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Anacor Pharmaceuticals Announces Positive Results From Phase 2 Dose-Ranging Study of AN2728 in Adole

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Anacor Pharmaceuticals Announces Positive Results From Phase 2 Dose-Ranging Study of AN2728 in Adolescents With Atopic Dermatitis

Anacor Will Host a Conference Call Today 8am ET / 5am PT to Discuss Results

PALO ALTO, Calif.–(BUSINESS WIRE)– Anacor Pharmaceuticals (NAS: ANAC) today announced positive results from a Phase 2 dose-ranging trial (AN2728-AD-204) of its topical boron-based phosphodiesterase-4 (PDE-4) inhibitor, AN2728. The study included 86 adolescents (ages 12 – 17) with mild-to-moderate atopic dermatitis, a chronic rash which predominantly affects children and is characterized by inflammation and itching. In this study, lesions treated with AN2728 ointment, 2.0% twice daily for 28 days achieved a 71% improvement from baseline in their Atopic Dermatitis Severity Index (ADSI) score, with 66% of lesions in this treatment group achieving total or partial clearance. AN2728 was generally safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug.

“These results demonstrate a clear dose response across the four dosing regimens and identify the AN2728 ointment, 2.0% BID dosing regimen as optimal for a Phase 3 program, which we expect to initiate around the end of 2013,” said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. “In all arms of the study, lesions treated with AN2728 ointment improved throughout the 28 day treatment period. The majority of the improvement occurred within the first week of treatment, which is important to both patients and physicians. AN2728 also continues to demonstrate an excellent safety profile – a key factor in treating this disease that primarily affects children.”

“There is a tremendous clinical need for safe and effective treatments for pediatric atopic dermatitis. It is very exciting to see these promising positive data for a novel molecule with excellent anti-inflammatory properties and that appears very safe to use,” said Lawrence F. Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology and Professor of Pediatrics and Medicine (Dermatology) at Rady Children’s Hospital, University of California, San Diego. “AN2728 has the potential to be an outstanding addition to the treatment armamentarium for physicians and a great benefit to children with atopic dermatitis.”

The Phase 2 randomized, double-blind, bilateral study enrolled adolescent patients with mild-to-moderate atopic dermatitis. Patients were randomized 1:1 to either once daily (QD) or twice daily (BID) application for 28 days. Patients were instructed to apply AN2728 ointment, 2.0% to one target lesion and AN2728 ointment, 0.5% to a comparable target lesion. The primary endpoint was the change from baseline ADSI score, which is …read more
Source: FULL ARTICLE at DailyFinance

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US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™ (Dimethyl Fumarate)

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US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™ (Dimethyl Fumarate)

– Patent Offers Protection Until 2028 and Strengthens Growing Product Patent Portfolio –

– European Patent Office Also Determines Patent Application Covering the Same Dosing Regimen Allowable –

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 8,399,514, which offers additional protection for TECFIDERA™ (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The patent, which will expire in 2028, covers the dosing regimen of daily administration of 480 mg of TECFIDERA. This regimen is included in the proposed marketing application for TECFIDERA, which is currently under review by the U.S. Food and Drug Administration (FDA).

“The patent for this dosing regimen is recognition of the remarkable innovation TECFIDERA represents for the MS community,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “The tremendous research investment required to study and validate the patented dosing regimen is an example of innovation that leads to meaningful benefits to patients.”

The European Patent Office also recently determined that Biogen Idec‘s application for a patent covering the same dosing regimen of TECFIDERA is allowable. Once granted, this patent would also expire in 2028.

The TECFIDERA dose regimen patents add to the growing portfolio of granted patents covering TECFIDERA.

About TECFIDERA

TECFIDERA is the only currently known investigational compound for the treatment of relapsing-remitting multiple sclerosis (RRMS) that has experimentally demonstrated activation of the Nrf-2 pathway. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.

In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg of TECFIDERA, administered either twice a day (BID) or three times a day (TID), for two years. TECFIDERA is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.

About Biogen Idec

…read more
Source: FULL ARTICLE at DailyFinance

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Infinity Provides Company Update and Reports Full-Year 2012 Financial Results

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By Business Wirevia The Motley Fool

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Infinity Provides Company Update and Reports Full-Year 2012 Financial Results

– Cohort Expansions of Phase 1 Trial of IPI-145 in Patients with Advanced Hematologic Malignancies Now Enrolling –

– Key Data Expected from PI3K and Hsp90 Programs in 2013 –

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Infinity Pharmaceuticals, Inc. (NAS: INFI) reported its full-year 2012 financial results and ongoing progress with IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and retaspimycin HCl, its potent and selective inhibitor of heat shock protein 90 (Hsp90), and anticipates reporting clinical data from both these programs this year. Infinity also announced today that it initiated five new expansion cohorts in its trial of IPI-145 in patients with advanced hematologic malignancies.

“We made important progress on our product development goals last year, reporting encouraging preliminary data from our Phase 1 trial of IPI-145 in patients with advanced hematologic malignancies, initiating a Phase 2a trial of IPI-145 in patients with asthma, and completing enrollment in our Phase 2, double-blind, randomized, placebo-controlled trial of retaspimycin HCl in non-small cell lung cancer,” stated Adelene Q. Perkins, Infinity’s president and chief executive officer. “We entered 2013 in a strong financial position with approximately $327 million in cash and investments and anticipate this will be a year of fundamental progress for Infinity, as data generated from our ongoing trials will inform our potential registration paths as we continue building a sustainable, fully-integrated biopharmaceutical company.”

In December 2012, Infinity reported encouraging preliminary data at the Annual Meeting of the American Society for Hematology (ASH) showing clinical activity at each of the doses of IPI-145 evaluated from 8 mg through 75 mg twice daily (BID), indicating a potential broad therapeutic window. Infinity has now defined 75 mg BID as the maximum tolerated dose and has leveraged the adaptive approach of its Phase 1 trial to continue to explore the safety, pharmacokinetics and activity of IPI-145 at 75 mg BID in five additional expansion cohorts of patients with the following hematologic malignancies:

1. Chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma and mantle cell lymphoma
2. T-cell lymphomas
3. Aggressive B-cell lymphomas
4. Myeloid neoplasms
5. T-cell or B-cell acute lymphoblastic leukemia/lymphoma

“We are pleased to have completed the dose-escalation phase of our Phase 1 trial of IPI-145, enabling us to initiate additional expansion cohorts …read more
Source: FULL ARTICLE at DailyFinance