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nLife Therapeutics receives USD 350,000 from The Michael J. Fox Foundation for Parkinson’s Research

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nLife Therapeutics, an early-stage biopharmaceutical company leading developments in nOligos (neuronal specific oligonucleotides) as therapeutic agents for CNS disorders, today announces that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has awarded the company a grant of USD 350,000 (EUR 271,000). nLife will conduct a research study entitled: “Pharmacokinetic and Pharmacodynamic characterization of a novel therapy to silence selectively alpha-synuclein in monoaminergic neurons of rat.”

The money will be used to characterize the pharmacokinetic (distribution of the molecule) and pharmacodynamic (effect on target protein) profiles of NLF-PD-1233, nLife’s lead compound.

This is only the second grant from the MJFF to a Spanish company (as opposed to academia). Since its inception in 2000, the MJFF has awarded more than 1,750 grants worldwide, with 24 of them involving investigators from Spanish organizations.

nLife Therapeutics designed the NLF-PD-1233 molecule to target specific neurons in the brain to reduce expression of the alpha-synuclein protein, a major constituent of Lewy bodies (protein clumps that are the pathological hallmark of Parkinson’s disease). The MJFF-funded project aims to characterize the dose and efficacy of the molecule in an alpha-synuclein overexpression model of Parkinson’s disease (PD) vs. a healthy model. The results are due in November 2015.

The funding enables nLife to study the processes of absorption, distribution, elimination and efficacy of the compound. The primary endpoint of the study is to find a suitable treatment dose for intranasal and direct brain administration. nLife will compare the drug concentrations achieved when given through the nose to those when given directly to the brain or intravenously.

The secondary endpoint will be to characterize the efficacy of NLF-PD-1233, analyzing the knockdown of alpha-synuclein mRNA expression and alpha-synuclein protein changes. Then, the company intends to characterize the concentration-response relationship for NLF-PD-1233 and alpha-synuclein mRNA knockdown. The resulting data will be used to model the projected dose-effect relationships for larger animal models and for humans. Clinical trials could start in December 2015.

“Based on our preclinical findings, we believe NLF-PD-1233 may be able to slow down the progression of PD and relieve motor and non-motor symptoms,” said Andres Montefeltro, CEO at nLife Therapeutics. “If the results are sustained in humans, it could be the first disease-modifying treatment for PD.”

About Parkinson’s disease
Parkinson’s disease is a progressive disorder of the central nervous system, characterized by neuron loss and symptoms including tremor, rigidity, cognitive decline and autonomic dysfunction. Parkinson’s disease has no cure at present, but drugs help to control the symptoms.

The motor symptoms of Parkinson’s are due to a loss of dopaminergic neurons. Current medications aim to supplement dopamine. The most effective medication is levodopa (which is converted into dopamine once it reaches the brain), however this drug loses its efficacy after years of use and dyskinesia (involuntary movements) are observed at high dose.

Another approach is based on the direct administration of dopamine agonists. Although this medication lasts longer, it is less effective than levodopa. More recently, alternative strategies have been marketed focused on the regulation of enzymes directly involved in the dopamine metabolism, but many side effects are observed (e.g. increased dyskinesia, hallucination, headaches).

About alpha-synuclein and Parkinson’s disease
Alpha-synuclein is a protein present in neurons. Its normal function is not fully understood, but researchers believe this protein plays a role regulating synaptic vesicles and on the release of specific neurotransmitters. This protein is a major component of Lewy bodies, which are aggregates characteristic of Parkinson’s disease. Reducing accumulation of alpha-synuclein is one of the main goals for new therapies in Parkinson’s disease.

About nLife’s nOligos technology 
nLife has a unique neuronal specific oligonucleotide delivery technology (nOligos). Oligonucleotides are short nucleic acid polymers designed to bind to specific complementary messenger RNA strands promoting its degradation, which produces a decrease in the levels of specific proteins that become toxic when they accumulate. The targeting technology allows decreasing levels of toxic proteins in only the affected cells, which spares the healthy ones. Targeting is achieved by attaching a neuronal specific chemical ligand to the oligonucleotide. Thus nOligos have the potential to become a disease modifying therapy, and can be applied to un-druggable target proteins, allowing the development of therapies for diseases that might otherwise have no cure.

About nLife Therapeutics 
nLife Therapeutics is an early-stage biopharmaceutical company leading developments in nOligos (neuronal specific oligonucleotides) as therapeutic agents for CNS disorders. nLife has a unique oligonucleotide delivery platform with strong IP protection to target several neurodegenerative conditions.
Its lead candidate (NLF-PD-1233) is a First in Class disease modifying oligonucleotide treatment for Parkinson’s disease (PD). The company has outstanding preclinical data that validates the nOligos Mode of Action in Major Depressive Disorder and PD. The company also has programs targeting Huntington and Alzheimer disease underway.
Founded in 2010 and based in Granada (Spain), nLife has raised a total of USD 11 million since inception. The investors are private Angels and three Spanish VCs: Crossroad Biotech, Caixa Capital Biomed and HealthEquity.
For more information - http://www.n-life.es

Domain Therapeutics appoints Professor Michel Bouvier as chairman of the Scientific Advisory Board

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Domain Therapeutics, a biopharmaceutical company specializing in the research and development of new medicines targeting G protein-coupled receptors (GPCRs), today announces the nomination of Michel Bouvier as chairman of the company’s Scientific Advisory Board.

Michel Bouvier, PhD, is a professor in the Department of Biochemistry and Molecular Medicine at the University of Montreal and also chief executive officer of the Institute for Research in Immunology and Cancer (IRIC). In the coming months, he will work closely with Domain Therapeutics’ management team to assemble a group of academic and industrial peers.

“We are honored that an internationally renowned key opinion leader in GPCRs will advise on the technology and scientific evolution at our company”, said Pascal Neuville, board director and CEO of Domain Therapeutics. “His seminal contributions to our understanding of this major class of drug targets are invaluable and have led to paradigm shifts and the development of new classes of drugs. His remarkable skills in bridging basic research, drug discovery and medical needs will help Domain to reach its future goals and to maintain its leadership in the GPCR area.”

Michel Bouvier contributed to establishing the concept of ligand-biased signalling. He pioneered the use of bioluminescence resonance energy transfer (BRET)-based methods for the study of functional selectivity of GPCRs. These concepts are now integrated in Domain Therapeutics’ platform, BioSens-All(TM).

Professor Bouvier conducted post-doctoral training at Duke University under the direction of Robert Lefkowitz, winner of the 2012 Nobel Prize for Chemistry for his contribution in the GPCR field. Professor Bouvier was awarded the Hans-Selye/Bristol-Myers Squibb chair in Cell and Molecular Biology and the Merck-Frosst award from the Canadian Society of Biochemistry and Molecular & Cell Biology. He now holds the Canada Research Chair in Signal Transduction and Molecular Pharmacology. Professor Bouvier is a fellow of the Canadian Academy of Health Sciences and of the Royal Society of Canada.

“I look forward to helping guide the development of Domain Therapeutics’ research and development programs in the GPCR field”, said Professor Michel Bouvier. “The potential of the technologies assembled by Domain and the achievements made to date are great and constitute the groundwork for the company’s future success.”

About Domain Therapeutics


Domain Therapeutics is a biopharmaceutical company based in Strasbourg, France. It is dedicated to the discovery and early development of small molecules targeting G protein-coupled receptors (GPCRs), one of the most important classes of drug targets. Domain identifies and develops new drug candidates, allosteric modulators and biased ligands through its innovative approach and distinctive technologies.
The company provides access to its technologies through research and collaborative agreements and develops its own pipeline for components up to the stage of optimized lead product for major indications in central nervous system and metabolic disorders. In January 2014, the company established its subsidiary, Domain Therapeutics NA Inc., at the NEOMED Institute in Montreal, Canada.
Find out more - http://www.domaintherapeutics.com

test mail-TxCell to participate at Société Générale Healthcare & Biotechnology Conference, Paris

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A biotechnology company developing innovative, personalized cell-based immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that it will participate at the Société Générale Healthcare & Biotechnology Conference. The conference will be held in Paris on the 24th September 2014.

At the conference, TxCell’s CEO, Damian Marron will give an update on the status and progress for the company's portfolio of economically viable personalized cell-based immunotherapy products in a range of group and one on one meetings with investors.

“The Société Générale Healthcare & Biotechnology Conference is an important date in the calendar for a wide range of investors and as a result will be an ideal occasion to provide updates to investors on the progress of TxCell,” said Damian Marron, CEO, TxCell. “This includes actions TxCell has taken since our introduction on the Paris Euronext markets. We will also discuss developments concerning our innovative proprietary technological platform ASTrIA of personalized cell-based immunotherapies for severe chronic inflammatory and autoimmune diseases.”

About TxCell

TxCell is developing innovative personalized cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary ASTrIA technology platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has completed a phase I/IIa study of its lead product candidate, Ovasave® in refractory Crohn’s disease patients and has reported good tolerability and positive clinical efficacy. The company plans to initiate a phase IIb study in the same patient population. TxCell has a strategic partnership for Ovasave with the Swiss company Ferring International Center. Listed on Euronext-Paris, TxCell, a spin-off of Inserm (France’s National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France. The company has 49 employees based at its headquarters and at its manufacturing site in Besançon.

For more information, please visit www.txcell.com

Practical Information about TxCell shares:
ISIN code FR0010127662
Ticker code TXCL

CleveXel Pharma partners with Guilin Pharmaceutical to develop two new anti-malarial products

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CleveXel Pharma today announces that the company has entered into a new partnering agreement with Guilin Pharmaceutical, a Chinese company located in Shanghai, regarding the development of two new products.

Pharmacy Times Reveals Pharmacists' OTC Favorites

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The 2014 OTC Guide supplement issue, website, and mobile app, touted on the TODAY show, announce the most recommended OTC products in more than 150 categories.

Astellas Details Pipeline Progress at R&D Meeting

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Astellas today announced progress on the Company's efforts to reshape its research framework at its R&D meeting held in Tokyo on July 10. The meeting provided an opportunity for Astellas to present a comprehensive overview of its late-stage clinical programs and corporate strategy. The purpose of the meeting was to provide an update on the initiatives for Astellas innovation, drug discovery research and pipeline progress.

Strativa Pharmaceuticals Announces FDA Approval of Nascobal® (Cyanocobalamin, USP) Nasal Spray Single-Use Device

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One Spray per Device, Without the Need for Priming, Provides Greater Ease of Use

Weight-Loss Surgery, Prescriptions More Satisfying for Obese Patients

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Obese patients who underwent surgery or took medications to lose weight were more satisfied with their results than those who made lifestyle changes.

Japan Approves- Oral, Interferon and Ribavirin Free Hepatitis C Treatment and others

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Offers new treatment option for genotype 1 HCV patients in Japan who are interferon-ineligible/intolerant, or did not previously respond to treatment

Japanese HCV patients in urgent need of care now have opportunity for cure, including older patients and those with compensated cirrhosis

genOway offers industry scientists immediate access to EUCOMM conditional KO mouse models

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genOway guarantees freedom to operate (FTO) and offers important gains in conditional knockout development time for industry scientists

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