Category Archives: Cf

NextGen Crowdfunding is out with some data on the status of Title III Regulation Crowdfunding or Reg CF. NextGen has a tracking application that follows all past and active Reg CF offers. According to their numbers, over $37 million has been raised since the securities exemption kicked in on May 16, 2016. This total includes approximately $4 million in investor commitments for active campaigns that have reached their minimum funding goal. Total Reg CF offers stand at 142 individual campaigns with 113 having successfully closed.The average amount raised under Reg CF that have ended and met their funding goals was about $285,000.

Reg CF currently has a cap of $1,070,000. Until recently the cap was $1 million. There are multiple campaigns that have raised the maximum amount, including:

The first year of Title III data shows that investment crowdfunding is a viable option for many entrepreneurs, startups and small business owners, said NextGen Crowdfunding CEO and Founder Aubrey Chernick. Since launching a year ago with only a handful of campaigns, the industry has seen tremendous growth with commitments continuing to rise each quarter.

Dr. Richard Swart, Chief Strategy Officer of NextGen, said there had been an uptick in activity in both March and April of this year.

[This] suggests that platforms are getting better at helping companies launch. Costs for issuers are also declining, meaning that attorneys and accountants are figuring out more cost effective models to help these firms. These are very positive signs for any company looking to use Title III, explained Swart.

Reg CF allows smaller companies to raise money online from anyone (not just accredited investors). Companies may list offers via FINRA approved crowdfunding portals or Broker-Dealers. This securities exemption, along with Title II (Reg D 506c) and Title IV (Reg A+) of the JOBS Act of 2o12, ushered in a new era of leveraging the internet to connect companies in need of growth funding with investors online.

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NextGen Crowdfunding: Title III, Reg CF Crowdfunding Exceeds $37 ... - Crowdfund Insider

ATLANTA, GA--(Marketwired - May 17, 2017) - Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare pulmonary diseases, announced today the full enrollment of its phase 2b clinical trial testing its flagship anti-inflammatory drug candidate, once-daily oral acebilustat, in adult CF patients (NCT02443688). The study is investigating the potential of acebilustat to reduce lung inflammation and preserve lung function over the course of 48 weeks in CF patients at a high risk for rapid lung function decline. Lung inflammation is still the leading cause of excessive morbidity and premature mortality associated with CF and there are no drugs approved for the treatment of CF lung inflammation. Topline results are expected in mid-2018.

In total, 200 CF patients of all CFTR genotypes across North America and Europe have been enrolled for 48 weeks of treatment comparing 50 mg and 100 mg doses of once-daily oral acebilustat against placebo. In this trial, acebilustat or placebo are being given concomitantly with standard CF care, including CFTR modulator therapies (Orkambi or Kalydeco). In addition to investigating the effect of acebilustat on lung function (FEV1 percent predicted, a standard efficacy readout for CF trials), this trial will also assess the effect of acebilustat on pulmonary exacerbations and patient reported outcomes.

"This acebilustat phase 2b trial has the potential to take the next crucial step in transforming the way we treat underlying pulmonary inflammation in CF patients, which is not currently adequately addressed, even by the best available care today," said Steven Rowe, M.D., Professor of Medicine and the Director of the Cystic Fibrosis Research Center at the University of Alabama at Birmingham, the US Principal Investigator for the study.

The design of this trial enables evaluation of outcomes stratified by patient baseline FEV1 percent predicted, number of pulmonary exacerbations experienced in the year prior to enrollment, and whether the patient is taking concomitant CFTR modulators. The study will also assess inflammation biomarkers closely tied to acebilustat's immunomodulatory mechanism of action, including sputum neutrophil elastase and serum C-reactive protein. Reductions in these inflammatory markers were observed in an earlier trial of once-daily oral acebilustat in CF patients. "If acebilustat exhibits adequate safety and beneficial effects in preserving lung function, the outcome of this trial could herald the coming of a new era for anti-inflammatory treatment of CF patients, one which could change CF patient treatment standards moving forward," said Greg Duncan, Celtaxsys CEO. "The efforts of all the investigators, site staff, and, in particular, the patients enrolled in the study are highly appreciated."

This trial has been made possible by financial and operational support from Cystic Fibrosis Foundation (CFF) Therapeutics, the CFF's nonprofit drug discovery and development affiliate focused on advancing novel therapies for CF patients.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs. Thickened mucus clogs the lungs and serves as a perfect environment to catalyze persistent bacterial colonization of the lungs. Chronic bacterial colonization of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response with the overabundance of neutrophils in the lungs further compromising a patient's breathing capacity. Somewhat paradoxically, excessive production of a neutrophil byproduct, neutrophil elastase, leads to reduced bacterial clearance. Most importantly, elastase is the key driver of irreversible damage to the lungs. Over time, this cycle of infection and inflammation leads to lung function decline and increased pulmonary exacerbations. Lung inflammation is still the leading cause of morbidity and mortality associated with CF leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority. For more information about CF, visit: http://www.cff.org.

About acebilustat (formerly CTX-4430): Acebilustat is a once-daily oral immunomodulatory drug candidate being tested for the treatment of inflammatory diseases. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTA4H and LTB4 have been strongly implicated in the pathogenesis of many diseases involving inflammation, including cystic fibrosis. Acebilustat is presently being evaluated in a CF phase 2b lung function preservation trial, which is supported by the CF Foundation. This trial is assessing acebilustat's potential to preserve CF patient breathing capacity by enhancing airway clearance and reducing the irreversible damage associated with an overactivated neutrophil driven inflammatory immune response.

About Celtaxsys: Celtaxsys, Inc. is a privately-held pharmaceutical discovery and development company focused on advancing medicine to treat patients suffering from rare, orphan designated diseases. The company is developing a sustainable pipeline of first-in-class anti-inflammatory immunomodulators, including its flagship compound, acebilustat (formerly CTX-4430). Our platform of follow-on candidates are covered separately under new intellectual property and exhibit differentiated properties that enable optimization of treatment for other inflammatory diseases. For more information, please visit: http://www.celtaxsys.com.

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Celtaxsys announces full enrollment of its landmark EMPIRE-CF phase 2b clinical trial assessing the potential of ... - Markets Insider

The Chart Readings For CF Industries Holdings, Inc. (CF) Are In NY Stock News CF Industries Holdings, Inc. (CF) has been having a set of eventful trading activity and it is clear from an examination of the charts that traders are now fully aware of the company's key metrics. A deeper exploration of the setup is sure to yield a ... and more »

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The Chart Readings For CF Industries Holdings, Inc. (CF) Are In - NY Stock News

Bicycling

First Ride: Canyon Ultimate WMN CF SLX 9.0 Disc and Endurace WMN CF SL 9.0 Disc Bicycling Two weeks ago, Canyon launched three all-new 2018 women's road bikes: the Ultimate WMN CF SLX carbon road race bike, and the Endurace WMN CF SL carbon endurance model, and the Endurance WMN AL in aluminum. We got a first look, and first ...

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First Ride: Canyon Ultimate WMN CF SLX 9.0 Disc and Endurace WMN CF SL 9.0 Disc - Bicycling

Regulatory Recon: FDA Expands Use of CF Drug; ASCO Abstracts Released (18 May 2017) Posted 18 May 2017 By Zachary Brennan

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Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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Categories: Biologics and biotechnology, Drugs, Medical Devices, US, Canada, Europe, FDA, Health Canada

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Regulatory Recon: FDA Expands Use of CF Drug; ASCO Abstracts Released (18 May 2017) - Regulatory Focus

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The first annual BP 5K run/walk will be held THIS SUNDAY, May 21.

The event will be held at BPHS, with the course going through the nearby neighborhood streets.

Check in for the race is at 9 a.m. at the athletic entrance and the race itself begins at 9:30 a.m. The start and finish line are also at the athletic entrance.

The registration is $10 and includes a race T-shirt.

Water and snacks will be provided at he finish line of the race.

Student organizer of the event, Sabrina Tatalias said, Lots of work goes into planning these types of fundraiser events. I look forward to seeing all of my committees planning and hard work become reality the day of the race!

All proceeds from this event will benefit the Cystic Fibrosis Foundation.

This organization was chosen due to a teacher here at BPHS living with CF.

Interested runners/walkers can register here.

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Run the BP 5K, fight CF - Hawk Eye

Six months ago a Tuam woman could barely climb the stairs without feeling breathless but thanks to a new drug, the Cystic Fibrosis sufferer successfully completed a 620 kilometre cycle from Malin Head to Mizen Head last weekend.

And now Caroline Heffernan has her sights set on participating in a half-ironman in Edinburgh.

She puts her improved health down to the availability of the drug Kalydeco which she said could have provided a lifeline for some of her CF friends who have passed away in recent years.

Mother of two Caroline (46), has been to the forefront of establishing a centre for CF sufferers in the West of Ireland, did not think that she would ever complete such a feat and described it as a very emotional occasion.

One of the highlights of the four day long cycle was when she passed through Tuam and was greeted by well-wishers and members from local cycling clubs. In all the event raised around 100,000 for Cystic Fibrosis awareness.

In total, 45 cyclists took on the challenge from the top of Donegal to the southerly most tip of the country and Caroline says that she didnt realise that there were so hills in the country. She admits struggling for the last 30k but the memory of some of her fellow CF sufferers inspired her on.

I have been very lucky in that I have been given a second chance. Last November I could not climb the stairs at home without being breathless and coughing. In the mornings I would go downstairs with the intention of not having to go back up.

But I was lucky to get on the trial for the drug Kalydeco and within an hour and a half I knew the difference and here we are six months later I have got my fitness back and got my life back.

It means not having to do the normal treatment and I just take two tablets a day and while there is still a lot of work involved, it has changed my life. I was able to do the cycle and while there were a lot of hills involved, it was an emotional rollercoaster, Caroline admits.

The average life expectancy of a CF suffer is 35 years but Caroline has certainly defied these odds and has vowed to continue raising awareness about the condition and how it affects sufferers.

See full story in this weeks Connacht Tribune.

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CF sufferer cycles length of Ireland thanks to wonder drug - Connacht Tribune Group

ARLINGTON, Texas (AP) Texas Rangers center fielder Carlos Gomez is headed to the disabled list and will be sidelined for at least a month with a right hamstring strain.

Gomez underwent an MRI and was examined by team physician Dr. Keith Meister on Monday, when the team was off a day after the outfielder got hurt in a 6-4 victory over Oakland.

The Rangers said Gomez will be out four to six weeks. He will be placed on the 10-day disabled list before Tuesdays game against Philadelphia, when a corresponding move will be made to replace him on the active roster.

Gomez, who had three hits Sunday, scored from second base on Delino DeShields two-out infield single in the seventh inning. Gomez lunged toward the plate to avoid a bat that was still on the ground.

After the game, Gomez said he was going full speed and didnt want to slide because he thought he could get hurt that way.

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Rangers CF Gomez headed to DL with right hamstring strain - FOXSports.com

The Cleveland Indians hope they found the solution to their injury woes in the outfield.

Welcome to The Show, @Bzimmer5. pic.twitter.com/docttMtLTP

The Indians called upBradley Zimmer on Tuesday.Widely regarded as 1A to Francisco Mejias 1B, John Sickels ranked Zimmer hissecond overall Indians prospect,20th overall in his Top 205.

Heres what John had to say about him:

Age 24, hit .250/.365/.425 with 15 homers, 38 steals, 77 walks, but 171 strikeout in 468 at-bats between Double-A and Triple-A; broad range of tools and skills, above-average speed, throwing arm, and raw power he has yet to fully tap; draws walks even when having contact issues, helping his OBP; may not hit for high averages but should be strong secondary average contributor; ETA: late 2017.

Zimmer like his brother, Royals pitching prospect Kyle Zimmer was a first-round MLB Draft pick. The Indians selected Zimmer 21st overall in the 2014 draft out of San Francisco, and now at the age of 24, he is heading to The Show.

The 6-foot-5, 220 pound left-handed bat does a little bit of everything well. While he isnt your traditional five-tool superstar a la Mike Trout, he blends solid defense, decent speed and nice pop into one of the best all-around games in the minors.

Zimmer was slashing .294/.371/.532 over 33 games at Columbus. It was his second stint in Triple-A, neither being enormously large sample sizes, as he appeared in 37 games last season. He added 11 doubles, five home runs and was successful in 9-of-12 stolen base attempts.

His strikeout rate has always been a bit worrisome, and it was no different this season at 29.9 percent. However, he normally balances it with a decent walk rate, sitting at a career 12 percent walk rate entering 2017. This season he is walking just 9.7 percent of the time. Hes also posting a career-best .238 ISO, so perhaps he has been a bit more free-swinging.

MLBFarm.com

2016

MLBFarm.com

2017

Its not fair to think that Zimmer is a .294 hitter, especially when you see his current .405 BABIP. Paired with contact issues in the past, it may also be fair to temper expectations. Zimmer likely won't come in and have a Cody Bellinger debut. That being said there is a lot to like about him He has the tools to be a decent hitter for average, a future 20-20 raker, with solid defense prowess and arm strength.

The Indians arent wasting any time, as Zimmer is set to bat ninth as the starting centerfielder for the Indians in his Tuesday night debut. He has shown the ability to be a top-of-the-order weapon throughout his career. Its scary to think what he could do at the bottom of the lineup hitting into Francisco Lindor and Jason Kipnis.

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MLB Rookie Profile: Bradley Zimmer, CF, Cleveland Indians - Minor League Ball (blog)

This article was originally published on Cyclingnews.com

After dramatically crashing out of the Giro d'Italia during 2016 while fifth overall, Ilnur Zakarin lost out on what would have been the biggest result of his career. The GC specialist has returned to the Giro d'Italia in 2017 with his eyes clearly on a bigger prize.

The 27-year-old Russian rode a Canyon Ultimate at the recent Tour de Romandie in 2017, but also has a choice of the Aeroad model for flatter sprint stages and the Speedmax for time trials.

The eye-catching red and black bike is complemented with a SRAM Red eTap groupset. The wireless electronic groupset operates without cables, with the battery and motors individually located in each of the derailleurs.

The only cables on the groupset run to the front and rear brake respectively and ensures for a tidy and clean looking cockpit.

Zakarin opts for a standard drivetrain combination of 53/39 chainrings, an 11-28 cassette and 172.5 cranks. The crankset is paired with a Quarq power meter.

Zipp provides the 303 wheelset, which is complemented with 25mm Continental Competition ALX tubular tyres.

Click or swipe through the gallery above for a detailed look at the Russians bike.

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Gallery: Ilnur Zakarin's Canyon Ultimate CF SLX - BikeRadar.com