Tuesday, September 6, 2011

Epizyme - 2011 Fierce 15

The Scoop: Many cancer drug developers have put their faith in compounds focused on one misfit gene. However, Epizyme's technology might enable the firm to influence several cancer-related genes with a single small molecule--as well as affect genes that have evaded previous drug regimens. That's part of the promise of the firm's research into targeting certain epigenetic enzymes, which are like conductors whose activities affect entire sections of genes among the proverbial genetic orchestras involved in cancer. Over the past year, the firm has struck lucrative partnerships with several outfits--including major drug players Eisai and GlaxoSmithKline ($GSK)--to help underwrite its research in the hot class of epigenetic enzymes called histone methyltransferases. 

What Makes It Fierce: Epigenetics, which involves causes of altered gene expression other than changes in the DNA code, made the cover of Time magazine last year for its importance in understanding diseases. But Epizyme, which has raised $54 million in two venture rounds, deserves credit for significant progress in transforming epigenetic research into potential drugs. Even more, the company has banked more than $30 million in upfront cash from a sting of partnership deals this year.
Since Robert Gould (pictured) took the top spot at the biotech in early 2010, the business has grown up from a venture-funded research effort to a company with financial ties to Big Pharma outfits and disease groups. He joined the biotech around the same time as Jason Rhodes, a former dealmaker for Alnylam ($ALNY), who's been driving the successful partnership activities as chief business officer.
They've built nicely on the foundation developed with the help of chief scientist Robert Copeland and early CEO Kazumi Shiosaki, the managing director at MPM Capital who's still on the upstart's board of directors. The company also boasts high-profile academic co-founders H. Robert Horvitz, a Nobel Prize-winning biology professor at MIT, and Yi Zhang, a professor of biochemistry at the University of North Carolina Chapel Hill.
Talking to FierceBiotech during this summer's World Epigenetics Summit in Boston, Gould explained there's been intense interest in the company among clinicians even though the firm hasn't begun human testing of its drugs. That's because its compounds are being designed to serve very specific patient populations based on their genetics.
Think of kids with a rare and lethal form of leukemia. The firm is now advancing a small-molecule blocker of an epigenetic enzyme known as DOT1L, which is a culprit in mixed lineage leukemia (MLL), a deadly and small subset of acute leukemias. While the cancer develops in adults, it's notorious for poor prognoses in children. And, in a mouse study published in Cancer Cell in July, researchers showed that Epizyme's small molecule iced MLL cells without having the same killer effects on non-MLL leukemia cells.   
"We had a clinical investigators meeting at the ASH (American Society of Hematology) meeting last December to educate the people who treat these patients [with MLL]," Gould said, "and we had all the world's leading leukemia docs who are treating patients in the same room...it's that specific of a population."    
The Leukemia & Lymphoma Society agreed in June 2011 to provide up to $7.5 million to bankroll Epizyme's drug for MLL through Phase I. Big drugmakers have joined the party, too. Epizyme's research deal with GlaxoSmithKline announced in January 2011 brought the biotech $20 million upfront and gives the London-based drug giant the ability to develop drugs against a certain number of HMT enzyme targets for cancer and other diseases.
Epizyme's pact with Eisai, which was revealed in March, brought a lesser sum at the front end ($6 million). However, the Japanese powerhouse also agreed to fund all R&D costs for drugs involved in the deal through human proof-of-concept studies. That partnership focuses on molecules against the EZH2 enzyme, which plays a role in certain forms of lymphoma and other cancers. 
Epizyme is working toward completing the preclinical work necessary to advance its molecules against EZH2 and DOT1L, its lead projects, into initial clinical trials. Its chiefs wouldn't give a specific date on the start of human trials, but the nature of the IND-enabling studies they're doing now could land the firm's first candidate in the clinic sometime in 2012.
Venture backers: Amgen Ventures, Astellas Venture Management, Bay City Capital, Kleiner Perkins Caufield and Byers and MPM Capital.

Jets coach feels responsible to win Sept. 11 opener

He was asked about his father, Buddy, a tough old bird who fought in the Korean War and is waging yet another war against cancer and still refuses to miss the joy of watching one twin boy coach against his other twin boy Sunday night when the Jets and Cowboys open their seasons at MetLife Stadium, and tears began welling up in Rex Ryan’s eyes.
“Anytime you got cancer again, it’s a huge concern,” Rex Ryan said.
And the health and well-being of his father isn’t all that is weighing on Ryan’s mind as he begins his third Super-Bowl-or-Bust season as head coach of the Jets. The NEW YORK Jets, who will be representing New York on the 10th anniversary of Sept. 11 when America watches them against America’s Team on the grand Sunday night stage.
Ryan searched for the right words to describe how he feels about the responsibilty of coaching the NEW YORK Jets on this night, the significance this game in the shadows of where the Twin Towers once stood brings for him.
“I feel a . . . like a . . . I don’t know, it’s different. . . . Like a responsibility . . . and every week it’s my responsibilty to make sure our team’s prepared, and all that kinda stuff, but I don’t know, it just feels different to me. . . . The significance of it. . . . I think it’s stronger than any game I’ve ever felt,” Ryan said.
“I feel more pressure on this game for whatever reason than any game I’ve ever coached, seems like.”
His twin brother, Rob, on the other sidelines, is chasing the same dream he chases. His 80-year-old father, stiff-arming surgery, will be in the stands to watch his boys. And a city that nothing and no one can keep from standing tall as twin towers both mourning and honoring the memories of the lives that were lost and celebrating our way of life as well.
Rex Ryan has coached in Super Bowl XXX against the Giants, he has coached in the past two AFC Championship games and he has coached aganst his brother. But he has never coached a NEW YORK team on the 10-year anniversary of Sept. 11. That is why he feels more pressure to win this game than any game he has ever coached.
“This whole region, this whole area . . . and I know it’s football, we’re not talking about life or death or anything like that,” Ryan said. “I don’t know, that’s kinda how I’m taking it. It’s my job. My job’s to get this team ready to go, and we will but . . . I can’t explain it, why I feel this way or whatever, but I just do.”
All of us remember the morning of
Sept. 11, 2001. Ryan was the Ravens defensive line coach at the time.
“I was in Baltimore, and Pat Moriarity that — and I was walking by his office, he’s like, ‘Oh my goodness!’ “ Ryan recalled. “And I looked in there, and we were getting ready to practice, so I’m watching it, and then right when I was watching, the other plane hit the second tower. . . . I’m like, ‘Oh my goodness,’ you know? I was thinking about my cousin [Matthew Russo], who was a New York City fireman, and all that . . . so, a lot of thoughts about those times.”
He comes from a tiny place called Ardmore, Okla., but he has never sounded like anything but a New Yorker from the minute he blew into town.
“Everybody deals with their own issues and things,’ Ryan said, “but my job is to coach football and that’s exactly what I’m gonna do.”
He loves coaching the Jets, and never stops loving his team’s chances, in case you haven’t noticed. His players sure have.
“It’s Super Bowl-or-Nothing,” Matt Slauson said. “With us, it is a losing year if we don’t go to the Super Bowl.”
A sense of excitement and anticipation swept across the Jets locker room with the real games finally on the horizon.
“This has been a long time coming . . . having a lockout has made getting here feel like years,” Slauson said. “Brandon Moore? Was out at practice running sprints during practice, and that wasn’t part of his rehab stuff or snything. He was just doing it. Guys are stoked. They want to have the most successful year that we can possibly have.”
Maybe no one appreciates the moment more than Plaxico Burress, three months to the day removed from prison, nearly three years removed from his last regular-season game.
“It’s the start to a long journey,” Burress said.
A journey that maybe only he could see from inside his tiny cell inside the Oneida Correctional Facility.
“I kinda go over in my mind what it’s gonna feel like, but I don’t even know,” Burress said. “When I get out there, whatever happens, if I shed a few tears or whatever that may be, then the world’ll see it. I’m excited, and I don’t want to just start pressing. Just kinda let it come to me.”
Rex-tra special night for Plaxico Burress. For the head coach of the NEW YORK Jets. For all of New York and America.

Giants' Mark Herzlich makes NFL roster not long after beating cancer

To calm collective nerves and pass time during a stressful morning, Mark Herzlich joined three other Giants rookies on Saturday for breakfast at IHOP. Between Herzlich, Tyler Sash, Henry Hynoski and Spencer Paysinger, there was only one drafted player, and all four wondered whether their phone would ring with the news they’d been waived.

Herzlich then spent his afternoon at a local Chili's, sitting by himself while watching Boston College’s season opener. While a student at BC, Herzlich was one of the nation’s top defensive players in 2008. One year later, he was being treated for cancer and faced the possibility of never playing football again.

Herzlich his since recovered from his 2009 diagnosis of Ewing’s sarcoma, a rare bone cancer, in his left leg. He returned to college football last season. More than two years later, he still has the leg and still has a football career.

Both were in doubt at one point.

Herzlich’s NFL career continued after 6 p.m. on Saturday when his phone never rang, signaling that he officially became a member of the Giants — at least for now. He’s one of 10 rookies on the Giants roster, including all four that attended Saturday’s breakfast.

“I want to try to go from being a feel-good story to making an impact on the field,” Herzlich said. “That’s kind of the process, the transition now.”

Because as much as Herzlich has received attention for overcoming cancer, he wants to be viewed as another member of the team. There’s been an ongoing narrative since Herzlich returned to the football about whether he’d ever reach the NFL, and he understands the appeal to the story.

He was invited by the league to the April draft, butwas not selected. Because of the lockout, Herzlich could not sign with the Giants until the week training camp opened. His signing was encouraged by team president John Mara, a Boston College alum, but Mara emphasized that the team viewed Herzlich as a prospect.

Once the ACC defensive player of the year and a surefire first-round pick, Herzlich offered the talent that prompted general manager Jerry Reese to reveal the Giants hoped “to catch lightning in a bottle” by signing Herzlich.

On the first day of practice, Herzlich said reaching an NFL camp provided “a little bit of closure” to his story. The Giants tried Herzlich at each linebacker spot, and Herzlich spent August digesting the playbook. Head coach Tom Coughlin witnessed Herzlich improve “literally week by week.”

In four preseason games, Herzlich forced a fumble, grabbed an interception to prevent a touchdown and recorded a sack. His biggest influence on the team will likely come on special teams, unless injuries ravage the Giants starting linebackers. Herzlich is the only player on the roster besides Kiwanuka to play strongside linebacker during camp.

There’s a sense of relief for Herzlich that he will be viewed as an NFL player and not just a cancer survivor playing football. If he misses a tackle, he knows he’ll be criticized. If he recovers a fumble, he knows he’ll be praised.

“I expect (fans) to be (unhappy) if I make a bad play,” Herzlich said. “I’ll be (unhappy) at myself.”

Sash, whose locker is next to Herzlich’s, knew about Herzlich’s history when he arrived at camp. Sash drew inspiration from his locker mate, knowing he cannot complain on a bad day. But when he thinks about Herzlich now, he doesn’t think about the cancer. Sash has not heard Herzlich discuss the recovery from cancer because “in his mind, he’s over that, too.” And though Herzlich’s history will remain attached to his name, yesterday’s first practice on the 53-man roster started the next chapter in his comeback.

“Your story’s never over because when you talk about the story, that’s actually my life,” Herzlich said. “Maybe the book is getting toward the end of the chapter. But that’s my life. And that’s going to keep on going and lots of changes are going to happen whether it’s related to football or what.”

Thursday, September 1, 2011

Prostate Cancer Awareness Month

This month, the American Cancer Society reminds men of the importance of prostate cancer awareness.

Beginning at age 50, men should have the opportunity to make an informed decision with their health care provider about screening for prostate cancer after receiving information about the uncertainties, risks, and potential benefits associated with screening. African-American men, or men with a family history of prostate cancer, should receive this information at age 45.
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Excluding skin cancer, prostate cancer is the most frequently diagnosed cancer in men and the second leading cause of cancer death in men. Knowing the facts about prostate cancer and early detection is important, particularly this month, Prostate Cancer Awareness Month.

An estimated 240,890 cases of prostate cancer will occur in the U.S. during 2011. The disease accounts for about 29% of newly diagnosed cancers each year in U.S. men. In Nebraska alone, an estimated 1,290 men will hear the words, “you have prostate cancer” and an estimated 280 will die from the disease.

For reasons that remain unclear, incidence rates are significantly higher in African-Americans than in whites. Age is the most important risk factor for prostate cancer and prostate cancer incidence rates increase in men until about age 70 and decline thereafter. The American Cancer Society currently funds 89 research grants relating to prostate cancer. These multi-year grants are for $47 million. Ten of these grants are in the High Plains Division (seven in Texas and two in Missouri), totaling $6.9 million.

Lung Cancer Pill Holds Promise For Those Who Pass Test

From Pfizer, a drugmaker known best for medicines to treat millions, there is now a twice-a-day pill to treat lung cancer that will be prescribed for only a few thousand people each year.

The Food and Drug Administration approved Pfizer's Xalkori to treat patients with a particular form of non-small cell lung cancer, one that is marked by a genetic variation called ALK.

Only people with tumors that test positive for ALK — about 3 to 5 percent of NSCLC patients, or around 6,500 to 11,000 U.S. patients a year — are candidates for the treatment. By comparison, last year more than 45 million prescriptions were dispensed for Lipitor, the cholesterol-fighter that is Pfizer's biggest seller.


The FDA approved the pill in combination with a genetic test to detect the ALK variation to figure out who has the best chance of responding to the medicine.

The new, highly targeted cancer pill won't come cheap at about $9,600 a month. But the benefits for those with the ALK-positive cancers appear to be substantial. Half or more of patients in the studies cited in the FDA approval responded well to treatment with Xalkori. Their tumors shrank or disappeared.

But there are no definitive data so far on whether the drug extends life, though that's expected to be the case. The FDA approved the drug quickly, under a priority review approach reserved for drugs that have special promise. Pfizer has to perform more studies of the drug to confirm the agency's assessment of Xalkori.

Common side effects from Xalkori include vision problems, nausea and diarrhea. More rarely, in less than 2 percent of cases, patients experienced life-threatening inflammation of the lungs.

One high-profile patient who took Xalkori in clinical trials is former Microsoft engineer Andy Hill, a state senator in Washington. Diagnosed with NSCLC in early 2009, he started taking the pill in October of that year. Since Feb. 2010, he's shown no signs of lung cancer. "It's pretty miraculous," he told the Redmond Reporter. "I am doing things I never thought I would ever be able to do again."

For more on Hill's case and how cancer patients can make the best use of the Internet and medical professionals in making treatment decisions, watch the video below of Dr. Jack West, a lung cancer specialist at Seattle's Swedish Medical Center. (Hat tip on video to Sally Church at Icarus Consulting.)

Seizure Drug May Extend Lives of Brain Cancer Patients

Study Shows Benefits of Valproic Acid for Patients With Glioblastomas

As many as half of all people with a common and potentially lethal type of brain cancer known as a glioblastoma will have a seizure at some point during their illness.

Doctors often prescribe a drug to help control these seizures. But until now little was known about which drug, if any, is the best choice.

When added to standard treatment, an older seizure drug, called valproic acid (sold with the brand names of Depakote, Depakene, and Stavzor) may extend the lives of people with this type of tumor by an average of three months, a study shows.

The study is published in Neurology.

"Three months could be a big deal," says Keith L. Black, MD. Black is the chair of the neurosurgery department at Cedars Sinai Medical Center in Los Angeles. He reviewed the study for WebMD.

Glioblastomas are the most common type of brain cancer seen in adults. On average, people live 15 to 18 months after they are diagnosed with this cancer, Black says. 

Standard treatment may include:

    * Surgery to remove as much of the tumor as possible.
    * Radiation therapy to the brain to shrink tumors.
    * The chemotherapy drug temozolomide (TMZ), which slows cancer cell growth. An anti-seizure drug is often added for those individuals who also have seizures.

"First, do no harm," Black explains. The hope was that the drugs would control seizures without dampening the effects of the other treatments.

Certain seizure drugs, called enzyme-inducing anti-epileptic drugs, may interfere with chemotherapy. These drugs include carbamazepine, oxcarbazepine, phenobarbital, and phenytoin.

Until now, no one was thinking that any seizure drug could actually extend the lives of people with brain cancer. "Valproic acid may actually offer an additional benefit besides protection from seizures," Black says.
Impact of Valproic Acid

The study originally set out to compare whether or not chemotherapy provides a survival edge when added to radiation among 573 people with brain cancer. It did.

Of 398 people who were also taking seizure medications, the 97 who took valproic acid lived three months longer than those who took other types of seizure medications. They also lived longer than those who had seizures but were not taking any medication to control them.

There were some side effects seen with valproic acid. These included a drop in the number of white blood cells that could increase a person's risk of getting an infection and a drop in blood platelets that could increase risk of bleeding. The survival benefit was only seen among people who received both radiation and chemotherapy. This suggests there may be a synergy between the chemotherapy drug and the seizure medication.

"It is now very important to go back and try to confirm and understand the mechanism," Black says.

"It is a curious observation," says Cormac O'Donovan, MD. O'Donovan is an associate professor of neurology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. He is also a member of the Brain Tumor Center of Excellence Advisory Board at Wake Forest.

"The science behind it needs to be verified before suggesting this is the drug of choice for people with brain cancer and seizures," he says.

In film and on TV: 'The terror that is cancer'

Hollywood is exploring the topic of cancer.

Mia Wasikowska is a terminally ill cancer patient who meets a guy who crashes funerals. On Sept. 30, Joseph Gordon-Levitt grapples with a potentially deadly form of spinal cancer in 50/50. In next year's Now Is Good, Dakota Fanning plays a girl dying of leukemia and going through her bucket list.
They join TV's Laura Linney, who is battling melanoma on Showtime's The Big C (Mondays, 10:30 p.m. ET/PT), and AMC's Breaking Bad, renewed for its fifth and final season and starring Bryan Cranston as a meth dealer with lung cancer. And on Lifetime, Jennifer Aniston and Demi Moore helped direct Five, interconnected short films about breast cancer airing in October.
The parallels between the projects? Realism, as opposed to overwrought sentimentality, coupled with a little surrealism and hefty dollops of black humor.
"That is what making movies is about, finding the truth and telling it the best way you know how," Fanning says. "I was really moved by the thought of a young girl knowing that there are so many things she will never achieve and truly making the most of what's left of her life."
The mandate for cast and crew: no histrionics or handwringing.
"The biggest challenge is tone. Because the stakes are so high, it's very easy to go into a place of melodrama," says Bryce Dallas Howard, who produced Restless and stars in 50/50. "There's not a higher stake than someone having to face their own death. That's what these movies deal with in different kinds of ways."
A little levity goes a long way. "It helps bring the terror that is cancer home. Let's face it: There's nothing funny about that disease," says Linney's C co-star John Benjamin Hickey.
In 50/50, Gordon-Levitt's best friend uses the disease to pick up girls; Linney's once-estranged husband on The Big C decides to become her personal concierge after he learns of her diagnosis.
"I had cancer, so I know the absurd things that can happen. You always want to be true to the emotional state of the character, and not go into wackiness," says Big C executive producer Jenny Bicks. "We're constantly monitoring ourselves. It's a very fine line."
And a very relatable topic. Nearly everyone has known a person with cancer. More broadly, the concept of life and death is a universal one. "It's something everyone can identify with," says 50/50 director Jonathan Levine.

Steele spikers raising funds to beat cancer

When it takes to the court next Friday, the Steele Lady Knights volleyball team will be counting on its fans to help them defeat a disease that afflicts thousands of women each year.
The Lady Knights will host the New Braunfels Canyon Cougarettes in their third annual Digs for a Cure game at 7 p.m. Sept. 9 in the Steele High gym. Proceeds from the game, which include tickets for door prizes and a silent auction, will go toward fighting breast cancer.
Steele assistant coach Adrienne Kindt, the event organizer, said the goal of this year's fundraising campaign is to raise $7,000 for the Alamo Breast Cancer Foundation, a local non-profit that provides outreach and education programs on breast cancer and free screenings to women who can't afford them.
Last year's Steele-Clark Digs for a Cure game raised $6,300, which topped the $5,500 raised when Steele hosted rival Clemens in 2009.
Kindt, diagnosed with breast cancer a few years ago but now cancer free, said the event has topped its fundraising goal each year because of the tremendous support of the local community and the Lady Knight volleyball players.
“It has really taken off,” Kindt said. “Our girls really get into it. People are always willing to help out no matter what the economy is like. Rarely do we have any of the girls say someone has turned them down.”
Kindt said several area businesses are donating gift cards as part of the door prizes. Other door prizes that will given away include an iPod and Steele T-shirts. Pink T-shirts will be sold at the game.
Jay Pogue, whose daughter plays on the volleyball team, will host a poker tournament at Freiheit Country Store in New Braunfels Sept. 10, the day after the game, with proceeds going to the breast cancer foundation. For more on the poker tourney and how to get involved, contact Kindt at akindt@scuc.txed.net.
On Aug. 31 both of the Schertz Sonic Drive-Ins on FM 78 and at Interstate 35 and FM 3009 allowed Lady Knight volleyball players to sell door prize tickets and donated 10 percent of their dinner proceeds to Digs for a Cure.
During the game, players from both teams will don pink socks and pink hair ribbons, and have temporary tattoos of the pink ribbon, symbol for breast cancer awareness. Game officials will have pink whistles and a pink ball warmup ball signed by Steele players will be presented to an Alamo Breast Cancer Foundation representative.
With thousands of women affected by the disease every year, Kindt said it is important to keep working for a cure.
“You know somebody that has been affected by this,” she said. “Nobody can turn a blind eye to cancer because it is prevalent. What it is we are trying to do is to help bring some awareness and to find that cure. We just (got) to find a cure, so many people are devastated by it.”