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Excerpts of fresh editorials of statewide and countrywide hobby from New 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 last month) has dealt a blow to his now not inconsiderable business empire. indeed, blue chip brands are severing ties with the real property magnate at a speedy clip. department keep chain Macy’s will no longer raise Trump’s company of ties; the PGA will stop 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 all probability the largest blow that Trump has suffered turned into NBC’s announcement that it could sever ties with the GOP candidate. That ability NBC too will no longer air both the omit u . s . or pass over Universe pageants, and Trump will on no account return to “The Apprentice.”
actually these businesses are neatly within their rights. Why would respected manufacturers need to affiliate themselves with a man who has painted well-nigh all 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 relevant function 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 found that “Sharpton has regularly sidestepped the kinds of responsibilities most individuals see as inevitable, like taxes, hire and other expenses.” As of ultimate November, there have been greater than $four.5 million in federal and state 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 say the incorrect thing every now and then. but it seems to us that demagogic ethnic slurs through individuals taking part 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 all 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 get together, isn't any more the closing observe in marriage equality than Roe v. Wade turned into the remaining be aware in women’s reproductive rights, or the passage of the vote casting Rights Act became the final observe 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 flow 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 kind that have 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 certain within the charter, and the right for church buildings and ministers to refuse to conduct equal-sex marriage ceremony ceremonies is neatly-dependent.
And for all 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 have been trampled on for years with the complete backing of the legislations. spiritual freedom legal guidelines would most effective make that type of discrimination greater doubtless, at a time when it is clear they may still be heading within the other course.
State legislatures received it appropriate when they killed these legal guidelines past this 12 months. They shouldn’t let a extra concentrated effort 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 practice 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 also find a way to nominate distinct justices. all of the Republican presidential candidates who have declared to date denounced the Supreme court docket ruling, and all are adversarial to identical-sex marriage.
In that method, the court ruling is more like 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 moment are free to marry in states like 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 make this sort of discrimination illegal in all 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 name remaining week for americans to work 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 also turn 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 have to be much more productive, body of workers participation has to upward push from its all-time up to date lows. It potential that individuals need to work longer hours and, through their productivity, gain greater salary for their families. That’s the handiest way we’re going to get out of this rut that we’re in.”
Bush in consequence issued a fantastic 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 have the option to get one. It is plain 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 work should still be in a position to achieve it. additionally, a 4 % financial growth fee - which many economists trust sheer fantasy anyway - would require that much more individuals than the currently underemployed would have to work a lot longer hours.
It’s comprehensible that Bush feels strongly about work. in accordance with The big 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 couple of banks. “I worked consistently and traveled the globe for my customers,” he has noted. “Over these years, my profits expanded because of challenging work and journey.”
It in all 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 care and paid go away.
definitely, americans work plenty - a normal 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 all 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 also price noting that in a 2014 Gallup survey, americans said working a standard of forty seven hours per week.
Bush’s remarks had been not, as they have 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 last 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 trust 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 hole between information superhighway haves and have-nots. bound, there are many who still don’t have connections in their homes and don’t want them (even though, we’re guessing, they don’t actually have any theory of what their lacking!) however there are some for whom going without isn't a choice and is, in reality, more critical 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 lack of domestic entry to the cyber web without problems contributes to that success hole that Connecticut has been scuffling with for many years.
Some years ago, the govt pushed to be sure that faculties throughout america have 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 go to the public library. however how many are living within comparatively cheap going for walks distance? in the meantime, their friends simplest should go browsing and they’re already ahead, additional widening a spot created by way of the beginning lottery. more than ninety percent of households headed via a university graduate have web access, Obama observed. but fewer than half of low-profits households have an identical access.
That’s why they had been happy to look the president unveil a software to convey quicker web connections to more low-income households, exceptionally to support students living in public and assisted housing live forward in college.
under ConnectHome, the general public, private and nonprofit sectors have pledged to work together to give excessive-pace connections and digital contraptions to greater families at decrease cost, the associated Press suggested.
the new federal application is anticipated to begin in 27 cities, including Meriden, Conn. undoubtedly, we’re hoping that it's going to immediately extend all over relevant Connecticut.
because, as Obama observed, “during this digital age, for those who can apply for a job, take a path, pay your expenses … with a faucet of your mobile, the internet is not a luxury. It’s a necessity. You can not join 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 look 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 have begun what looks like an about-face in their view of Obama’s success as president. simply just a few months in the past, the prevailing story become that Obama turned into suffering the 2nd-time period blues, that the Republican Congress had conveniently stymied him, that every one he may do was flail helplessly as he watched the clock run down.
The story 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 have been the 2nd determination upholding the within your budget Care 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 difficulty of race. He continues to flow 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 critical initiatives have required an potential to look 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 break free of hostility that had hardened over time. It has taken time, and it has required him to possibility criticism. however Obama has at all times perceived to know what he believes and to know what he wants to do with his presidency.
He resisted the information of his personal advisers in pursuing fitness care reform at the outset of his presidency, and although his movements provoked fierce resistance, they have paid off with crucial reforms that the American americans should be reluctant to show 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 put the history books ahead of the news cycles, and their politics should be if future presidents follow his instance - because heaps of phrases written when you consider 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 part from the weak spot of their position. They understood that if Obamacare took impact, it could develop into customary. therefore, they vital to kill 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 contract falls in the identical class. The American people are prone to see the common sense that peace is superior than battle and that the nation is strong ample to take an opportunity on peace. The Republicans are left to argue 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 argument Republican critics have 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 ability of the scientists and engineers who work for NASA that, after a journey of greater than nine years and three billion miles, the new Horizons probe arrived July 14 at its close 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 rest of us can take a second to indulge in the glow of country wide delight. They may should hitch rides with the Russians to the international area 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 break 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 like the Pioneer and Voyager missions of the Nineteen Seventies and 1980s, it is a fly-by. New Horizons became off its communications with Earth Monday night so it may focus on information collection throughout its 7,200-mile closest method 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 also the home of Eris, a lately found dwarf planet nearly as large as Pluto. the invention of Eris in 2005 and its similarity to Pluto helped get the former ninth planet demoted to dwarf planet popularity.
After investigating any Kuiper belt objects it encounters, New Horizons will at last be a part 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 New Horizons has provided us with their one possibility to get 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 bright 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 right into a blurry disk. The newest photographs from New Horizons show up to now unimagined aspects on the surfaces of Pluto and its biggest moon, Charon. Ice caps, craters, canyons and a mysterious coronary heart-shaped vicinity can also be viewed
but there’s extra cost to New Horizons than the assortment of scientific facts and intriguing pictures. The ability and ingenuity required to execute any such mission are vital to hold. they have price outdoor the realm of planetary exploration.
and eventually, there's the standard satisfaction of exploration itself - a deeply human impulse. New 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 chance of diabetes and cancer, based on a analyze published this week within the journal telephone Metabolism. but do not evade meat for too long - the same look at showed those over 65 want more protein to cut back their mortality possibility.
Insulin-like increase factor 1, or IGF-1, is a protein to your body regarding increase and construction. previous stories have linked IGF-1 to age-related illnesses, including cancer. Mice and humans with higher levels of IGF-1 frequently have an improved chance of constructing these illnesses.
Scientists accept as true with protein consumption performs a job in IGF-1 endeavor. consuming much less protein, experiences have shown, can lead to decrease levels of IGF-1 in your physique. So theoretically, protein consumption could be without delay linked to disorder incidence and demise.
Researchers analyzed survey records from 6,381 U.S. guys and girls aged 50 and above to keep in mind the hyperlink between protein, certain ailments and mortality.
The look 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 also had 4-fold increased risk of dying from melanoma all the way through the examine's 18-year follow-up.
despite the fact, this chance 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 have been over the age of 65 and ate a high-protein weight loss plan noticed the opposite effect. Researchers saw a 28% discount in death from all reasons in this group. melanoma deaths in this older, high-protein neighborhood, had been also 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 increase of 10 ng/ml, these on a high-protein weight loss program were 9% extra prone to die from melanoma than those on a low-protein diet.
The examine authors concluded that high 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 separate 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 plan 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 have 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 increase your possibility of demise from ailments akin to cancer and diabetes. but after sixty five, you may wish that added protein to protect your body 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 all 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 all very distinct.
Willett also cited that the headline on the clicking liberate associated with this analyze - "Meat and cheese may be as dangerous for you as smoking" - is a vast overstatement. The researchers didn't include 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 physique weight day by day in center age. So a 160-pound grownup may still devour about 55 to 60 grams of protein a day.
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NEW YORK, Feb. 11, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing metabolic-based cancer therapies, today reported its financial and operating results and provided a business update for the fiscal quarter ended December 31, 2018. Based on encouraging preliminary results from the TYME-88-Panc Phase II study, the Company’s lead pipeline candidate SM-88 is moving 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 also 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 support that they have received during the quarter from pancreatic physicians, patients, and patient advocacy groups, they are excited to advance 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 urgent need for new treatment options. SM-88 represents a new therapeutic approach aimed at disrupting the tumor metabolic program."
TYME continues to focus on advancing SM-88 in pancreatic cancer research, while also planning for development 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 place during the quarter completed December 31, 2018 and through January 2019:
TYME-88-Panc Phase II Clinical Trial ResultsTYME announced that its open-label Phase II clinical trial, TYME-88-Panc, evaluating SM-88 as an oral monotherapy in end-stage patients with advanced pancreatic cancer, demonstrated encouraging preliminary results and a well-tolerated safety profile. The preliminary TYME-88-Panc Phase 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 Phase II study intended to determine optimal dosing and assess if early clinical benefit supported further development 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 Phase 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 also avoided significant grade 4/5 toxicities normally associated with standard of care treatments. Median survival had also not been reached on an intent-to-treat (ITT) basis, with 60% (23 of 38) of patients still 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 justify further development of SM-88. The results compare favorably to the analysis of 19 prospective second-line+ pancreatic cancer trials where the mean and median reported survival after progressing on second-line therapy was 3 months2 based on reported historical trials.TYME-88-Panc also 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 New York-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor of Medicine at the Weill Medical College of Cornell University. “It’s very hard to administer therapy in the 3rd-line and beyond setting, so these patients are in desperate need of effective therapies. Research results to date also indicate 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 trial of SM-88 in Patients with Metastatic Pancreatic Cancer: Preliminary Results of the 1st Stage:
Designing Clinical Trials in Third-Line+ Pancreatic Cancer:
Feasibility of SM-88 in Pancreatic Cancer After Multiple Prior Lines & ECOG <2:
Phase II Pharmacokinetics of Oral SM-88 in Heavily Pretreated Advanced Pancreatic Ductal Adenocarcinoma:
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 represent some of the nation’s most prestigious medical institutions and oncologists in the field. Initiation of the first adaptive randomized pivotal trial 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 trial 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 Phase II Prostate Cancer Trial
TYME is nearing enrollment completion of its multi-center, open label Phase II study of patients with biomarker-recurrent prostate cancer who have rising prostate specific antigen (PSA) levels and no radiographically detectable lesions. The Company will provide updated data from this trial 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 Phase II trial 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 standard primary or palliative treatments for Ewing's sarcoma patients with a high 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 support for this investigator-initiated Phase II (HopES) trial of SM-88 in patients with previously-treated metastatic sarcoma. The trial is expected to begin in the first quarter of 2019.
Corporate DevelopmentsTYME expanded its leadership team and research capabilities with the addition of:
Anticipated Upcoming Key EventsTYME currently expects to provide informational updates or initiation of activities as follows:
Third Quarter 2019 Financial 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 burn rate for the third quarter of fiscal year 2019 was $5.3 million compared to $4.7 million for the second quarter. The burn rate, consistent with their previous projections, predominantly reflected costs associated with their ongoing TYME -88-Panc Phase II trial, as well as initial costs related to their agreement with PanCAN. Based on current clinical development plans, TYME expects a cash burn 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 increase in losses were due to the expanded clinical activities, primarily the Company’s Phase II pancreatic and prostate clinical trials.
TYME has reported its full financial results for the quarter ended December 31, 2018 in the Company's Quarterly Report on Form 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 all cancer types. Across all 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 all pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all 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 trial data have 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 effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take 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. Follow us on social 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 development plans and strategies, ongoing and planned clinical trials, preliminary 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 use of terms such “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words (including their use in the negative) or by discussions of future matters such as the development and potential commercialization of their lead drug candidate and of other new products, expected releases of interim or final data from their clinical trials, possible 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 subject 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 preliminary nature and may be subject to change; uncertainties inherent in research and development, including the ability to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final Phase II data may differ from prior study data or preliminary Phase II data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support 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 approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 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 obligation 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 email@example.com
Facing financial difficulties, the Berkeley Unified School District, or BUSD, intends to cut $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 last year.
“To say the least, (the board directors) understand how difficult this task has been … They have heard the passion and concern of this community,” said Interim BUSD Board President Beatriz Leyva-Cutler. “However, they all understand that cuts have to be made in the interest of their district.”
The proposed cuts range from eliminating vacant positions like Teachers on Special Assignment and the empty 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 get eight new electric buses and eight new gasoline buses, which would require less maintenance than the current ones.
Some of the board members also voiced concern about a recommendation that would change the source of funding for some staff positions — including two counselor positions at Berkeley High School. The change would mean that these positions would only be funded for one year and could thereafter be cut altogether.
The board also 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 plan to do so.” The notice also mentioned that a revocation of the charter could occur.
In response to petitions for affordable housing, the board also announced that it will look into building housing specifically for teachers in their work 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 support from the city.
Board director Ka’Dijah Brown also presented a resolution in support 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 social services.
Brown elaborated that BUSD believes that full funding of education should be a top priority for the California state legislature and the governor. She added that the district urges the state government to advocate for increases in federal special education funding and reform, as well as to support staff wages that “address California’s high cost of living.”
“It’s no secret that there is a strong need for increased state 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 follow 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 development 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 new 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 development site setting the bar high in that area.”
Zach represented the buyer and the seller, in his former role as associate broker with Epic Commercial. The buyer intends on building market rate family style condos.
Upper East Side apartment buildings are known for their elegance and exclusivity, ranging from luxurious residential buildings to beautiful 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 quiet and sophisticated neighborhood is within 15 minutes ride to Grand Central and has easy access to Downtown Manhattan and Financial District with MTA [4, 5, 6, E, M, Q] trains as well as local buses.
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NCIDQ [1 Certification Exam(s) ]
NCLEX [2 Certification Exam(s) ]
Network-General [12 Certification Exam(s) ]
NetworkAppliance [39 Certification Exam(s) ]
NI [1 Certification Exam(s) ]
NIELIT [1 Certification Exam(s) ]
Nokia [6 Certification Exam(s) ]
Nortel [130 Certification Exam(s) ]
Novell [37 Certification Exam(s) ]
OMG [10 Certification Exam(s) ]
Oracle [279 Certification Exam(s) ]
P&C [2 Certification Exam(s) ]
Palo-Alto [4 Certification Exam(s) ]
PARCC [1 Certification Exam(s) ]
PayPal [1 Certification Exam(s) ]
Pegasystems [12 Certification Exam(s) ]
PEOPLECERT [4 Certification Exam(s) ]
PMI [15 Certification Exam(s) ]
Polycom [2 Certification Exam(s) ]
PostgreSQL-CE [1 Certification Exam(s) ]
Prince2 [6 Certification Exam(s) ]
PRMIA [1 Certification Exam(s) ]
PsychCorp [1 Certification Exam(s) ]
PTCB [2 Certification Exam(s) ]
QAI [1 Certification Exam(s) ]
QlikView [1 Certification Exam(s) ]
Quality-Assurance [7 Certification Exam(s) ]
RACC [1 Certification Exam(s) ]
Real-Estate [1 Certification Exam(s) ]
RedHat [8 Certification Exam(s) ]
RES [5 Certification Exam(s) ]
Riverbed [8 Certification Exam(s) ]
RSA [15 Certification Exam(s) ]
Sair [8 Certification Exam(s) ]
Salesforce [5 Certification Exam(s) ]
SANS [1 Certification Exam(s) ]
SAP [98 Certification Exam(s) ]
SASInstitute [15 Certification Exam(s) ]
SAT [1 Certification Exam(s) ]
SCO [10 Certification Exam(s) ]
SCP [6 Certification Exam(s) ]
SDI [3 Certification Exam(s) ]
See-Beyond [1 Certification Exam(s) ]
Siemens [1 Certification Exam(s) ]
Snia [7 Certification Exam(s) ]
SOA [15 Certification Exam(s) ]
Social-Work-Board [4 Certification Exam(s) ]
SpringSource [1 Certification Exam(s) ]
SUN [63 Certification Exam(s) ]
SUSE [1 Certification Exam(s) ]
Sybase [17 Certification Exam(s) ]
Symantec [134 Certification Exam(s) ]
Teacher-Certification [4 Certification Exam(s) ]
The-Open-Group [8 Certification Exam(s) ]
TIA [3 Certification Exam(s) ]
Tibco [18 Certification Exam(s) ]
Trainers [3 Certification Exam(s) ]
Trend [1 Certification Exam(s) ]
TruSecure [1 Certification Exam(s) ]
USMLE [1 Certification Exam(s) ]
VCE [6 Certification Exam(s) ]
Veeam [2 Certification Exam(s) ]
Veritas [33 Certification Exam(s) ]
Vmware [58 Certification Exam(s) ]
Wonderlic [2 Certification Exam(s) ]
Worldatwork [2 Certification Exam(s) ]
XML-Master [3 Certification Exam(s) ]
Zend [6 Certification Exam(s) ]
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