Arcadia's Nitrogen Use Efficiency Trait Completes FDA EFSE; RedHill Announces Completion of Patient Enrollment in RHB-104 Print E-mail
By William Kent   
Tuesday, 09 June 2015 21:39
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 9, 2015. 
Arcadia Biosciences, Inc. (NASDAQ: RKDA), an agricultural technology company, announced the US Food and Drug Administration (FDA) has completed the Early Food Safety Evaluation (EFSE) process for the plant protein responsible for the company's Nitrogen Use Efficiency (NUE) trait. Completion of this review is a critical milestone in the development of Arcadia's pipeline of 13 nitrogen use efficient crops, four of which are in the latter phases of product development.
The FDA EFSE review supported the conclusion that the functional protein for the NUE trait, alanine aminotransferase, is safe for consumption by humans and animals and would not raise safety concerns if present in the food supply. The EFSE is applicable to all plant species utilizing Arcadia's NUE trait.
"Seed products based on the NUE trait are in development for most major global crops," said Eric Rey, president and CEO of Arcadia Biosciences. "Completion of the EFSE process provides our seed company partners with assurance of gene safety. The core safety data used in the EFSE process will facilitate regulatory approvals for all crops that ultimately will bring this yield-enhancing trait to farmers worldwide."
Conventional crops use only about half of applied nitrogen fertilizer. Much of the remainder moves through the soil and enters ground and surface water systems, or volatilizes into the air as a greenhouse gas 300 times more potent than carbon dioxide. Arcadia's NUE trait was developed to help farmers increase yields while reducing costly fertilizer usage and improving the environmental footprint of agriculture.
Arcadia and its commercial partners are testing crops with the NUE trait at 16 field trials worldwide in 2015. The trait's efficacy has been demonstrated in major crops including rice, wheat, barley, sugarcane and canola. To date, three years of independent field trials of NUE in rice have demonstrated an average yield increase of 27 percent in multiple environments. Field trials of NUE wheat lines over multiple locations and crop seasons demonstrated an average yield increase of 10 percent for the leading lines across a range of nitrogen application rates.
"Coupled with the recent regulatory approval of drought tolerant soybeans in Argentina for our joint venture Verdeca, completion of the EFSE process validates Arcadia's significant capabilities to manage the regulatory framework for new crop traits," Rey said.
The data provided by Arcadia to the FDA in support of the EFSE for the NUE trait is consistent with international regulatory requirements for genetically modified crops and will be utilized by Arcadia and its global partners for future regulatory submissions. Arcadia is currently pursuing an additional EFSE for the HB4 drought tolerance trait being utilized in multiple crops in conjunction with Bioceres SA
RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE:RDHL), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that the last patient has been enrolled in the Phase IIa, proof-of-concept clinical study evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis (RRMS). RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
Seventeen patients were enrolled in the open label Phase IIa study (the CEASE-MS study), which is designed to assess the efficacy and safety of RHB-104 as an add-on therapy to interferon beta-1ain patients suffering from RRMS following 24 weeks of treatment. Patients are evaluated for an additional term of 24 weeks after completing treatment with RHB-104. The primary endpoint of the study is the number of combined unique active lesions after 24 weeks of treatment, as compared to baseline, and secondary endpoints include changes in cytokine levels, Mycobacterium avium subsp. paratuberculosis (MAP) status, relapse rate, Expanded Disability Status Scale (EDSS) and safety and tolerability of RHB-104. The CEASE-MS study is being conducted at two medical centers in Israel and interim results are expected either in the fourth quarter of 2015 or the first quarter of 2016.
Clara Fehrmann, RedHill's Director of Clinical Operations, said: "We are very pleased to have completed patient enrollment in the Phase IIa CEASE-MS study with RHB-104. The CEASE-MS study was initiated following four successful pre-clinical studies and is based on the hypothesis that a bacterially induced dysregulated immune system plays a role in the pathogenesis of multiple sclerosis. We are hopeful that the interim results from the CEASE-MS study, expected in late 2015 or early 2016, will contribute to the understanding of the development of multiple sclerosis and will provide new treatment alternatives for patients suffering from this disease."
RHB-104 is also being evaluated as a treatment for Crohn's disease and is currently undergoing a first Phase III clinical study in the U.S. and other countries (the MAP US study). Interim analysis of the MAP US study is expected in the second half of 2016. The primary endpoint is remission at week 26 of treatment. A second Phase III study with RHB-104 for Crohn's disease is planned in Europe (the MAP EU study) and clinical trial applications have been submitted.
Also Tuesday:  
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced it has completed its capital restructuring in preparation for a national exchange listing via a 1-for-150 reverse split of its common stock effective at the close of trading on Tuesday, June 9, 2015.
Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, and Mumbai, India-based Ipca Laboratories Ltd. (NSE:IPCALAB), today announced that the companies have signed a Letter of Intent (LOI) to establish an agreement for Amyris to supply a key starting material for an active pharmaceutical ingredient to Ipca.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced that it has entered into a definitive agreement to acquire from Blackbird Bio Finance ("BB") University of South Florida's ("Licensor") next generation GVAX vaccine's ("CD40LGVAX") related technologies and know-how for an initial consideration of $2.5 million in cash and $1.75 million in shares of the Company's Common Stock.
CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that it has initiated its first Phase 3 study for PRO 140, the Company's novel self-injectable antibody for the treatment of HIV.
Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the presentation of clinical data from its successful DRM01 Phase 2a trial in patients with acne vulgaris. 
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the installation of a Focal One system under a Revenue-per-procedure ("RPP") contract with the Martini-Klinik at the University Hospital Hamburg-Eppendorf (UKE) in Germany.
FlexPower, Inc. (OTC:FLXP), a California consumer products corporation that makes and markets innovative pain management products, is excited to unveil its new company logo. This logo will be used for both the Company and their signature FlexPower Pain Relief Cream. 
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, today announced that its management will be presenting at the JMP Securities Life Sciences Conference on Tuesday, June 23, 2015 in New York City.
iNeedMD Holdings, Inc. (OTC:NEMD) a medical device development company, is proud to announce the signing of a distribution agreement with Mayar Medical, a leading supplier of medical equipment and devices in Istanbul, Turkey. 
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the Board of Directors of Integra has approved the separation of SeaSpine Holdings Corporation ("SeaSpine") from Integra in the form of a tax-free dividend involving the distribution of all outstanding shares of SeaSpine common stock to holders of Integra common stock. 
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has entered into a strategic alliance with naviHealth, Inc. Headquartered in Nashville, Tennessee, naviHealth is an Awardee Convener under Medicare's Bundled Payments for Care Improvement Initiative (BPCI), an innovative initiative aiming to provide higher quality and more coordinated care at a lower cost to Medicare. 
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today announced the successful first human dosing in a Phase 1 clinical trial of its proprietary protein immunotherapy, PRX003. 
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that data from its clinical development program for the investigational agent andexanet alfa will be highlighted in oral sessions at the upcoming International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress, which is taking place from June 20-25 in Toronto.
SAGE Therapeutics (Nasdaq:SAGE) today announced top-line data from an exploratory clinical trial that indicate a statistically significant improvement from baseline in depression in four women with postpartum depression (PPD) within 24 hours after administration of intravenous SAGE-547 (paired t-test p=0.001). 
VBI Vaccines (Nasdaq:VBIV) announced that it will be presenting at the 2015 BIO International Convention on Wednesday, June 17th at 11:30 AM ET. Adam Buckley, VBI's Vice President of Business Development, will discuss VBI's eVLP and Thermostable LPVā„¢ technologies, as well as opportunities for partnership.
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) informs that Sanofi, in an IR Thematic Conference Call on Diabetes today, gave an update on its plans for Lyxumia(r)  (lixisenatide) and LixiLan.

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