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Excerpts of fresh editorials of statewide and countrywide hobby from fresh England newspapers:
The providence Journal (R.I.), July sixteen, 2015
Donald Trump’s deplorable screed in opposition t Mexican immigrants (he referred to as them rapists and drug-buyers in his presidential announcement eventual month) has dealt a blow to his now not inconsiderable trade empire. indeed, blue chip brands are severing ties with the actual property magnate at a speedy clip. department advocate chain Macy’s will no longer raise Trump’s company of ties; the PGA will discontinue internet hosting tournaments at a golf path he owns; and the Spanish language television community Univision announced it could not air the Trump-owned leave out u . s . festival.
in every probability the largest blow that Trump has suffered turned into NBC’s announcement that it could sever ties with the GOP candidate. That faculty NBC too will no longer air both the omit u . s . or pass over Universe pageants, and Trump will on no account recrudesce to “The Apprentice.”
actually these businesses are neatly within their rights. Why would respected manufacturers requisite to affiliate themselves with a man who has painted well-nigh every undocumented immigrants from Mexico as criminals?
And yet, in NBC’s case at least, there is more than a touch of hypocrisy. The equal network that dumped Trump nonetheless employs Al Sharpton, who hosts an everyday software on MSNBC, the Peacock community’s 24-hour cable information station.
Sharpton has a much more florid background of making racist and bigoted remarks than does Trump. He’s talked variously of “Chinamen,” ”white interlopers” and “Greek homos,” who stole civilization from Africa. And the reverend has a long history of anti-Semitism, playing a pertinent role in the 1991 Crown Heights insurrection (well-nigh a modern-day pogrom), which killed two. Later, he talked in coded language of “diamond merchants.”
Nor has Sharpton mainly cleaned up his act in fresh years. closing yr, an exhaustive ny instances investigation establish that “Sharpton has regularly sidestepped the kinds of responsibilities most individuals see as inevitable, dote taxes, hire and other expenses.” As of ultimate November, there beget been greater than $four.5 million in federal and situation tax liens against Sharpton and his companies, the instances said. In other phrases, Sharpton continues to fail to live as much as the primary tasks of yankee citizenship. Yet there he is, rewarded by way of NBC with an everyday tv program - and, by the way, commonly invited to the White condo.
anyone can bellow the incorrect thing every now and then. but it seems to us that demagogic ethnic slurs through individuals taking allotment in politics are unacceptable no rely who utters them.
Kennebec Journal (Maine), July 13, 2015
final month’s Supreme court docket determination on equal-sex marriage turned into a monumental and profound second in the fight for marriage equality and equal rights. After years of criminal, political and private appeals, the 5-4 ruling extended to every same-sex couples the rights and protections, and admire and dignity, that the establishment of marriage affords.
but the resolution in Obergefell v. Hodges, notwithstanding momentous and precious of come by together, isn't any more the closing commemorate in marriage equality than Roe v. Wade turned into the remaining be alert in women’s reproductive rights, or the passage of the vote casting Rights Act became the final commemorate on minority enfranchisement.
No, opponents will not concede now that equal-sex marriage is the legislation of the land. as a substitute, they’ll chip away on the edges.
The momentum following the courtroom ruling, then, should be used to combat lower back against those efforts, and to flood the federal Employment Non-Discrimination Act, so the equal protection promised in the constitution is truly realized.
In pushing back on Obergefell v. Hodges, marriage-equality opponents will birth with so-referred to as non secular freedom laws, the kindhearted that beget been scuttled lately in Arizona and Indiana - and as a result dropped in Maine - following an outcry from groups and residents.
These legal guidelines are useless and even detrimental. spiritual freedom is inevitable within the charter, and the perquisite for church buildings and ministers to reject to conduct equal-sex marriage ceremony ceremonies is neatly-dependent.
And for every of the discuss who may be pressured to bake a cake for whom, it's the rights of gays and lesbians, no longer non secular company house owners, that beget been trampled on for years with the complete backing of the legislations. spiritual freedom legal guidelines would most efficacious acquire that character of discrimination greater doubtless, at a time when it is pellucid they may soundless be heading within the other course.
State legislatures received it preempt when they killed these legal guidelines past this 12 months. They shouldn’t let a extra concentrated pains with the aid of conservatives indignant on the Supreme court docket’s same-intercourse marriage ruling resurrect them.
on the identical time, assaults on equal-sex marriage will continue on the federal level.
A constitutional modification banning the rehearse is a pipe dream, however a future courtroom may revisit the problem.
The fresh ruling became as shut because it gets, and the subsequent president might likewise find a way to nominate sever justices. every of the Republican presidential candidates who beget declared to date denounced the Supreme court docket ruling, and every are adversarial to identical-sex marriage.
In that method, the court ruling is more dote a victory in game 1 of the realm collection than a win in the super Bowl.
besides the fact that children, to stick to the activities theme, marriage equality proponents shouldn’t be content material to play protection.
It continues to be felony in 29 states to discriminate on the groundwork of sexual orientation (and in three extra states, on the basis of gender identification).
So whereas gays and lesbians at the second are free to marry in states dote Alabama, Texas, Pennsylvania and Kansas, they could nevertheless be fired if the inaccurate boss sees them kiss their better half goodbye.
The Employment Non-Discrimination Act would acquire this sort of discrimination illegal in every 50 states. simplest then will same-sex couples truly be on equal footing with different married american citizens.
Valley information (N.H.), July 16, 2015
Jeb Bush’s clarion denomination remaining week for americans to travail longer hours turned into issued at a very inopportune second: In July, millions of Bush’s fellow residents are on vacation, resting from their labors and savoring for a welcome change the pleasures of not working. They suspect, although, that that’s only 1 explanation why the embattled American worker is not more likely to rally to this cause.
for those who ignored what might likewise spin into a defining second within the 2016 presidential crusade, Bush told the editorial board of the Union leader that, “My aspiration for the country - and i believe they will achieve it - is four p.c growth as far as the eye can see. Which means they beget to be much more productive, cadaver of workers participation has to upward push from its all-time up to date lows. It potential that individuals requisite to travail longer hours and, through their productivity, gain greater salary for their families. That’s the handiest way we’re going to come by out of this rut that we’re in.”
Bush in consequence issued a bizarre clarification, claiming that he became in simple terms announcing that these half-time worker's who aspire to a full-time job - estimated at 6.5 million - must beget the option to come by one. It is unostentatious from the context that that’s no longer what he become speakme about. If it had been, the aspect became so obvious that it didn't even deserve to be made: nobody would dispute that those that want full-time travail should soundless be in a position to achieve it. additionally, a 4 % pecuniary growth fee - which many economists dependence sheer fantasy anyway - would require that much more individuals than the currently underemployed would beget to travail a lot longer hours.
It’s comprehensible that Bush feels strongly about work. in accordance with The titanic apple instances, due to the fact leaving the governor’s office in Florida in 2007, he has been paid $27 million for giving speeches, serving on corporate boards and consulting for a brace of banks. “I worked consistently and traveled the globe for my customers,” he has noted. “Over these years, my profits expanded because of challenging travail and journey.”
It in every probability has no longer happened to Bush that many regular people would no longer categorize as precise “work” the exercise he describes and that in spite of everything his ardor for pursuing it might possibly be tremendously cooled had been he being paid $12 an hour.
To whatever thing extent american citizens aren't working as long and difficult as Bush would hope, the motives are plain. decent jobs for common individuals are drying up at an alarming rate, wage boom is stagnant for everyone however properly-incomes households and the united states lags at the back of in policies that motivate work, akin to extraordinary and most economical baby custody and paid proceed away.
definitely, americans travail plenty - a classic of 34.4 hours per week in 2013, based on the employer for economic Co-operation and construction. That’s greater than their counterparts in just about every wealthy international locations, together with 30 p.c greater hours than Germans. (only for the record, Donald Trump, Mexicans worked greater than anyone else in 2013, at 43 hours per week, the OECD stated.) It’s likewise price noting that in a 2014 Gallup survey, americans said working a touchstone of forty seven hours per week.
Bush’s remarks had been not, as they beget got been characterized, a gaffe, however fairly another expression of the sotto voce Republican conviction that the united states is a nation of slackers and strivers, and that the previous closely outweigh the latter. they are easily a variant of Mitt Romney’s revelatory comments eventual time around about “the forty seven %” of american citizens who purportedly are based on the govt; who feel they are entitled to fitness care, to meals, to housing, “to you-name-it”; who dependence they are victims; and who don’t pay any income tax. this is a world view that says much more about folks that hang it than it does concerning the americans it disparages.
The Bristol Press (Conn.), July sixteen, 2015
For years now, we’ve heard warnings concerning the outcomes of the “digital divide” - the growing pocket between information superhighway haves and have-nots. bound, there are many who soundless don’t beget connections in their homes and don’t want them (even though, we’re guessing, they don’t actually beget any theory of what their lacking!) however there are some for whom going without isn't a preference and is, in reality, more censorious than missing out on facebook, cat movies and Amazon bargains.
As President Barack Obama defined Wednesday, for college kids (and, we’d add, job-seekers), it’s a twenty first century necessity.
the want of domestic entry to the cyber web without problems contributes to that success pocket that Connecticut has been scuffling with for many years.
Some years ago, the govt pushed to be certain that faculties throughout america beget laptop banks for student use, as well as web connections. linked is a federal application that, Obama stated, is not off course to wire 99 % of okay-12 lecture rooms and libraries with excessive-velocity information superhighway by way of the End of 2017.
on the way to aid, actually, however what about after college? What about homework assignments that require research - and, sure, the kids can proceed to the public library. however how many are animated within comparatively cheap going for walks distance? in the meantime, their friends simplest should proceed browsing and they’re already ahead, additional widening a spot created by way of the nascence lottery. more than ninety percent of households headed via a university graduate beget web access, Obama observed. but fewer than half of low-profits households beget an identical access.
That’s why they had been gratified to spy the president unveil a software to convey quicker web connections to more low-income households, exceptionally to advocate students animated in public and assisted housing live forward in college.
under ConnectHome, the common public, private and nonprofit sectors beget pledged to travail together to give excessive-pace connections and digital contraptions to greater families at abate cost, the associated Press suggested.
the fresh federal application is anticipated to open in 27 cities, including Meriden, Conn. undoubtedly, we’re hoping that it's going to immediately extend every over pertinent Connecticut.
because, as Obama observed, “during this digital age, for those who can apply for a job, hoist a path, pay your expenses … with a faucet of your mobile, the internet is not a luxury. It’s a necessity. You can not link with these days’s economy without having entry to the cyber web.”
Rutland Herald (Vt.), July 10, 2015
a success completion of talks with Iran to curb its nuclear weapons application features to the skill of President Barack Obama to spy beyond the horizon, pursuing his “lengthy video game” and searching past what one observer has referred to as the “perpetual hysterics” of Washington.
Following the announcement of Washington’s deal with Iran, commentators beget begun what looks dote an about-face in their view of Obama’s success as president. simply just a few months in the past, the current record become that Obama turned into suffering the 2nd-time era blues, that the Republican Congress had conveniently stymied him, that every one he may accomplish was flail helplessly as he watched the clock speed down.
The record has modified, and the Iran deal has capped it off with what should be a ancient success. other successes this 12 months consist of a win in Congress to profit fast-song authority for a alternate cope with Pacific nations; a local weather settlement with China; reviving family members with Cuba; action undertaken on immigration; and two landmark Supreme court docket choices assisting Obama’s positions. These beget been the 2nd determination upholding the within your budget custody Act and the determination requiring marriage equality for equal-sex couples.
further, Obama is taking a greater lively and vocal role on the question of criminal justice and violence against African-americans. His eulogy in Charleston, S.C., changed into an inspiring second, satisfying the hopes of american citizens that Obama could lead the nation in addressing the always vexing rigor of race. He continues to flood the ball ahead on considerations of race, and along with his talk over with to a jail in Oklahoma, he has moved it forward on the concern of mass incarceration.
lots of his censorious initiatives beget required an potential to spy the massive photo. From the outset of his presidency, he made it customary that he changed into inclined to meet with their adversaries and to crash free of hostility that had hardened over time. It has taken time, and it has required him to possibility criticism. however Obama has at every times perceived to know what he believes and to know what he wants to accomplish with his presidency.
He resisted the information of his personal advisers in pursuing fitness custody reform at the outset of his presidency, and although his movements provoked fierce resistance, they beget paid off with crucial reforms that the American americans should be reluctant to display far from.
In an extended article on the website Politico, Jon Favreau, a former speechwriter for Obama, talked about, “When it came time to really govern, he establish the history books ahead of the word cycles, and their politics should be if future presidents ensue his instance - because heaps of phrases written when you account that the midterms about how resigned and defeated Obama is now appear as insightful because the feedback portion of a blog.” Favreau turned into the observer who made note of the distracting hysterics that often dominate Washington.
The fierce and apparently unthinking response of Republicans to Obama’s initiatives has stemmed in allotment from the debilitated spot of their position. They understood that if Obamacare took impact, it could develop into customary. therefore, they vital to cancel it before the individuals had an opportunity to improvement from it. in any other case, Obama would notch up a historical victory that could enhance the Democrats’ position for the long run.
The Republicans’ reflexive rejection of the Iran constrict falls in the identical class. The American people are recumbent to see the common sense that peace is superior than battle and that the nation is strong ample to hoist an opportunity on peace. The Republicans are left to bicker that a pact through which Iran gives up the bomb is in reality going to profit them the bomb. it is a wild supposition in response to fear, which is the best controversy Republican critics beget left.
even as a candidate for president in 2008, Obama pursued the long video game, while pals and supporters succumbed to occasional matches about his strategies and method. however he accomplished a ancient success, and as his presidency closes in on its final quarter, the successes are mounting.
The Eagle-Tribune (Mass.), July sixteen, 2015
Such is the faculty of the scientists and engineers who travail for NASA that, after a journey of greater than nine years and three billion miles, the fresh Horizons probe arrived July 14 at its immediate Come across with Pluto seventy two seconds forward of schedule.
obviously, the americans who made this deep-area mission feasible and who're managing it nowadays deserve a circular of applause. The repose of us can hoist a second to indulge in the glow of country wide delight. They may should hitch rides with the Russians to the international region Station but no person - nobody - can suit their skill with unmanned planetary probes.
New Horizons is the fastest automobile ever produced by using humans. Launched from Cape Canaveral, Florida, in 2006 at a pace of 36,373 mph - quickly satisfactory to crash out the photo voltaic gadget - the probe reached Jupiter in exactly 13 months. There, it used the massive planet’s gravity for a route correction and a pace raise. nonetheless under the drag of the solar’s gravity, the probe has slowed just a little. It zipped past Pluto July 14 at roughly 31,000 mph.
New Horizons become built for pace. It lacks the propellant it will should decelerate satisfactory to enter orbit round Pluto. So dote the Pioneer and Voyager missions of the Nineteen Seventies and 1980s, it is a fly-by. fresh Horizons became off its communications with Earth Monday night so it may focus on information collection throughout its 7,200-mile closest system to Pluto. The probe effectively re-centered contact with home on the evening of July 14 and commenced sending back its facts.
New Horizons will continue on to the Kuiper belt, a ring of icy and rocky debris backyard the orbit of Neptune left over from the formation of the solar device. The Kuiper belt is the supply of some comets - those with orbits that deliver them around the sun each 200 years or so. it is likewise the home of Eris, a lately establish dwarf planet nearly as big as Pluto. the invention of Eris in 2005 and its similarity to Pluto helped come by the former ninth planet demoted to dwarf planet popularity.
After investigating any Kuiper belt objects it encounters, fresh Horizons will at eventual be a allotment of Pioneer 10, Pioneer 11, Voyager 1 and Voyager 2 within the tremendous emptiness of interstellar area.
The fabulous photographs of Pluto and its moons as smartly as the reams of facts gathered will hold planetary scientists working for years.
There are definitely some who question the value of the $seven-hundred million mission. but fresh Horizons has provided us with their one possibility to come by a transparent examine this far away world. we're not going to discuss with Pluto once again anytime soon. There are different, extra pleasing places - such as the moons of Jupiter and Saturn - lots closer to domestic.
The one-time Come upon has vastly multiplied their abilities of Pluto. for most of the time since its discovery in 1930, Pluto has been Little more than a brilliant speck relocating slowly against the historical past of stars in its 248-12 months orbit around the solar. more currently, the Hubble house Telescope had been able to unravel Pluto perquisite into a blurry disk. The newest photographs from fresh Horizons display up to now unimagined aspects on the surfaces of Pluto and its biggest moon, Charon. Ice caps, craters, canyons and a occult coronary heart-shaped vicinity can likewise be viewed
but there’s extra cost to fresh Horizons than the assortment of scientific facts and intriguing pictures. The faculty and ingenuity required to execute any such mission are vital to hold. they beget price outdoor the realm of planetary exploration.
and eventually, there's the touchstone satisfaction of exploration itself - a deeply human impulse. fresh Horizons has indeed lived up to its identify, taking mankind somewhere we've certainly not long gone earlier than.
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consuming a excessive-protein weight loss program in center age could boost your haphazard of diabetes and cancer, based on a anatomize published this week within the journal telephone Metabolism. but accomplish not evade meat for too long - the very spy at showed those over 65 want more protein to prick back their mortality possibility.
Insulin-like expand factor 1, or IGF-1, is a protein to your cadaver regarding expand and construction. previous stories beget linked IGF-1 to age-related illnesses, including cancer. Mice and humans with higher levels of IGF-1 frequently beget an improved haphazard of constructing these illnesses.
Scientists accept as proper with protein consumption performs a job in IGF-1 endeavor. consuming much less protein, experiences beget shown, can lead to abate levels of IGF-1 in your physique. So theoretically, protein consumption could be without dilatory linked to disorder incidence and demise.
Researchers analyzed survey records from 6,381 U.S. guys and girls aged 50 and above to advocate in mind the hyperlink between protein, inevitable ailments and mortality.
The spy at members were split into three companies: a excessive-protein group who ate 20% or greater of their daily energy from proteins; a moderate-protein neighborhood who ate 10 to 19% of their energy from proteins; and a low-protein community.
Researchers additionally seemed on the modifications in risk between those aged 50 to sixty five and those over sixty five years ancient.
people between the ages of 50 and 65 who ate a excessive-protein weight loss program had a seventy four% boost in ordinary mortality compared to these within the low-protein group. The meat enthusiasts likewise had 4-fold increased risk of dying from melanoma every the way through the examine's 18-year follow-up.
despite the fact, this haphazard changed into simplest viewed in those that acquired their protein from animal sources similar to meat, eggs and cheese; the link disappeared if the protein got here from flora, such as nuts, seeds and beans.
people who beget been over the age of 65 and ate a high-protein weight loss diagram noticed the opposite effect. Researchers saw a 28% discount in death from every reasons in this group. melanoma deaths in this older, high-protein neighborhood, had been likewise decreased.
analyze members of any age who ate a excessive-protein diet had a five-fold increased possibility of demise from diabetes.
The scientists had IGF-1 records for greater than 2,200 people within the analyze. analyzing this tips, they determined that for each IGF-1 expand of 10 ng/ml, these on a high-protein weight loss program were 9% extra recumbent to die from melanoma than those on a low-protein diet.
The examine authors concluded that lofty ranges of animal proteins trigger increased ranges of IGF-1 and possibly insulin in the body, which ends up in higher mortality for americans a while 50 to 65.
Tumors in mice
Researchers additionally reported on a sever scan, where lab mice were either on a high-protein or a low-protein weight-reduction plan. Mice on the low-protein weight loss program had a lower melanoma fee than these on a high-protein diet, even after being implanted with 20,000 melanoma cells. The low-protein mice additionally had smaller tumors on common than those on a excessive-protein food diagram with the aid of the conclusion of the six-week experiment.
When the mice had been switched from a high-protein eating regimen to a low-protein weight-reduction plan, researchers noticed a 30% lower in their IGF-1 ranges.
“very nearly each person is going to beget a cancer phone or pre-cancer mobilephone in them at some point. The question is: Does it progress?” examine author Valter Longo pointed out in an announcement. “seems probably the most fundamental factors in picking out if it does is protein consumption.”
ingesting more than 10% of your energy from animal proteins in middle age might expand your possibility of demise from ailments akin to cancer and diabetes. but after sixty five, you may wish that added protein to protect your cadaver from fitting frail.
“the vast majority of americans are consuming about twice as a lot proteins as they should," Longo observed. "It seems that the most useful alternate could be to lower the day by day intake of every proteins, but exceptionally animal-derived proteins."
Walter Willett, an epidemiologist at Harvard's college of Public health, says now not lots should be fabricated from this analyze's findings. it be unreasonable to deal with "animal protein" as one class, he says, as fish, chook and beef are every very distinct.
Willett likewise cited that the headline on the clicking liberate associated with this anatomize - "Meat and cheese may be as unsafe for you as smoking" - is a vast overstatement. The researchers didn't comprise facts on smoking of their study.
The Institute of drugs's meals and nutrients Board recommends consuming about 0.8 grams of protein per kilogram of build weight day by day in center age. So a 160-pound grownup may soundless devour about 55 to 60 grams of protein a day.
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TYME’s novel metabolic-based investigational cancer therapy, SM-88, demonstrated encouraging results and a well-tolerated safety profile in a preparatory analysis from a angle II study of patients with advanced pancreatic cancer
TYME is in discussions with the FDA regarding pivotal visitation design for third-line pancreatic cancer based on preparatory results from the TYME-88-Panc angle II trial
TYME partners with the Pancreatic Cancer Action Network’s (PanCAN) “Precision Promise(SM)” program to forward SM-88 pivotal paths for first- and second-line treatment in patients with pancreatic cancer
Initiation of investigator-sponsored angle II visitation using SM-88 as monotherapy in patients with previously-treated high-risk sarcoma expected in 1Q19
TYME expands senior leadership team and research capabilities
Presentation of data from clinical visitation evaluating SM-88 in biochemically recurrent prostate cancer scheduled for Thursday, February 14th at American Society of Clinical Oncology’s (ASCO) 2019 Genitourinary Cancers Symposium
NEW YORK, Feb. 11, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing metabolic-based cancer therapies, today reported its pecuniary and operating results and provided a trade update for the fiscal quarter ended December 31, 2018. Based on encouraging preparatory results from the TYME-88-Panc angle II study, the Company’s lead pipeline candidate SM-88 is touching forward into pivotal trials for first- and second-line treatment of pancreatic cancer in partnership with PanCAN and its “Precision Promise(SM)” program. TYME is likewise in discussions with the FDA to pursue a pivotal path for SM-88 in third-line treatment of pancreatic cancer.
Mr. Steven Hoffman, Chairman and Chief Executive Officer of Tyme Technologies, Inc., stated, “Based on the broad advocate that they beget received during the quarter from pancreatic physicians, patients, and patient advocacy groups, they are excited to forward SM-88 into the next stage of pivotal trials.”
“Pancreatic Cancer is a devastating disease, predicted to be the second cause of cancer death by 2030,”1 said Martin E. Fernandez-Zapico, MD, a Professor of Medicine and Pharmacology at the Department of Oncology at the Mayo Clinic. “In advanced pancreatic cancers, there is an exigent requisite for fresh treatment options. SM-88 represents a fresh therapeutic approach aimed at disrupting the tumor metabolic program."
TYME continues to focus on advancing SM-88 in pancreatic cancer research, while likewise planning for progress into other indications where SM-88 has shown encouraging results and a well-tolerated safety profile in previous clinical testing.
Third Quarter and Key Corporate HighlightsTYME highlights the following developments that took status during the quarter completed December 31, 2018 and through January 2019:
TYME-88-Panc angle II Clinical visitation ResultsTYME announced that its open-label angle II clinical trial, TYME-88-Panc, evaluating SM-88 as an oral monotherapy in end-stage patients with advanced pancreatic cancer, demonstrated encouraging preparatory results and a well-tolerated safety profile. The preparatory TYME-88-Panc angle II results involved 38 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had received a median of two prior systemic therapies and had significant disease related morbidity before receiving TYME’s investigational agent. TYME-88-Panc is a two-stage angle II study intended to determine optimal dosing and assess if early clinical profit supported further progress of SM-88 in pancreatic cancer. This study is being performed under a TYME IND with input from the FDA prior to study initiation. As a angle II, open-label study, the design involved comparison of two dose levels with an independent Data and Safety Monitoring Board determining continuation.
Preliminary results of the first stage of TYME-88-Panc, using information available as of January 6, 2019, demonstrated that 68% of evaluable patients (19 of 28) were alive at a median follow-up of 4.3+ months (with further survival data to be evaluated as the patients and study progress) and that patients likewise avoided significant grade 4/5 toxicities normally associated with touchstone of custody treatments. Median survival had likewise not been reached on an intent-to-treat (ITT) basis, with 60% (23 of 38) of patients soundless alive. In addition, to assess the natural history for survival, as a comparator, in these advanced cancer patients, TYME performed a review of published studies to determine expected patient outcomes in collaboration with PanCAN.
We believe that these outcomes warrant further progress of SM-88. The results compare favorably to the analysis of 19 prospective second-line+ pancreatic cancer trials where the add up to and median reported survival after progressing on second-line therapy was 3 months2 based on reported historical trials.TYME-88-Panc likewise demonstrated monotherapy activity with SM-88 in some patients based on common measures of anti-tumor activity, including computed tomography (CT), positron emission tomography (PET), and reductions in biomarkers carcinoembryonic antigen (CEA), CA-19.9 and circulating tumor cell (CTC) burden.
As of January 6, 2019, the study reported that SM-88 was well tolerated with only 2 out of 31 (6.5%) serious adverse events deemed at least potentially-related to the study drug. These SAEs both occurred in one patient, who continued on the investigational SM-88 treatment.
The 88-Panc research results are from an investigational study. SM-88 is not approved for the treatment of patients with advanced pancreatic cancer.
“I am encouraged by the early signs of efficacy in this research involving this heavily pretreated population of advanced pancreatic cancer patients,” said Allyson Ocean, MD, a pancreatic cancer specialist at fresh York-Presbyterian Hospital/Weill Cornell Medical center and Associate Professor of Medicine at the Weill Medical College of Cornell University. “It’s very difficult to administer therapy in the 3rd-line and beyond setting, so these patients are in desperate requisite of efficacious therapies. Research results to date likewise attest that SM-88 has a favorable toxicity profile so that’s extremely important.”
American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium
At the ASCO GI Meeting in January, TYME presentations, which are available on their website (www.tymeinc.com/data-publications), included:
Phase II visitation of SM-88 in Patients with Metastatic Pancreatic Cancer: preparatory Results of the 1st Stage:
68% of patients were soundless alive at a median of 4.3+ months of ensue up
Clinical profit included stable disease and partial response observed in 47% (8 of 17) of evaluable patients at two-months using PET imaging scans
CTCs, a potential indicator of disease status, decreased in 70% (16 of 23) patients who completed one plenary cycle of treatment
Despite approximately 85% of patients having had two or more prior lines of therapy, SM-88 was safe and well-tolerated in heavily pretreated patients
Designing Clinical Trials in Third-Line+ Pancreatic Cancer:
Patient demand, along with a want of touchstone of care, makes third-line pancreatic cancer treatments a censorious region for further study
Therapeutic consequence must be evaluated in terms of both property and quantity of life
Approximately 10,000 patients annually search third-line or greater treatment for pancreatic cancer and interest continues to grow
Feasibility of SM-88 in Pancreatic Cancer After Multiple Prior Lines & ECOG <2:
In a prospective angle II visitation studying SM-88 in refractory pancreatic ductal adenocarcinoma (PDAC), only one out of 38 patients (2.6%) experienced possibly related SAEs
In a heavily pretreated pancreatic cancer topic population with extensive co-morbidities, SM-88 was well-tolerated. The study data confirms the feasibility of treating patients with ≥ third-line PDAC with SM-88
Phase II Pharmacokinetics of Oral SM-88 in Heavily Pretreated Advanced Pancreatic Ductal Adenocarcinoma:
D,L alpha-metyrosine exhibits predictable pharmacokinetic properties
Concentration-time profile of D,L alpha-metyrosine regimen was similar to expectations based on previous literature
Patients treated with SM-88 are at low risk of experiencing adverse events related to the three adjuvant components
PanCAN’s Novel “Precision Promise(SM)” Adaptive Pivotal Pancreatic Cancer Trials
In 2019, PanCAN’s Precision Promise(SM) plans to launch its adaptive pivotal trials at 14 high-volume pancreatic cancer treatment centers in the United States, which portray some of the nation’s most prestigious medical institutions and oncologists in the field. Initiation of the first adaptive randomized pivotal visitation evaluating SM-88 as second-line monotherapy in patients with pancreatic cancer is expected for the first half of 2019. SM-88 is expected to be evaluated in an adaptive pivotal visitation as a first-line combination therapy with gemcitabine (Gemzar®) and nab-paclitaxel (Abraxane®) in patients with pancreatic cancer. The primary End point of these randomized trials is expected to be overall survival.
SM-88 angle II Prostate Cancer Trial
TYME is nearing enrollment completion of its multi-center, open label angle II study of patients with biomarker-recurrent prostate cancer who beget rising prostate specific antigen (PSA) levels and no radiographically detectable lesions. The Company will provide updated data from this visitation at the 2019 ASCO Genitourinary Cancers Symposium, which will be held February 14-16, 2019.
SM-88 as Maintenance Therapy for Advanced Ewing's Sarcoma Patients and as Salvage Therapy for Sarcoma Patients (HopES)
This is a prospective open-label angle II visitation evaluating the efficacy and safety of SM-88 in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following touchstone primary or palliative treatments for Ewing's sarcoma patients with a lofty risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. The Joseph Ahmed Foundation, a 501(c) not for profit organization is providing funding and patient advocate for this investigator-initiated angle II (HopES) visitation of SM-88 in patients with previously-treated metastatic sarcoma. The visitation is expected to open in the first quarter of 2019.
Corporate DevelopmentsTYME expanded its leadership team and research capabilities with the addition of:
Michele Korfin, a former Kite Pharma and Celgene Corporation executive, joined TYME as its Chief Commercial Officer with over 20 years of sustain in oncology product launches, oncology marketing strategy, commercial sales, market access and government affairs.
Dr. Martin Fernandez-Zapico MD, of the Mayo Clinic in Rochester MN, joined TYME’s Scientific Advisory Board. Dr. Fernandez-Zapico is a Professor of Medicine and Pharmacology in the Department of Oncology at Mayo Clinic, focused on preclinical pancreatic cancer mechanisms.
Dr. Alexander Vandell, PharmD PhD, joined the Company as its Vice President of Clinical Research to oversee preclinical development. Dr. Vandell joined TYME from Daiichi Sanyo where he managed pharmacogenomics, clinical pharmacology and clinical development.
Anticipated Upcoming Key EventsTYME currently expects to provide informational updates or initiation of activities as follows:
Update on SM-88 regulatory 3rd-line pancreatic registrational pathway: first quarter of calendar year 2019
Update SM-88 angle Ib/II clinical results on prostate data at ASCO GU 2019: first quarter of calendar year 2019
Planned start of enrollment for the investigator-initiated angle II visitation of oral SM-88 as maintenance monotherapy in patients with previously-treated metastatic Ewing’s sarcoma and salvage monotherapy in clinically advanced sarcomas: first quarter of calendar year 2019
Initiation of the first PanCAN “Precision Promise(SM)” adaptive pivotal visitation in pancreatic cancer with SM-88 in second-line monotherapy: first half of calendar year 2019
Update on the first stage of TYME-88-Panc angle II data expected in mid-2019
Publication of SM-88’s First in Human Study in a peer-reviewed journal: first half of calendar year 2019
Third Quarter 2019 pecuniary Results:Cash Position: As of the third quarter ended December 31, 2018, the Company had approximately $16.7 million in cash and cash equivalents compared to $21.1 million as of the second quarter ended September 30, 2018. TYME’s operational cash scorch rate for the third quarter of fiscal year 2019 was $5.3 million compared to $4.7 million for the second quarter. The scorch rate, consistent with their previous projections, predominantly reflected costs associated with their ongoing TYME -88-Panc angle II trial, as well as initial costs related to their agreement with PanCAN. Based on current clinical progress plans, TYME expects a cash scorch rate of approximately $5.0 million for the quarter ending March 31, 2019.
Net Loss: Net loss was $8.0 million for the third quarter ended December 31, 2018, or a net loss per basic and diluted share of $0.08, as compared to a net loss of $5.6 million for the third quarter ended December 31, 2017 or a net loss per basic and diluted share of $ 0.06. The expand in losses were due to the expanded clinical activities, primarily the Company’s angle II pancreatic and prostate clinical trials.
TYME has reported its plenary pecuniary results for the quarter ended December 31, 2018 in the Company's Quarterly Report on configuration 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located on the Company’s website under recent SEC filings at ir.tymeinc.com About Advanced Pancreatic CancerAdvanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among every cancer types. Across every patients with pancreatic cancer, relative 5-year survival is 8% and is less than 3% for those with advanced disease.3 The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer - adenocarcinomas, which accounts for approximately 90% of every pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with fresh cases accounting for only 2.1% of every newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.
About SM-88SM-88 is an oral investigational therapy that utilizes a proprietary dysfunctional tyrosine derivative to interrupt the metabolic processes of cancer cells, breaking down the cells’ key defenses and making them vulnerable to oxidative stress and death. Clinical visitation data beget shown that SM-88 has demonstrated encouraging results across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers without serious grade 4/5 adverse events.
About Tyme TechnologiesTyme Technologies, Inc., is a clinical-stage biotechnology company developing cancer therapeutics that are intended to be broadly efficacious across tumor types and beget low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to hoist advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. ensue us on convivial media: @tyme
Forward-Looking Statements/Disclosure NoticeIn addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding their drug candidate SM-88 and its clinical potential and non-toxic safety profiles, their drug progress plans and strategies, ongoing and planned clinical trials, preparatory data results and the therapeutic design and mechanisms of their drug candidates; and readers can identify forward-looking statements by sentences or passages involving the exercise of terms such “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words (including their exercise in the negative) or by discussions of future matters such as the progress and potential commercialization of their lead drug candidate and of other fresh products, expected releases of interim or final data from their clinical trials, viable collaborations, the timing, scope and objectives of their ongoing and planned clinical trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are topic to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, that the information is of a preparatory nature and may be topic to change; uncertainties inherent in research and development, including the faculty to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable fresh clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final angle II data may differ from prior study data or preparatory angle II data; final results of additional clinical trials that may be different from the preparatory data analysis and may not advocate further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may accredit any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could influence commercial availability of SM-88; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on configuration 10-K filed with the U.S. Securities and Exchange Commission on June 13, 2018, as well as subsequent reports they file from time to time with the U.S. Securities and Exchange Commission (available at www.sec.gov).
The information contained in this press release is as of its release date and TYME assumes no responsibility to update forward-looking statements contained in this release as a result of future events or developments.
1Cancer Res; 1–9. ©2014 AACR.2Manax et al 2019 J Clin Oncol 37, 2019 (suppl 4; abstr 226)3Statistics adapted from the American Cancer Society's (ACS) publication, Cancer Facts & Figures 2018.
IR & Media Contact:Ashley R. Robinson LifeSci Advisors, LLC firstname.lastname@example.org
Facing pecuniary difficulties, the Berkeley Unified School District, or BUSD, intends to prick $2 million from its 2019-20 budget, prompting the board to deliberate over exactly how to tighten its belt at its regular meeting Wednesday.
Assistant Superintendent Pauline Follansbee and Associate Superintendent Pasquale Scuderi joined the board to discuss the cuts and presented the superintendent’s proposed reductions. If the recommendation presented were approved without any changes, it would constitute a budget reduction of $2,018,763. The district already reduced ongoing spending by almost $1.8 million eventual year.
“To bellow the least, (the board directors) understand how difficult this job has been … They beget heard the zeal and concern of this community,” said Interim BUSD Board President Beatriz Leyva-Cutler. “However, they every understand that cuts beget to be made in the interest of their district.”
The proposed cuts purview from eliminating vacant positions dote Teachers on Special Assignment and the bare school bus driver position, to restructuring a program which assists homeless youth and reducing transportation costs.
One of the proposed cuts that troubled members of the BUSD Transportation Department is the elimination of a school bus mechanic position, which could compromise student and worker safety. Follansbee said, however, that the district expects to come by eight fresh electric buses and eight fresh gasoline buses, which would require less maintenance than the current ones.
Some of the board members likewise voiced concern about a recommendation that would change the source of funding for some staff positions — including two counselor positions at Berkeley lofty School. The change would add up to that these positions would only be funded for one year and could thereafter be prick altogether.
The board likewise approved a notice of violation to be sent out to REALM Charter School. Among other violations, REALM has not “reimbursed teachers for approved expenditures and has no diagram to accomplish so.” The notice likewise mentioned that a revocation of the charter could occur.
In response to petitions for affordable housing, the board likewise announced that it will spy into structure housing specifically for teachers in their travail session before the meeting. An organization of community members called Berkeley Housing Opportunities for Municipal Employees presented on the housing crisis, providing potential models for future educator housing in Berkeley and suggesting “next steps” for the board, including looking for potential sites and getting advocate from the city.
Board director Ka’Dijah Brown likewise presented a resolution in advocate of the California Schools and Local Communities Funding Act, which would provide an additional $4.5 billion in California public school funding and $5.5 billion for convivial services.
Brown elaborated that BUSD believes that plenary funding of education should be a top priority for the California situation legislature and the governor. She added that the district urges the situation government to advocate for increases in federal special education funding and reform, as well as to advocate staff wages that “address California’s lofty cost of living.”
“It’s no surreptitious that there is a strong requisite for increased situation funding here in California and in their public schools, and their students honestly deserve the best educators and their educators deserve the best and most competitive compensation,” Brown said.
Contact Boyce Buchanan at [email protected] and ensue her on Twitter at @BuchananBoyce.
Shay Zach,Gaia Property Group
Manhattan, NY Shay Zach, formerly of EPIC Commercial Realty, (and now with Gaia Property Group), has sold a residential progress site in the Upper East Side for $23 million. The site, located at 331-337 East 82nd St., is comprised of four vacant residential buildings.
Located between 1st and 2nd Aves., the properties were assembeled by long time client Townhouse Management, and vacated to allow for a fresh 40,000 s/f condo development.
Zach said, “This site got a lot of attention. They had over 15 offers, and prime developers such as Naftali, Elad, DDG, and IGI, were interested in it. Eventually, they achieved a record price per s/f for an Upper East Side progress site setting the bar lofty in that area.”
Zach represented the buyer and the seller, in his former role as associate broker with Epic Commercial. The buyer intends on structure market rate family style condos.
Upper East Side apartment buildings are known for their urbanity and exclusivity, ranging from luxurious residential buildings to sparkling townhouses. The proximity to Museum Mile adds to the attractiveness of the area. Between Central Park and the East River, Upper East Sides boasts a variety of restaurants, stores, and strong retail drive. This reserved and sophisticated neighborhood is within 15 minutes ride to august Central and has simple access to Downtown Manhattan and pecuniary District with MTA [4, 5, 6, E, M, Q] trains as well as local buses.