Apple might invest "hundreds of millions of dollars" in Twitter, report Evelyn Rusli and Nick Bilton of the New York Times.
The two companies have reportedly held talks in recent months about Apple's making a strategic investment.
The investment could value Twitter at more than $10 billion, higher than the $8.4 billion valuation the company got in a big fund-raising last year.
Apple's efforts to break into social networking (e.g., Ping) have failed. The company has countered this by integrating Twitter and now Facebook into its operating systems.
Obviously, a big investment in Twitter would align Apple with Twitter in a way that might alienate (or disadvantage) Facebook.
Twitter CEO Dick Costolo recently remarked that Twitter has "a truckload of money." A big investment from Apple would presumably increase this to "boatloads."
These are only talks, Bilton and Rusli report. So don't count any chickens just yet.
49ers receiver Randy Moss did a lot of talking on UStream after he decided to return to the NFL and before he found a team.? Since finding a team, he hasn?t done much talking.
On Friday at training camp, he did.
?These guys here love to work, they love to compete and they know just by me signing here it?s just something that me being around a great group of guys [who are] young and enthusiastic makes me feel young, too,? Moss said in comments broadcast on ESPN?s NFL Live.? ?The love that I have for the game of football is gonna always be in me and I just wanna play football and that?s just really being here and Coach Harbaugh and this organization accepting me and bringing me here was just something hopefully I can give something back in return and that?s with my play and my presence out on and off the field.?
Also on Friday, coach Jim Harbaugh continued with the gushing that has emanated from multiple members of the organization throughout the offseason.? ?The funnest part is out on the practice field,? Harbaugh said.? ?I get some joy being around Randy Moss out there.? He?s got a knack for saying the right thing at the right time.? The right joke at the right time.?
The joke ultimately may be on those who are ready to write off Randy?s chances of playing well in 2012.? After his comments were played during NFL Live and Herm Edwards said Moss could catch 10 touchdown passes this year, Adam Schefter and Bill Polian were skeptical, to say the least.
?Ten touchdowns is awfully high for a player who was out of football last year, who had a minimal impact the year before, who basically hasn?t made a contribution ? a meaningful contribution ? since 2009,? Schefter said.? ?There?s a spot for him in the San Francisco 49ers offense.? But we?re not getting the 25-year-old Randy Moss, we?re getting the 35-year-old Randy Moss.?
Polian was more blunt.
?The guy I saw two years ago, played against was not the Randy Moss who set records in New England,? Polian said.? ?I didn?t see any explosion, didn?t see any speed.? [Editor's note:? Darrelle Revis may disagree.]? So, he?ll have to make a believer out of me.? If he?s doing well by Week Eight then he?s back.? Otherwise, I have my doubts.?
It would be easy to agree, given the manner in which Moss disappeared in Tennessee after being essentially fired by two teams in less than a month.? But two factors could prove them wrong.
First, the praise of Moss from his teammates, both for his performance and his attitude, has been universal and unequivocal.? Everyone in San Fran loves the guy, and everyone who has seen him work since joining the 49ers believes he can still get it done.
Second, we?ve seen this movie before from Moss.? After his second year with the Raiders in 2006, the popular view was that Moss was washed up, that he was done, that he couldn?t run.
Rejuvenated by a trade to the Patriots, Moss ran down Jerry Rice?s record for single-season touchdown receptions, propelling the Pats to the first undefeated 16-game season.
When Randy?s head isn?t in it, it doesn?t matter what his body can do.? When Randy is ready to go, his team will get the best of whatever he has.
The point is that we shouldn?t assume anything about Randy?s physical abilities based on what we saw in 2010 because his performance was hampered by the fact that he didn?t care.
He cares now.
?I play when I wanna play.?? It arguably belongs on his tombstone.? For now, it should prompt anyone who thinks based on 2010 that he won?t have it in 2012 to think again.
Jamie P. Merisotis, President & CEO, Lumina Foundation
Keynote Address, National Council of State Directors of Community Colleges, New Orleans, LA
Thank you, and good morning everyone. I?m very pleased to be here. It?s always a special moment to be in New Orleans, and I want to thank the Council?and our hosts, the Louisiana Community and Technical College System?for the opportunity to speak with you today. I also want to congratulate and thank Joe and his colleagues at LCTCS for the wonderful work they?ve done here, particularly in the aftermath of Hurricane Katrina. The area?s community colleges have been instrumental in the rebuilding process, helping countless residents hone the skills they need to move on and move up.
Of course, the resilience and responsiveness of these institutions comes as no surprise to anyone in this room today?and certainly not to me or my colleagues at Lumina Foundation. As everyone in this room knows, Lumina has long appreciated and honored community colleges? immense value. We?ve been partners with this uniquely American?and absolutely vital?sector of higher education for many years. We value the relationship we have built through efforts such as Achieving the Dream, the Developmental Education Initiative, the Aspen Prize for Community College Excellence, Project Win-Win and many others. And I assure you, that relationship is stronger than ever.
In fact, I believe the connection between Lumina and your institutions is sure to become even tighter in coming years. One glance at the agenda for this conference tells me that quite clearly. During these past few days, you?ve covered topics such as performance funding ? developmental education ? issues related to jobs and workforce development. If I didn?t know better, I might think this agenda had been created for a meeting among my own Lumina colleagues back in Indianapolis. In other words, our concerns and our goals aren?t just similar; they are one and the same. And it?s gratifying to see that, in many cases, community colleges and Lumina are working together to address those concerns and reach those goals.
Of course, the overriding goal?the Big Goal that my colleagues and I work toward every day?is one that I know you?re familiar with. We call it Goal 2025. It?s been at the center of Lumina?s radar screen for years, and it?s been on many of yours as well. By 2025, we want 60 percent of Americans to hold high-quality college degrees, certificates or other credentials.
We pursue this goal for a clear and compelling reason: because it must be achieved if our nation and its citizens are to prosper. In this economy?which is becoming more global, more complex and more demanding every day?college-level learning is a precious commodity in the labor market. Economists and labor experts tell us with increasing clarity that postsecondary credentials are vital to any individual who hopes to maintain a middle-class lifestyle. In fact, the evidence these experts cite is voluminous and undeniable. For example:
Roughly two-thirds of jobs now being created require some sort of postsecondary credential.
Even in so-called declining industries, more and more jobs are demanding higher skill levels.
Workers with college credentials are employed at dramatically higher rates than those without postsecondary training.
College-trained workers also earn significantly more in their lifetimes than those who lack such credentials ? and this wage differential is actually widening.
Clearly, the individual benefits of college are huge. And if we want these individual benefits to add up to long-term, sustainable, societal gains, we need to reach the 60 percent threshold. That?s the level that will keep us on par with labor market demands and with the attainment rates in other highly developed countries. Practically, what this means is that we need millions more students to earn degrees and certificates?students of every age ? every color ? every ethnic group and income level ? from every geographic area.
Naturally, pursuing this 60 percent goal serves Lumina?s overall mission, which is to enroll and graduate more students from college?especially low-income students, students of color, first-generation students and adult learners. And again, the connections to your own institutions are strikingly obvious. After all, the student populations we single out as most important are the ones you?ve always served.
I want to point out another connection as well ? one that is relatively recent, very visible and, quite literally, tangible. It?s the recent report from AACC?s 21st Century Commission on the Future of Community Colleges, titled Reclaiming the American Dream. This is yet another indication that Lumina and the nation?s community colleges are very much on the same page. That?s especially remarkable since Lumina didn?t even pay for the report!
I know you?ve had a chance to hear from my friend AACC President Walter Bumphus and discuss the Reclaiming the American Dream agenda over the past two days, but I?d like to reinforce just a couple of the key themes from the report. One is the simple yet powerful framing that the report offers for reimagining the community college. The ?Three Rs??Redesigning the student experience, Reinventing institutional roles, and Resetting the system to create incentives for success?are a wonderful summation of the forward-looking agenda for community colleges.
Among the many excellent recommendations, we are compelled by ideas such as increasing completion rates by 50 percent by 2020, while preserving access, enhancing quality and eradicating attainment gaps. This can be done by building clear pathways to completion, by implementing policies that ensure smooth transfer, and by vigorously supporting student success. We also are enamored of the idea of the community college becoming ?a broker of educational access,? in essence, a hub that connects students to relevant learning from multiple providers through multiple modes of delivery. And of course, no one in this room will be surprised to learn that Lumina strongly agrees with the recommendation that increasing public and private investment in community colleges must be aimed at improving student success and institutional performance. This means revamping student financial aid programs and public funding models so that both actually reward student success and college completion.
Community colleges are ahead of the redesign game in many ways
In the report?s foreword, Walter Bumphus urges community colleges to ?imagine a new future for themselves,? and the report?s introduction calls for ?a dramatic redesign? of your institutions. It?s an exciting prospect and a commendable approach. But, frankly, we at Lumina Foundation take a somewhat broader view. We?re convinced that this ?dramatic redesign? is necessary for all of higher education. What?s more, we feel that community colleges are actually ahead of the game in many ways.
Think about it. Community colleges are the very definition of redesign. Among all of the sectors of higher education, you have most often been the innovators. You?ve always made it your business to be cost-effective. You have a long, strong history of collaboration?with other institutions, with employers, with all types of stakeholders. You were student-centered and flexible long before those terms could accurately be applied in other postsecondary settings. If comprehensive system redesign is needed?and we?re fully convinced that it is?then who better than you to show the way?
Your leadership as state system leaders is especially important at this point in our national dialogue about the future of higher education. Increasingly, we are hearing questions about the value of a college credential, and whether college really is for everyone.
The definition of ?college? includes far more than the four-year degree
My response, of course, is a resounding ?yes,? and I hope yours is as well. But we must be clear that the definition of ?college? includes far more than the four-year degree. It includes all types of post-high school credentials. I also think your leadership is essential in making the case for why college really matters. Clearly college matters for many of the economic reasons that I alluded to earlier in my remarks. The nation?s long-term economic success depends on a 21st century labor force, one with adaptable workers who possess high-level skills and relevant knowledge the types of skills and knowledge that can only be offered in well-designed and rigorous college-level programs.
In addition, I think we need to sharpen our arguments, some of which have been lost in the public debate, about the important social and cultural benefits of increased college attainment. We need to strengthen the understanding among policymakers, employers and the general public that college-educated citizens have proven to be more engaged and more ethical citizens. They?re more likely to vote and volunteer, more likely to appreciate diverse views and perspectives, more apt to demonstrate high levels of moral and ethical decision making.
Really, though, wondering whether college is for everyone is a false premise?as is often the case when dealing in absolutes. The question of whether every person needs college serves only to distract us from the obvious and urgent need to dramatically increase postsecondary attainment overall. It?s not just that credentials matter; it?s that what college gives us individually and collectively matters.
This leads to two other important issues I would urge you to think about, and act upon, in your roles. One is that equity of opportunity matters. Clearly equity is important for moral and ethical reasons. Increasing attainment is important, especially for low-income students, first-generation students, students of color and adult learners. But equity also matters for economic reasons?chiefly because these populations represent the nation?s fastest-growing groups and are most in need of the enhanced skills and knowledge that come from postsecondary education. Therefore, if we fail to ensure equity, we as a society will pay an increasingly higher price for that failure.
The other important issue is to stress that quality matters. Not all credentials yield the same benefits. Clearly, having a college credential is much better than not having one, but postsecondary credentials are most effective when they deliver competencies that are generalizable. In other words, they need to provide recipients with critical thinking, problem solving, analytical and other skills and knowledge. These are the competencies most desired by employers, and they also are the ones that best serve our democratic needs and ideals. Specific content knowledge is important too, of course; but in many real-world, workplace scenarios, it is the generalizable skills that predominate. In any case, given the rapidly evolving nature of work, what is most important is that credentials represent genuine learning that is both generalizable and specific. Real learning: that?s the true definition of quality ? and this type of high-quality educational experience needs to be delivered much more broadly and equitably.
In the very near future, talent is going to be seen as society?s most important resource
The quality discussion also is leading up to what we think could be one of the most game-changing moments in higher education in our lifetimes. Now, more than ever, it?s clear that we need to develop more transparent, recognized pathways to credentials and to better define the credentials that count.? Redesign of what credentials look like, who gets to award them, and what is represented by them is at the core of the nation?s need to better define its talent. Because in the very near future, talent is going to be seen as society?s most important resource, and higher education will be seen as the lever for developing it.
Most community colleges are already ahead in this discussion. Many are deeply involved in noncredit learning delivery that is actually bona fide training leading to tangible workforce outcomes. ? There are also industry-recognized credentials, and the exploding world of open education resources that will enable students to develop knowledge/skills through lower-cost instructional resources. More and more learners expect to be able to use this ?new currency? in meeting their education and employment goals.? And, of course, the new concept of badges?in essence, ?micro-credentials? for discrete knowledge and skills that are awarded through 3rd party assessments?this concept also is garnering significant attention in the community college world.
All of these trends are at work in your institutions today, which shows that community colleges understand the equity-quality imperative. Of course, the best community colleges have always been driven by this dual commitment. What?s more, there seems to be a real hunger out there to ?double down? on this commitment ? an eagerness to seize the opportunity for redesign and self-improvement. We at Lumina have seen this spirit at work for many years and in many community college settings. In fact, we?ve had a front-row seat for several impressive efforts, such as in the ways that many Achieving the Dream colleges have reoriented their campus cultures wholly toward student success.
And we?ve seen it in some work that is just about to begin. We were immensely gratified by the response to an RFP issued for a project called Credit When It?s Due?an effort to increase the number of associate degrees granted in what is commonly called the ?reverse-transfer? process. We received proposals from a total of 32 different entities, an impressive response. Nearly all of these represent statewide partnerships that include hundreds of community colleges, plus public university and independent college partners.
What all of these examples demonstrate is that community colleges are committed to improvement. You?re eager to retool, to build the type of higher-ed system that serves all students and our nation ? the kind that is very much needed if we hope to reach Goal 2025.
We all know what kind of system that needs to be: a student-centered system ? one that meets students where they are and gives them the support they need to succeed ? One that ensures quality by fostering genuine learning. ? One that truly prepares students for work?and for life?in an increasingly global society. ? One that is flexible, accessible, accountable and committed to quality. And it?s critically important that the system be designed to serve today?s students?the ever-growing number of low-income, first-generation, minority and adult students who constitute the ?real world? on campuses and in classrooms these days.
Of course, community colleges are just one part of that system, but they are a formative and fundamental part ? in many respects the point of the spear. The fact is, there is simply no way for the nation to return to a position of global leadership in degree attainment, no way for us to reach that 60 percent target, unless community colleges lead the way.
Notice the word I used there: lead. The drive to boost college attainment offers you and your institutions a singular and historic opportunity for leadership. Because of your expertise in creating workforce-relevant programs, because of your long experience in serving adult and minority students, because of the decades you have spent perfecting innovative and cost-effective ways to deliver high-quality education?because of all these things and more, you can show the way to reshaping American higher education in a way that benefits us all.
Let me be clear, though: We at Lumina recognize the challenges you face in seizing this leadership role. We understand the pressures that community colleges and systems are under: You all must serve multiple constituencies: your students, your individual states, and the various employers in the areas you serve. You all face increasingly loud calls for accountability and relevance. Your enrollments are increasing rapidly, and these growing waves of students are often those who face the most daunting barriers to success. And in most cases, you?re being asked to handle all of these demands even while your funding is being cut.
I?ve noted with admiration Joe May?s recenttestimony before the U.S. House Subcommittee on Higher Education and Workforce Training. He pointed out that, over the past 5? years, enrollment in LCTCS has grown by 55 percent while state support for the system has declined by 37 percent. Clearly, those starkly opposing trends reflect a serious challenge that no one can ignore.
And yet, as I hope I?ve made clear this morning, opportunity exists as well for the nation?s community colleges. The institutions that are focused and forward-looking ? those that can act decisively on the innovative spirit that has always been a hallmark of community colleges ? those that can truly put student success at the top of the agenda ? these are the institutions that will not merely survive; they will thrive. More important, they will help this nation meet its most urgent and compelling need.
And so, let me urge you to embrace your leadership role in helping reach Goal 2025. It is a challenge for which you are well suited ? and one in which you can always count on Lumina for support and partnership.
The Bills haven?t been to the postseason since Frank Wycheck threw the ball to Kevin Dyson on a late-game kickoff return, and Dyson then ran untouched to the end zone to polish off the Music City Miracle.
Buffalo?s pro football team has flirted with a playoff berth several times since then, but they haven?t been able to finish the job.? As the 2012 season approaches, the talk has become less about hope and more about expectation, week by week and for the full season.
?One thing Coach [Chan] Gailey has done is taken us from a team that hopes to win and hopes to have the ball bounce our way to a team that expects to win when we take the field,? safety George Wilson told Tim Graham of the Buffalo News.
G.M. Buddy Nix says that, when he returned to the Bills as a scout in 2009, he sensed that the organization was in a funk.? ?We needed a culture change,? Nix said.
?Sometimes you have to change a bunch of people, and that?s not an easy thing,? Nix explained.? ?If you get people who are complacent, whether they?re players or anywhere in the building, you try to get by that.? We went a year with most folks [at One Bills Drive].? But if they couldn?t make the change, then you make a change.?
Part of the change has been to get the right kind of players.? ?I don?t think you do that unless you emphasize all areas of life, not just football,? Gailey said.? ?We have guys that believe in doing things the right way.? It?s proven out.? We have very few incidents on our football team because I believe we?ve got the right kind of men.?
Wilson says that attitude has resulted in a disappearance of bickering among players.? ?We don?t have the locker-room-lawyer stuff that divides a team,? Wilson said. ?We don?t allow the friendly fire.? We try to protect each other, come to each other?s aid. But we hold each other accountable.? We don?t let anybody cut corners.
?We have good people in the locker room.? They want guys they can trust even when they?re not looking.? That changed the culture with the kind of men we have.?
None of it will matter if quarterback Ryan Fitzpatrick doesn?t improve significantly under quarterbacks coach David Lee, or if the new Dave Wannstedt defense will be sufficiently disruptive, with the addition of Mario Williams and Mark Anderson.
But at least there?s reason for hope.? No, there?s reason for expectation.
John Theurer Cancer Center researchers shed light on new multiple myeloma therapyPublic release date: 25-Jul-2012 [ | E-mail | Share ]
Contact: Amy Leahing aleahing@p4strategy.com 305-458-0599 John Theurer Cancer Center
Multi-center clinical trial results demonstrate safety and efficacy of carfilzomib for newly diagnosed and relapsed patients
HACKENSACK, N.J. (July 25, 2012) Researchers from John Theurer Cancer Center at HackensackUMC, one of the nation's 50 best hospitals for cancer, played leading roles in three separate multi-center studies with the new proteasome inhibitor carfilzomib published in Blood, a major peer-reviewed scientific journal.
Carfilzomib is a novel, highly selective proteasome inhibitor, a type of medication that blocks the actions of certain proteins (proteasomes) that cancer cells need to survive and multiply. Carfilzomib is also known by its branded name Kyprolis.
On July 20th the U.S. Food and Drug Administration (FDA) approved Kyprolis (carfilzomib) as a new treatment for advanced multiple myeloma. The treatment was fast-tracked due to the unmet need in multiple myeloma.
The most recent Blood study, published online today, includes results from the open-label, single arm phase IIb 003-A1 study of single-agent carfilzomib for patients with relapsed and refractory multiple myeloma. Carfilzomib's New Drug Application (NDA) is based primarily on this study. This research, along with the two other Blood studies, may change the way multiple myeloma is managed for newly diagnosed and relapsed/refractory patients.
Phase IIb Clinical Trial Published in Blood
David S. Siegel, M.D., Ph.D., Chief, Multiple Myeloma was the lead investigator of this pivotal
multi-center, phase IIb study involving 30 cancer centers in the United States and Canada. The trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.
"We found that carfilzomib produced clinically significant responses with an acceptable safety profile in heavily pretreated patients with relapsed and refractory multiple myeloma," said Dr. Siegel. "Given the limited number of treatment options available to patients with advanced-stage multiple myeloma and the diminished prospects for retreatment once an agent has been utilized, we believe there is a significant need in this patient population."
Two hundred and sixty-six patients received single agent carfilzomib twice weekly for 3 out of 4 weeks. The study's primary endpoint was overall response rate (ORR; ?partial response) and secondary endpoints included clinical benefit response rate (?minimal response), duration of response (DOR), time to progression, progression-free survival, overall survival (OS), and safety.
ORR was 23.7 percent with median DOR of 7.8 months. Median OS was 15.6 months. Adverse events (AEs) were manageable without cumulative toxicities. The researchers concluded that durable responses and an acceptable tolerability profile in this heavily-pretreated population demonstrate the potential of carfilzomib to offer meaningful clinical benefit.
Phase 1/2 Results for Frontline Therapy for Newly Diagnosed Multiple Myeloma Patients
David H. Vesole, M.D., Ph.D., F.A.C.P., Co-Chief and Director of Research served as co-author of a study published on June 4th in Blood, which involved researchers from six leading cancer centers. The multi-center, open-label phase 1/2 study looked at carfilzomib in combination with lenalidomide and low-dose dexamethasone (CRd) as a frontline treatment for multiple myeloma.
"Triple-agent regimens with bortezomib, lenalidomide, and/or thalidomide are currently the preferred frontline strategy for newly diagnosed multiple myeloma. However, maintaining dose levels over time can be limited by the treatments' emerging toxicities," said Dr. Vesole. "This study demonstrated that the combination of carfilzomib, lenalidomide and dexamethasone is well tolerated and highly active for these patients."
The researchers enrolled 53 patients with newly-diagnosed multiple myeloma who had symptomatic disease. Patients received CRd induction therapy in 28-day cycles for up to eight cycles or until disease progression or unacceptable toxicity. After eight cycles, patients received maintenance CRd for up to 24 cycles and then moved to a single-agent lenalidomide.
During phase 1, the primary endpoints were safety and determination of the maximum tolerated dose of carfilzomib within the context of CRd combination therapy. Carfilzomib doses were escalated, while lenalidomide and dexamethasone were given at standard low-dose induction levels. Once the maximum tolerated dose of carfilzomib was reached, the researchers began Phase II with a primary endpoint of near complete response (nCR). Secondary endpoints were overall response rate, time on study, duration of response, progression-free survival (PFS), time to progression, overall survival and overall treatment toxicity.
Study results indicated that patients experienced a rapid and good initial response to CRd, and their responses improved as the trial continued. Of the 49 patients who completed four treatment cycles, 67 percent achieved at least nCR, with 45 percent in stringent complete response (sCR), defined as no detectable tumor cells or myeloma protein in the blood or bone marrow. Of the 36 patients who completed eight or more treatment cycles, 78 percent achieved nCR with 61 percent in sCR. Overall, 62 percent of trial participants achieved at least nCR, with 42 percent achieving sCR. The investigators also found PFS rates were 97 percent at 12 months and 92 percent at 24 months. All patients who achieved sCR continued to respond to therapy for a median of nine months, demonstrating the durability of responses to this regimen. Importantly, these periods of extended treatment were well tolerated, including low rates of peripheral neuropathy, a treatment-limiting side effect of bortezomib, the first-generation proteasome inhibitor.
Bortezomib is currently FDA approved to treat advanced multiple myeloma, however, it has been shown to cause peripheral neuropathy in approximately 38 percent of treated patients with subcutaneous administration.
Phase II 004 Clinical Trial Results for Advanced Myeloma
Dr. Siegel and Dr. Vesole served as co-investigators on an 18-center, phase II open-label efficacy and safety clinical trial, also known as 004, of carfilzomib in combination with Bortezomib, another proteasome inhibitor. The study was published in the June 14th issue of Blood.
"We saw significant responses in patients considered more difficult to treat, including those with more advanced disease and poor prognoses," said Dr. Siegel, the senior author of the study. "Our results support the potential use of carfilzomib in this patient population."
The researchers enrolled 129 patients with multiple myeloma who had relapsed following one to three previous courses of treatment. Patients treated with bortezomib were excluded, as it is in the same drug class as carfilzomib and its use might make the effect of carfilzomib more difficult to determine. The study's primary endpoint was overall response rate. Researchers also measured patients' responses at various intervals as well as time to disease progression, and recorded reactions (adverse events) to treatment.
The most common adverse events in the study were fatigue (62 percent) and nausea (48.8 percent), while 17.1 percent of patients developed peripheral neuropathy, mostly Grades 1 and 2. Peripheral neuropathy, damage to nerves that fan out across the body from the brain and spinal cord, causes pain and other symptoms; lower grades have less severe symptoms. Peripheral neuropathy has been reported in 37-70 percent of myeloma patients receiving other commonly used drug therapies.
"Our myeloma team is leading the way in innovative research that makes promising therapies available to our patients, while also continually testing new ways to improve patients' quality of life," said Andrew L. Pecora, M.D., F.A.C.P., C.P.E., Chief Innovations Officer and Professor and Vice President of Cancer Services, John Theurer Cancer Center.
###
About John Theurer Cancer Center at Hackensack University Medical Center
John Theurer Cancer Center at Hackensack University Medical Center is among the nation's top 50 U.S. News and World Report Best Hospitals for cancer the highest-ranked cancer center in New Jersey with this designation. It is New Jersey's largest and most comprehensive cancer center dedicated to the diagnosis, treatment, management, research, screenings, preventive care, as well as survivorship of patients with all types of cancer.
Each year, more people in the New Jersey/New York metropolitan area turn to the John Theurer Cancer Center for cancer care than to any other facility in New Jersey. The 14 specialized divisions feature a team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. John Theurer Cancer Center provides comprehensive multidisciplinary care, state of the art technology, access to clinical trials, compassionate care and medical expertiseall under one roof. For more information please visit jtcancercenter.org.
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John Theurer Cancer Center researchers shed light on new multiple myeloma therapyPublic release date: 25-Jul-2012 [ | E-mail | Share ]
Contact: Amy Leahing aleahing@p4strategy.com 305-458-0599 John Theurer Cancer Center
Multi-center clinical trial results demonstrate safety and efficacy of carfilzomib for newly diagnosed and relapsed patients
HACKENSACK, N.J. (July 25, 2012) Researchers from John Theurer Cancer Center at HackensackUMC, one of the nation's 50 best hospitals for cancer, played leading roles in three separate multi-center studies with the new proteasome inhibitor carfilzomib published in Blood, a major peer-reviewed scientific journal.
Carfilzomib is a novel, highly selective proteasome inhibitor, a type of medication that blocks the actions of certain proteins (proteasomes) that cancer cells need to survive and multiply. Carfilzomib is also known by its branded name Kyprolis.
On July 20th the U.S. Food and Drug Administration (FDA) approved Kyprolis (carfilzomib) as a new treatment for advanced multiple myeloma. The treatment was fast-tracked due to the unmet need in multiple myeloma.
The most recent Blood study, published online today, includes results from the open-label, single arm phase IIb 003-A1 study of single-agent carfilzomib for patients with relapsed and refractory multiple myeloma. Carfilzomib's New Drug Application (NDA) is based primarily on this study. This research, along with the two other Blood studies, may change the way multiple myeloma is managed for newly diagnosed and relapsed/refractory patients.
Phase IIb Clinical Trial Published in Blood
David S. Siegel, M.D., Ph.D., Chief, Multiple Myeloma was the lead investigator of this pivotal
multi-center, phase IIb study involving 30 cancer centers in the United States and Canada. The trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.
"We found that carfilzomib produced clinically significant responses with an acceptable safety profile in heavily pretreated patients with relapsed and refractory multiple myeloma," said Dr. Siegel. "Given the limited number of treatment options available to patients with advanced-stage multiple myeloma and the diminished prospects for retreatment once an agent has been utilized, we believe there is a significant need in this patient population."
Two hundred and sixty-six patients received single agent carfilzomib twice weekly for 3 out of 4 weeks. The study's primary endpoint was overall response rate (ORR; ?partial response) and secondary endpoints included clinical benefit response rate (?minimal response), duration of response (DOR), time to progression, progression-free survival, overall survival (OS), and safety.
ORR was 23.7 percent with median DOR of 7.8 months. Median OS was 15.6 months. Adverse events (AEs) were manageable without cumulative toxicities. The researchers concluded that durable responses and an acceptable tolerability profile in this heavily-pretreated population demonstrate the potential of carfilzomib to offer meaningful clinical benefit.
Phase 1/2 Results for Frontline Therapy for Newly Diagnosed Multiple Myeloma Patients
David H. Vesole, M.D., Ph.D., F.A.C.P., Co-Chief and Director of Research served as co-author of a study published on June 4th in Blood, which involved researchers from six leading cancer centers. The multi-center, open-label phase 1/2 study looked at carfilzomib in combination with lenalidomide and low-dose dexamethasone (CRd) as a frontline treatment for multiple myeloma.
"Triple-agent regimens with bortezomib, lenalidomide, and/or thalidomide are currently the preferred frontline strategy for newly diagnosed multiple myeloma. However, maintaining dose levels over time can be limited by the treatments' emerging toxicities," said Dr. Vesole. "This study demonstrated that the combination of carfilzomib, lenalidomide and dexamethasone is well tolerated and highly active for these patients."
The researchers enrolled 53 patients with newly-diagnosed multiple myeloma who had symptomatic disease. Patients received CRd induction therapy in 28-day cycles for up to eight cycles or until disease progression or unacceptable toxicity. After eight cycles, patients received maintenance CRd for up to 24 cycles and then moved to a single-agent lenalidomide.
During phase 1, the primary endpoints were safety and determination of the maximum tolerated dose of carfilzomib within the context of CRd combination therapy. Carfilzomib doses were escalated, while lenalidomide and dexamethasone were given at standard low-dose induction levels. Once the maximum tolerated dose of carfilzomib was reached, the researchers began Phase II with a primary endpoint of near complete response (nCR). Secondary endpoints were overall response rate, time on study, duration of response, progression-free survival (PFS), time to progression, overall survival and overall treatment toxicity.
Study results indicated that patients experienced a rapid and good initial response to CRd, and their responses improved as the trial continued. Of the 49 patients who completed four treatment cycles, 67 percent achieved at least nCR, with 45 percent in stringent complete response (sCR), defined as no detectable tumor cells or myeloma protein in the blood or bone marrow. Of the 36 patients who completed eight or more treatment cycles, 78 percent achieved nCR with 61 percent in sCR. Overall, 62 percent of trial participants achieved at least nCR, with 42 percent achieving sCR. The investigators also found PFS rates were 97 percent at 12 months and 92 percent at 24 months. All patients who achieved sCR continued to respond to therapy for a median of nine months, demonstrating the durability of responses to this regimen. Importantly, these periods of extended treatment were well tolerated, including low rates of peripheral neuropathy, a treatment-limiting side effect of bortezomib, the first-generation proteasome inhibitor.
Bortezomib is currently FDA approved to treat advanced multiple myeloma, however, it has been shown to cause peripheral neuropathy in approximately 38 percent of treated patients with subcutaneous administration.
Phase II 004 Clinical Trial Results for Advanced Myeloma
Dr. Siegel and Dr. Vesole served as co-investigators on an 18-center, phase II open-label efficacy and safety clinical trial, also known as 004, of carfilzomib in combination with Bortezomib, another proteasome inhibitor. The study was published in the June 14th issue of Blood.
"We saw significant responses in patients considered more difficult to treat, including those with more advanced disease and poor prognoses," said Dr. Siegel, the senior author of the study. "Our results support the potential use of carfilzomib in this patient population."
The researchers enrolled 129 patients with multiple myeloma who had relapsed following one to three previous courses of treatment. Patients treated with bortezomib were excluded, as it is in the same drug class as carfilzomib and its use might make the effect of carfilzomib more difficult to determine. The study's primary endpoint was overall response rate. Researchers also measured patients' responses at various intervals as well as time to disease progression, and recorded reactions (adverse events) to treatment.
The most common adverse events in the study were fatigue (62 percent) and nausea (48.8 percent), while 17.1 percent of patients developed peripheral neuropathy, mostly Grades 1 and 2. Peripheral neuropathy, damage to nerves that fan out across the body from the brain and spinal cord, causes pain and other symptoms; lower grades have less severe symptoms. Peripheral neuropathy has been reported in 37-70 percent of myeloma patients receiving other commonly used drug therapies.
"Our myeloma team is leading the way in innovative research that makes promising therapies available to our patients, while also continually testing new ways to improve patients' quality of life," said Andrew L. Pecora, M.D., F.A.C.P., C.P.E., Chief Innovations Officer and Professor and Vice President of Cancer Services, John Theurer Cancer Center.
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About John Theurer Cancer Center at Hackensack University Medical Center
John Theurer Cancer Center at Hackensack University Medical Center is among the nation's top 50 U.S. News and World Report Best Hospitals for cancer the highest-ranked cancer center in New Jersey with this designation. It is New Jersey's largest and most comprehensive cancer center dedicated to the diagnosis, treatment, management, research, screenings, preventive care, as well as survivorship of patients with all types of cancer.
Each year, more people in the New Jersey/New York metropolitan area turn to the John Theurer Cancer Center for cancer care than to any other facility in New Jersey. The 14 specialized divisions feature a team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. John Theurer Cancer Center provides comprehensive multidisciplinary care, state of the art technology, access to clinical trials, compassionate care and medical expertiseall under one roof. For more information please visit jtcancercenter.org.
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After submitting to a second polygraph test, the mother of one of two missing Iowa cousins said Monday the results should prove that she had nothing to do with their disappearance and allow investigators to focus their attention elsewhere.
Misty Cook-Morrissey said a state agent asked during Monday's polygraph whether she had anything to do with the abduction of her daughter, 10-year-old Lyric Cook-Morrissey, and niece, 8-year-old Elizabeth Collins. She said she was asked whether she knows where they are and if she could take investigators to them, adding she answered "no" to all those questions.
"It went well," she said in a phone interview afterward. "They can rule me out of their book and move on to something else."
The girls have been missing since they went for a bike ride July 13 in Evansdale, a town of 4,700 people in northeast Iowa, where their bikes and a purse were found near a lake. An extensive investigation involving local, state and federal agents has failed to find them.
Investigators say they have reason to believe the girls were abducted and remain alive, but they will not elaborate. They ruled out the possibility that the girls died in Meyers Lake after an FBI team used sonar equipment to search the bottom.
At a press conference Monday, chief deputy Captain Rick Abben said evidence indicating the girls are alive was sent to the state crime lab.
FBI spokeswoman Sandy Breault said Monday that investigators want to interview a person who was paddleboating on the lake around the time the girls disappeared. She said that person, who has not voluntarily come forward, could help investigators learn what happened to the girls but was not considered a suspect.
Breault declined comment on Cook-Morrissey's polygraph test.
Investigators have been delving into the background of Cook-Morrissey and her estranged husband, Dan Morrissey, who have both spent time in prison on methamphetamine-related charges. The two faced additional scrutiny last week when they announced they had been advised by an attorney to stop cooperating with investigators. A judge last week ordered Morrissey to be monitored by state parole agents while he awaits trial on charges of making and dealing meth that could lock him up for decades.
The couple's temporary lack of cooperation with police caused friction with Heather and Drew Collins, Elizabeth's parents. Police had also repeatedly called it a distraction in recent days and called for total cooperation.
Cook-Morrissey said she'd declined to cooperate after she was treated harshly during a polygraph test last week in which she was accused of taking the girls, but agreed Monday after investigators promised to take a different approach and allow a relative to be nearby.
Cook-Morrissey, 34, said she was told she passed Monday's test after last week's came back inconclusive. She said the examinations were stressful for her since she has anxiety disorder, which made it hard to stay calm and may have contributed to the earlier inconclusive result.
Cook-Morrissey said Monday's test and a meeting afterward with investigators over doughnuts went a long way toward easing tensions between her family and the police.
"You could say we made peace today," she said. "We looked at some pictures. We talked. It went really well. I think they are trying a lot harder than I was feeling the last few days."
Cook-Morrissey said investigators did not share any new information with her about why they believe the girls are alive, but told her they were confident the case would be resolved.
She said she also met Monday morning with the Collins' family. She called tension within the family as "very normal" in a case where relatives have fear and stress but no answers about what happened.
A spokesman for the Collins' family, Craig Ceilly, emphasized that Heather and Drew Collins have been "cooperating 300 percent from day one" with investigators as they live through what he called their worst nightmare.
"Anything they can do to help they will do and they are doing willingly. I cannot speak for Dan and Misty," he said. "I don't know what they are doing. I don't have a clue, nor do Heather and Drew. They don't want to know. All of a sudden when the media started looking at their past, it took a turn for the worse."
NBC's Isolde Raftery contributed to this report.
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Thanks to those of you who provided me with some feedback on the podcast. ?Yes, I know the quality has been questionable at times, but this episode should hopefully be a little more to your liking.
I am very excited to introduce this episode to you. ?Nancy, a native from Oxford, talks about how she scored band 9 in Speaking, Listening and Writing! ?Click here to listen to the entire interview!
Last week, a student suggested I post ?key points? for each podcast episode to help listeners decide whether to tune in or not. ?So in my talk with Nancy, we discuss:
-difficulties native speakers have when taking the IELTS
-what she did to prepare for her exam
-what she recommends students do to prepare properly
-how she responded during the speaking portion of the exam
As always, please provide me with feedback and consider leaving me a generous 5 star rating on iTunes.
To subscribe to IELTSCast and have these interviews automatically sync to your mobile device through iTunes,?click here. ?If you do not use iTunes, you can access all former episodes?here.
Have you scored band 7 or higher? ?Consider sharing your IELTS related study and testing tips with the world through a recorded interview!?
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Public release date: 25-Jul-2012
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