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Naurex’s GLYX-13 Demonstrates Robust, Sustained Antidepressant Effects and Excellent Tolerability in Phase 2b Study






PHOENIX, Dec. 10, 2014 /PRNewswire/ — Naurex Inc. today announced that Phase 2b data presented at the Annual Meeting of the American College of Neuropsychopharmacology demonstrated that repeat-dose adjunctive treatment along with GLYX-13, a novel NMDA receptor modulator, resulted in robust and sustained antidepressant effects in subjects along with inadequate responses to their current antidepressants. GLYX-13 was well-tolerated along with no drug-related serious edge events reported, including no sign of the psychotomimetic, or psychosis-like, effects associated along with NMDA receptor antagonists such as ketamine. These Brand-new data confirm the efficacy and safety results from an earlier Phase 2 single-dose study of GLYX-13, which likewise documented the drug’s rapid onset of antidepressant activity in as little as two hours.

Unlike most currently approved antidepressants, which act on serotonin and related neurotransmitter pathways in the brain, GLYX-13 works through an entirely different mechanism, mobilizing glutamate pathways to improve neuronal plasticity and improve the communication between neuronal cells. Dysfunction in these activities is increasingly recognized by scientists as an crucial contributor to depression and others serious disorders of the central nervous system (CNS).

“Currently marketed antidepressants all job via similar pathways in the brain and do not adequately treat 45 percent of people along with major depression. This presents a huge problem,” said Sheldon Preskorn, M.D., a study investigator and professor of psychiatry at the University of Kansas School of Medicine-Wichita. “However, there are now several studies showing that lots of of these patients respond to investigational antidepressants, such as GLYX-13, that appear to job via a different mechanism, the NMDA receptor. These Phase 2b data are especially encouraging since repeated treatments along with GLYX-13 make a sustained response in patients that inadequately respond to marketed antidepressants. These results are of excellent clinical importance.”

Norbert Riedel, Ph.D., president and chief executive officer of Naurex, commented, “The inadequacies of existing therapies have actually increased interest in the antidepressant properties of NMDA receptor antagonists adore ketamine, however the serious adverse effects of these drugs limit their practical utility. After evaluating GLYX-13 in over 500 subjects to date, we believe our novel mechanism has actually achieved the right balance in selectively modulating the NMDA receptor to achieve the speed and efficacy of the NMDA receptor antagonists, however devoid of the adverse effects.”

Dr. Riedel continued, “We have actually discussed the wealth of GLYX-13 data along with the FDA and have actually a clear understanding of the Phase 3 trial design called for to file a Brand-new Drug Application and ultimately offer this potentially crucial Brand-new therapy to the millions of patients that are poorly served by current treatments.”

GLYX-13 Phase 2b Study Design
The GLYX-13 Phase 2b study was divided in to three parts: a six-week adaptive-dose treatment stabilization period, followed by a six-week randomized withdrawal period and a four-week wash-out period. The study was made to evaluate safety and efficacy along with repeat dosing and to find out optimal dose (5 mg/kg or 10 mg/kg) and dose intervals (weekly or bi-weekly). Subjects were evaluated for modifications in depressive symptoms on a weekly basis by off-site independent raters using the HDRS-17 scale. Both subjects and evaluators were blind to the study design.

All 386 subjects were dosed along with an intravenous bolus injection of GLYX-13 at the start of the treatment stabilization period. Subjects received weekly injections of drug until a response was established (reduction in HDRS-17 to a score much less compared to or equal to 50 percent of pre-dose baseline). Upon achieving response, subjects were then dosed along with weekly intravenous injections of placebo to force a relapse in depressive symptoms (boost in HDRS-17 to a score better compared to 50 percent of pre-dose baseline). Upon relapse, subjects were again dosed along with GLYX-13 to evaluate whether efficacy could be reestablished. This cycle was repeated along with weekly doses of either GLYX-13 or placebo for 6 weeks. On average, subjects received four injections of GLYX-13 and two injections of placebo throughout this period. This forced relapse component of the design allowed for evaluation of optimal dose interval, the ability of GLYX-13 to reestablish efficacy if the drug were discontinued, and the antidepressant effects of both drug and placebo in each subject.

Subjects that did not respond throughout the stabilization period were excluded prior to the randomized withdrawal period. throughout this six-week withdrawal period, subjects were randomized to keep on receiving GLYX-13 or to have actually the drug withdrawn and replaced along with placebo. throughout the following four-week washout period, all subjects received injections of placebo.

HDRS-17 is a usually used instrument that monitors modifications in subjects’ responses on a number of depressive symptoms such as depressed mode, insomnia, somatic symptoms and difficulty in day-to-day job and activities. The HDRS-17 depression assessment scale was administered to subjects by off-site independent raters.

GLYX-13 Demonstrates Ability to Induce and Reestablish Antidepressant Effect
Overall, GLYX-13 was substantially a lot more effective compared to placebo in alleviating symptoms of depression, it was able to again alleviate symptoms after a forced relapse, and its efficacy in reducing symptoms of depression increased over the course of the treatment period.

Responders demonstrated a considerable difference between responses to drug versus placebo throughout the treatment stabilization period, showing an standard 2.8 point decrease in HDRS-17 scores (improvement of depressive symptoms) in the week after receiving GLYX-13 and an standard 3.1 point increase in HDRS-17 scores (worsening of depressive symptoms) in the week after receiving placebo (p-value = 0.03).

During the treatment stabilization period, reductions in depression scores were compounded incrementally along with each dose of GLYX-13. For subjects responding to GLYX-13, the very first dose of GLYX-13 resulted in an standard reduction in HDRS-17 scores of 4.9 points from baseline; this effect increased to a cumulative standard reduction in HDRS-17 scores of 12.5 points from baseline by the end of the six-week stabilization period.

GLYX-13 Was Well-Tolerated along with Durable Antidepressant Effects
GLYX-13 was found to be well-tolerated throughout the study, along with no drug-related serious edge events and no subjects discontinuing treatment because of drug-related edge events.

A previous Phase 2a study demonstrated that the antidepressant effects of GLYX-13 lasted for an standard of seven days after a single dose; the Phase 2b study data demonstrated that this durable effect continues to build along with repeat doses. Subjects treated along with GLYX-13 throughout the very first six-week treatment stabilization period, then randomized to receive placebo injections, continued to prove to effects of the GLYX-13 treatment throughout the following six-week withdrawal period and the subsequent four-week washout period – never returning toward the baseline HDRS-17 score over the entire post-treatment period. Durability of effect was likewise seen in the subjects that were randomized to keep on GLYX-13 treatment throughout the withdrawal period.

Previous Phase 2a Study Established Rapid Onset of Action
In the Phase 2a study, a considerable reduction in depressive symptoms was seen in as little as two hours following a single injection of GLYX-13 in subjects that had failed treatment along with one or a lot more antidepressant agents. The effect persisted for an standard of seven days. The effect size, a measure of the magnitude of the drug’s antidepressant efficacy, observed at 24 hours and at seven days after a single administration of GLYX-13, was nearly double the effect size seen along with most others antidepressant drugs after four to 6 weeks of repeated dosing.

GLYX-13 to Advance to Phase 3 in 2015
Naurex has actually completed an end-of-Phase 2 meeting along with FDA and is proceeding along with its Phase 3 program, expected to start in 2015.

Naurex recently completed an $80 million Collection C financing to keep on development of GLYX-13 and its next-generation, orally available NMDA receptor modulator NRX-1074, which is completing a Phase 2 study in major depressive disorder. The financing will certainly likewise support advancement of the company’s preclinical NMDA receptor modulators for others CNS indications.

Naurex’s proprietary drug discovery platform is based on the pioneering job of company founder Joseph Moskal, Ph.D. and his colleagues at the Falk Focus for Molecular Therapeutics at Northwestern University. Naurex retains exclusive global development and commercialization rights for the discovery platform and all resulting molecules.

About Naurex Inc.
Naurex is a clinical stage biopharmaceutical company producing transformative therapies for challenging disorders of the central nervous system. The company has actually built a platform for discovering drugs that improve synaptic plasticity, or strengthen the network for neural cell communication. Molecules discovered by Naurex achieve this through a novel mechanism that modulates the NMDA receptor – very compared to shutting it down – resulting in drugs that are both highly effective and well tolerated. Naurex’s lead molecule, GLYX-13, has actually demonstrated rapid, robust, and sustained efficacy in multiple Phase 2 clinical studies in depression, an area of higher unmet requirement that has actually seen little innovation in decades. NRX-1074, a next-generation, orally bioavailable drug candidate, is in Phase 2 clinical development in depression. Naurex’s platform has actually yielded a rich pipeline of subtype-selective NMDA receptor modulators along with the potential to treat a broad set of psychiatric and neurologic disorders.

Media Contacts:
Canale Communications
Ian Stone
ian@canalecomm.com
619-849-5388

Naurex Inc.
Ashish Khanna
Vice President, Corporate Development
corporate@naurex.com
847-871-0377

 

SOURCE Naurex Inc.

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BillingTree’s ‘goodwill’ assisting many community charities including Future for Kids






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PHOENIX, Dec. 9, 2014 /PRNewswire/ — Arizona headquartered BillingTree®, one of the nation’s premier payment solutions providers, announced its latest charitable event sponsorship today. The company will certainly be the presenting sponsor for the December 12thFuture for Youngsters 13th Annual Golf Classic at Whirlwind Golf Club. The event enhances cash to fund educational programs focused on academics, athletics and ethics for at-risk young people.

The charity golf tournament, which features an evening banquet hosted by Miss out on Arizona Alexa Rogers, entails a performance from Arizona singer-songwriter Ashley Wineland. This is the second time BillingTree has actually teamed up along with Future for Youngsters this year – in September the company sponsored the 2014 Youth Basketball Camp at Grand Canyon University.

Additional ‘goodwill’ recipients in 2014 included Florence Crittenton’s Teaming Up For Girls Luncheon and Season for Sharing, the annual holiday campaign of The Arizona Republic, azcentral.com and 12 News, which is a donor-advised fund of the Arizona Community Foundation. BillingTree employees additionally go on utilizing the long-standing company volunteering policy, supplying 3 paid office-hours per month per staff for personal causes. This employer-paid volunteer time regularly entails support for St. Mary’s Meals Bank, Feed My Hungry Children, and several various other organizations totaling over 1800 man-hours per year.

“BillingTree gives a generous percentage of its annual profit along along with hundreds of man-hours thanks to our Board’s philosophy on giving spine to the local community,” commented Scott McCollum, BillingTree’s Chairman. “It’s wonderful to share ‘goodwill’ and go on our job along with so numerous local charities through our employees’ time and sponsoring events enjoy the Future for Youngsters golf tournament.”

For a lot more article regarding getting involved or sponsoring the 13th Annual Golf Classic, interested parties Can easily visit the Future for Youngsters Website.

About Future for Youngsters
For 23 years Futures for Youngsters has actually been inspiring youth through the motto “academics, athletics, ethics.” Its vision is to give vulnerable youth along with the resources for a bright future. Operating along with the support of 600 volunteers Future for Youngsters offers once a week from school enrichment for at-risk youth involving homework help, ethics discussion and health and fitness activities. It additionally runs large-scale sport and health and fitness camps along with professional coaches and athletes, as well as a week-long summer camp focusing on health and fitness and nutrition.

About Founded in 1896, Florence Crittenton of Arizona has actually been dedicated to its mission of giving every girl whose life we touch safety, chance and opportunity. The agency has actually helped foster the recovery of girls and young women that have actually went through periods abuse, neglect, homelessness, poverty, teen pregnancy, drug abuse and/or mental instability. Florence Crittenton’s evidenced-based programs and services give housing, healthcare, education, counseling, and social support to young women and girls, ages 10-to-21. Florence Crittenton holds the charter for the state’s initial and only public, single-gender preparatory school, the Girls Leadership Academy of Arizona (GLAAZ).

About Season for Sharing
Season for Sharing enhances awareness and dollars for non-profit 501(c)3 agencies. Now in its 21st year, Season for Sharing has actually generated a lot more compared to $53 million to guidance local agencies that serve at-risk Youngsters and families, boost educational skills, aid victims of domestic violence and aid older adults. every one of contributions are matched 50 cents on the dollar until donations reach $800,000. Additionally, 100% of every one of funds go to the agencies due to the fact that The Arizona Republic, azcentral.com and 12 News pay every one of administrative and fundraising costs.

About BillingTree
BillingTree’s mission has actually centered about helping companies along with growing their business by delivering cost-effective, compliant payment solutions that enhance and accelerate collections. Committed to and serving the accounts receivable industry for over a decade, BillingTree is the industry leader in the breadth of integrations along with core collection platform units and payment technologies, and in payment compliance. At BillingTree – Your Growth is Our Business. For a lot more information, visit www.mybillingtree.com or call 877.4.BILLTREE.

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Rent-to-Own Real Estate Key to Individual, Societal Economic Well-Being, According to Kinloch Partners, LLC Founder Bruce W. McNeilage






SCOTTSDALE, Ariz., Dec. 5, 2014 /PRNewswire/ — The American Dream of homeownership has actually taken a giant step backward, and unless builders, investors and realtors create Brand-new pathways to ownership, points will certainly only grab worse. However, encouraging younger consumers to buy genuine estate through rent-to-own programs will certainly assistance shore up housing sales and overall genuine estate values, according to investor and developer Bruce W. McNeilage, co-founder of Kinloch Homes LLC.

Speaking here today at the Single Family Rental Forum attended by 800 leading decision makers in the residential genuine estate industry, McNeilage said younger buyers are not investing in genuine estate love their parents and grandparents did. This could have actually long term negative repercussions for people and the economy as a whole.

“Buyers in the so-called Millennial generation are strapped along with student debt, face an uncertain economy overall and are not obtaining married and starting families as early in life as their parents,” McNeilage said. “This is making an entire generation of renters. For most people, their estate is their single biggest asset. Exactly what happens in twenty or 30 years if this group of consumers doesn’t buy? Individually, they will certainly not build wealth and as a nation, our genuine estate values overall will certainly drop. It’s vital that as an industry we look for means to grab younger buyers in to homes.”

Millennials (ages 18-34) have actually seen their student debt jump eightfold compared to consumers of the exact same age in 1989. The standard educational debt among millennials is $16,300, compared to merely $1,900 in 1989. This debt is one of the leading factors in placing off estate purchases. In the very first quarter of 2014, homeownership for Americans 35 and under declined to 36.2 percent, down from 36.8 percent in 2013, according to the U.S. Census Bureau. It is the lowest on tape-record due to the fact that the census’s Housing Vacancy Survey began tabulating homeownership by age in 1982.

However, Zillow.com predicts that millennials want – and will certainly – buy homes.  According to a recent survey by the genuine estate web site, approximately 42 percent of millennials say they wish to buy a estate in the next one to 5 years.

McNeilage, through Kinloch Partners and others genuine estate investment partnerships, currently owns 250 pad all set residential lots in Greater Atlanta and an additional 217 under contract in Nashville and Greater Atlanta. Lots of of the homes on these lots will certainly be rental properties built along with the objective of eventually turning the renters in to buyers. He sees this as an exceptional solution for aiding millennials move from renters to buyers.

“If you put a renter in an apartment, there is little opportunity of turning them in to a buyer,” McNeilage said. “But, if you put them in a estate and job along with them on making a road to ownership, there is a great opportunity they will certainly wish to make it their own. Giving millenials a opportunity to take a trial run as a renter is a Excellent method to grab them to fall in enjoy along with the property and the concept of estate ownership.” 

About Kinloch Partners, LLC

Kinloch Partners, LLC is a genuine estate investment company formed in 2011 by childhood friends Bruce W. McNeilage and Christopher P. Zachary, that met on the playground at Kinloch Elementary School in Dearborn Heights, Michigan, in the mid-1970s.  The company specializes in providing a road to estate ownership for Brand-new homeowners through Brand-new construction, estate renovation or investment in financially distressed genuine estate properties.

SOURCE Kinloch Partners, LLC

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