and TASE: KMDA) today announced the closing of its initial public offering in the United States of 6,420,031 ordinary shares at a price to the public of $9.25 per ordinary share.
Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will present an overview of the Company at 2:00 p.m. PDT on Wednesday, June 12, at the Goldman Sachs 34th Annual Global Healthcare Conference.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully-integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the appointment of Mr. Kurt Gustafson as the Company’s Executive Vice President, Chief Financial Officer, and Principal Accounting Officer effective immediately.
Synageva BioPharma Corp. (NASDAQ:GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, today announced that Sanj K. Patel, President and Chief Executive Officer, will present at the Goldman Sachs 34th Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Wednesday, June 12, 2013, at 9:20 a.m. PDT, and at the Wells Fargo Healthcare Conference in Boston, MA on Tuesday, June 18, 2013, at 3:30 p.m. EDT.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that six abstracts from its cystic fibrosis (CF) program will be presented at the 36th European Cystic Fibrosis Society (ECFS) Conference in Lisbon, Portugal, June 12 to 15, 2013.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will webcast its presentation at the Goldman Sachs 34th Annual Global Healthcare Conference on Tuesday, June 11, 2013 at 10:00 AM (PT).