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PAGE 2B HERITAGE FLORIDA JEWISH NEWS, JUNE 20, 2014 Groundbreaking insulin pill nearing market By Abigail Klein Leichman nobody had found a way to orally deliver large-molecule polypeptides such as insulin and vaccines. Israel is a major center for diabetes research, and in fact the technology underly- ing Oramed is based on 25 years of research at Hadassah University Medical Center in Jerusalem by scientists in- cluding Kidron's mother, Dr. Miriam Kidron.. "After the breakthrough, we sat and talked about how it could help millions, but to do that you need to establish a company and get it financed," Kidron relates. "I'm a lawyer with an MBA, so I started the company and raised the money nearly eight years ago." The . elder Kidron is chief medical and technology officer of the publicly owned Oramed, and Hadassah is a stakeholder. "When they initiated this project almost 30 years ago at Hadassah, trying to get insulin delivered orally looked almost impossible," says Kidron. "To- day it's just a matter of time till it's on the market." Insulin capsule can slow the progression of diabetes Kidron explains that Oramed's management de- cided to focus solely on in- sulin not only because of the founding scientists' expertise in diabetes research, but also because insulin levels are quite easy to measure in the blood. And from a business stand- point, diabetes represents a giant market. Some $471 billion was spent worldwide last year to treat diabetes, and the International Diabetes Foundation estimates that by 2030, some 552 million people in the world will be diagnosed with the disease. Most importantly, says Kidron, Oramed's insulin cap- sule could slow the progression of Type 2 diabetes, which has three classic phases. The first phase can be addressed through diet and exercise, while the next phase requires oral medications that boost the body's own insulin production. In the third phase, when the insulin-producing pancreas cannot continue pro- ducing the hormone, a patient becomes insulin-dependent. "We wanted to do more than just replace injections --we wanted to provide an alterna- tive oral medication as an ear- lier treatment that can extend the second phase and prevent patients from becoming insu- lin dependent," says Kidron. "That's the revolution." By offering a better solu- tion in the second phase of the disease, Oramed could assure that people with Type 2 diabetes avoid further com- plications of tle disease, while benefiting from a less painful, more convenient and more affordable treatrflent. Other diabetes reeds in the pipeline Because Type 2 diabetes often results from excess body weight, Oramed is also developing an oral capsule containing the hormone ex- enatide, which helps balance blood sugar levels and controls "This is a very potent drug in the world of diabetes. We are now doing trials at Hadassah, and probably toward the end of the first quarter of 2013 we should have results," says Kidron. "If it's successful, we will then file for FDA approval." Oramed has a third product in the pipeline that combines oral insulin and oral exenatide. Preliminary results of this therapy were presented at the meeting of the American Diabetes Association last June, demonstrating a greater posi- tive effect when the two prod- appetite. Exenatide can be ucts were given in tandem. given by injection but it tends .... We saw that one plus one to make people nauseous. The equals three when people take oral preparation would reduce these together," says Kidron, that side effect and open it up "and giving them together is to a much larger market, better than giving them sepa- For 100 years, scientists searched for a way to deliver insulin orally instead of by injec- tion. Now an Israeli team claims it's found'the solution. Phase 2 clinical trials are coming. Jerusalem's Oramed Phar- maceuticals is one step closer to putting a groundbreaking oral insulin capsule on the market for people with Type 2 diabetes. The company is about to begin Phase 2 clinical trials on 147 people at about a dozen medical centers in the United States. CEO Nadav Kidron tells ISRAEL21c that the com- pany's flagship product could revolutionize the treatment of diabetes, which now affects more than 371 million people worldwide and is the seventh leading cause of death in the United States. Most cases are Type 2, where the body does not use the hormone insulin ef- fectively to metabolize sugars. The current method of self- injecting insulin is unpleasant and also carries the constant risk of infection. A capsule taken by mouth would be more convenient and also more natural, as it would mimic insulin's normal route in the body. But until now rately. So it's another break- through not just in delivery but in combining these products." Human trials have yet to begin but results in animal models are promising. Though the company em- ploys just 11 people, Oramed is backed by a scientific advisory board that includes top dia- betes researchers. It includes, among others, Nobel Prize laureate Dr. Avram Hershko; Dr. Michael Berelowitz, former senior vice president of Pfizer; Gerald Ostrov, former CEO of Bausch & Lomb and former senior executive of Johnson & Johnson; and Prof. Derek LeRoith, chief of endocrinol- ogy, diabetes and bone disease at the Mount Sinai School of Medicine in New York. Diamond minds: Baseball bonds generations of Shapiros By Hillel Kuttler 1950s, when Ron's immigrant father, also named Mark, took his young son by train from their home in Philadelphia to a World Series game at Yankee Stadim'n in New York ,o Ron and Mark shapiro have combined for 62 years of baseball-related employment that began when the Orioles' then-owner, Jerry Hoffberger, asked Ron, a lawyer friend, in 1975 to assist Brooks Robinson with financial problems the team's All-Star third baseman was experiencing. It launched Ron Shapiro into a lucrative career as an agent representing athletes in contract negotiations. The work appealed to Mark Shapiro, too, but he blazed a different path to his baseball life. In 1991, he took an entry- level job with the Indians that included chauffeuring prospective free agents such as pitchers Sid Fernandez and David Wells from the airport. From there he would serve as director of player development, assistant general manager and general manager before being promoted to president four years ago. Their jobs, at least occasion- ally would have pitted Shapiro =the agent against Shapiro the executive, :'Instead, they recused themselves from face- to-face involvement. "When it came to doing contracts, he delegated and I delegated," Mark Shapiro said. "It just seemed like the right way, the honest way, to handle it." Ron Shapiro said he's heard plenty of kind words around baseballaboutMark's integrity. "What does a father feel oth- er than unbelievable pride?" he said. "I look at Caden looking at his father, and the relationship continues." Mark and Ron Shapiro see each other five or six times a year--they had been together a month earlier at the New Jerse bat mitzvah of Mark Shapiro's niece--but speak by telephone several times aweek. "Nothing happens of major Shapfi'o not far from here sur- importance where we don't veying the acreage thatwould talk to each other," said Ron becomeastadiumandcomplex Shaliro, 71. for the minor-league Aberdeen "It makes me happy to see Ironbirds and youth leagues kids playand parents and kids to draw the next generation interacfingaround baseball, " of players: "' said Mark Shapiro, 47. At the Ripken' facility, Mark It was Mark Shapiro who Shapiro called over former co-founded the Spidersza'---a major-league first baseman name the Indians had usedin Sean Casey to' address the the late 19th century--two Spiders. Casey, coaching his years ago to imbue youth son Jake's Pittsburgh club, baseball with values that he stood beside his own father, thought were missing. Jim, who had enlisted Ron In youth baseball, "the Shapiro as his son's first agent overarching opportunity is upon his being drafted by the character development," Mark Indians in 1997. Shapiro said, sitting with his Jake and Caden's teams father in the shade following would square off that after- Caden's game. "Character is noon. Close friends Casey and howdoyourespOndtoadversity  Mark Shapiro would be in the [and] setbacks? Being a great coaching boxes. teammate, showing respect-- "Take it easy on us," Casey that's at the core of what this told the Spiders. experience provides for us as Coaching theSpidershelped coaches and as fathers." Mark Shapiro overcome the They _have the perfect role temptation to attend the model in Ripken. The Orioles Indians-Orioles series. Sowas formerstarinfielder, baseball's visiting with his father and ironman, had stood with Ron stepmother, Cathi, at their How breast cancer 'expresses itself' offcertain parts of a cell's DNA code or blueprint in healthy breast tissue cells, may also play a critical role in the de- velopment of breast cancer. Their research, published in PLOS ONE, focused on one . particular gene -- TRIM29 -- selected from a pool of 100 genes with regulatory" patterns specific to normal breast tissue, to prove the link between breast-specific genes and the pathology of cancer. "We found that normal tissue affects the cancer that grows in that organ -- in other words, the specific pattern of gene regulation in the normal breast affects breast cancer, the characteristics of the dis- ease, and its clinical behavior," said Dr. Avraham, a biologist and a researche" in the lab. "We hope that this study will lead to a better understanding of the cancer predisposition of mammary tissues and point to new targets for cancer intervention." Searching for the right gene In the study, normal tissue samples taken from con- ventional breast reduction surgeries were examined in a laboratory. The researchers isolated the milk ducts and purified the breast-tissue cells to create a cell culture, which was then tested for different gene regulation profiles. Whileall cell types share the same genetic code (DNA), certain genes are specifically "expressed" or "silenced" in each cell type. Consequently, the unique gene expression. patterns in every tissue dic- tate its structure and func- tion. Various "gatekeeper" mechanisms either allow or block gene expression in our cells. One such mechanism is "DNA methylation," which shuts off or silences parts of the genetic code to form a specific pattern that identifies each tissue type. The researchers compared the DNA methylation profiles of thousands of genes in breast, colon, lung, and endometrial tissues, selecting one gene, TRIM29, for further analysis. was silenced in normal cells and over-expressed in tumors. This emphasizes the link between tissue-specific gene regulation and the develop- ment of cancer." Silencing the cancer "Tissue-specific genes often take part in carcinogenesis. A well known example is es- trogen, which is involved in the normal differentiation of the breast and also in breast cancer development," said They found that the TRIM29 Dr. Evron, a senior oncologist gene bore a unique DNA regu- lation in normal and cancer- ous breast tissues as opposed to other organ tissues. "In breast tissue we found that this gene was expressed in normal cells and silenced in the cancer cells," said Dr. Avraham. "In contrast, in other bodily tissues, the gene and a researcher in the lab. "Thus, the estrogen receptor over-expresses in nearly 70% of breastcancers. It's the targetof very effective anti breast can- cer therapy. In this study we identify more genes that have specific regulation in normal breast tissue as comparedwith other organ tissues." suburban Baltimore farm. Father and son exude warmth. Ron Shapiro, unable to stay for the afternoon game, told Mark upon departing, "Give me a kiss and a.hug," and through their embrace the men uttered their mutual love. Their personal-baseball time together here was a weekend to savor. "For me, baseball has always been relational- and nothing is more relational than family," Mark Shapiro said. "My love for baseball has always been tied to my father. And to be able to see that relationship and love for the game shared with my son, and to have my dad here, is incredibly special." Caden gets the whole base- ball-family thing. "It's pretty cool, passing down baseball generation to generation," he said, grasping fhe white sphere. "It's a great experience I'm living with my father and grandfather. Base- ball just runs in our family. I'll pass it on to my grandkids." "Another example is women who carry a mutation in the BRCA1/2 genes and develop cancers almost exclusively in the breast and ovary," said Dr. Evron. "This led to the hypothesis that these tis- sues are 'marked' for cancer predisposition during dif- ferentiation. Searching for these marks may throw light on this process. "Certainly the concept of looking for genes that are involved in both in differentia- tion and in carcinogenesis is promising, and the novel list of breast-specific regulated genes we found may encourage fur- therstudy in this direction. But we can't stop here. If we know which genes are responsible for breast cancer, then we can tailor therapies to target those genes specifically." ABERDEEN, Md. (JTA)-- Standing on a hill on a glorious Sunday morning, Mark and Ron Shapiro are kvelling as they watch Caden Shapiro-- son of Mark and grandson of Ron--pitching in a baseball tournament in this city near Baltimore after having been shelved for nearly two months by a broken ankle. Mark Shapiro, the president of the Cleveland Indians, was back recently in his native area for the three-day competi- tion as a coach for his boy's Cleveland Spiders, not to see his Tribe play the Orioles at nearby Camden Yards. The site for the tourna- ment--a complex of beauti- fully maintained fields--was named for Hall of Famer Cal Ripken, the most recognizable client of his dad, an eminent sports agent. At 11, Caden is the latest Shapiro drawn to baseball, a chain emanating from the A new study finds that gene patterns responsible for normal breast tissue may also play a role in the development of cancer. About one in eight women in the United States will con- tract breast cancer in her life- time. Now new research from Tel Aviv University-affiliated researchers, in collaboration with Johns Hopkins Univer- sity, has provided another tool to helpwomen, clinicians, and scientists searching for a cure to the one of the most wide- spread yet incurable diseases on the planet. Dr. Ella Evron and Dr. Ayelet Avraham of the TAU-affiliated AssafHarofeh Medical Center, together with Prof. Saraswati Sukumar of Johns Hopkins, have found that"gene regula- tion," the process that shuts