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Biotech / Medical : Novartis -- Ignore unavailable to you. Want to Upgrade?

To: Grateful Reaper who wrote (256)	12/4/1999 3:33:00 PM
From: gao seng	Read Replies (1) \| Respond to of 296

It moved up a couple of points after initial news release came out. Here's the latest, don't know if B43 is Novartis or not though. Saturday, December 4 11:31 AM SGT Promising leukemia drugs could change the face of cancer treatment CHICAGO, Dec 3 (AFP) - Two new experimental leukemia drugs may halt the progress of the deadly disease and could revolutionise its treatment, American researchers said Friday. Both drugs have only been tested on small groups of volunteers, but were very effective in securing remission of their cancers, the teams from Minnesota and Oregon said. The "smart bomb," so-called because they home in on cancer cells, also have minimal or no known side effects, unlike conventional chemotherapy which is highly toxic. "The potential significance of this type of research extends beyond leukemia," said Brian Druker, a researcher at Oregon Health Sciences University. "One of the major goals of cancer research has been to identify differences between cancer cells and normal cells so that these differences can be targetted with more effective and less toxic treatments." The Orgeon team reported a 100 percent success rate with its experimental pill STI-571, which was used to treat chronic myelogenous leukemia. All 31 volunteers involved in the pilot study reported a complete normalisation of their blood counts, signaling a remission of their disease. A larger trial is planned in 2000, Drucker said. The drug acts by inhibiting the activity of BCR-ABL, an abnormal enzyme which causes an overabundance of white blood cells, Drucker said in a statement. In the Minnesota pilot study, doctors were able to halt the progress of lymph cancer using an experimental pill that acts in the same way. The compound, B43-Genistein, completely wiped out the cancer cells in four out of the 10 volunteers who were in the final stages of lymph cancer, Dr Fatih Uckun of the Hughes Institute in Roseville, Minnesota said. The volunteers in the pilot study were given just one cycle of the drug, but one of them is still free from the cancer three years on without any follow-up treatments, Uckun said. Researchers are now testing the experimental therapy on 35 patients at centers across the United States. "The results are encouraging. Everyone in the new study is either stable or improving," said Uckun, director of the Hughes Institute and its Parker Hughes Cancer Center. The drug combines an antibody (B43) which allows the drug to latch on to a receptor cell (CD19) on the surface of the cancer cell with a synthetic chemical called genistein, which blocks the action of the enzyme LYN tyrosine that keeps the cells alive. The receptor cell is present in 85 percent of lymphoid leukemia cases, -- the most common form of childhood cancer. A child dies of leukemia every 15 minutes around the globe; the disease claims 70,000 young lives every year, Uckun noted. fullcoverage.yahoo.com ________ Hughes Institute: Clinical Trial Results Offer New Hope for Patients Suffering From Leukemia PR Newswire - December 02, 1999 14:58 Jump to first matched term ST. PAUL, Minn., Dec. 2 /PRNewswire/ -- A new drug for treating leukemia has been tested in children and adults and has shown very promising results in the first clinical study. This new agent, B43-Genistein, was developed by scientists at the Hughes Institute. Results of this study are reported in the December issue of Clinical Cancer Research, official journal of the American Association of Cancer Research. The study was conducted at the University of Minnesota, Norris Cancer Center-University of Southern California, University of Iowa Hospitals and Clinics, Cedar Sinai Medical Center, and University of Wisconsin, Milwaukee. Seven children and eight adults with CD19+ B-lineage acute lymphoblastic leukemia and one adult with chronic lymphocytic leukemia were treated with B43-Genistein. All patients tolerated it well with no severe side effects and three patients who relapsed after bone marrow transplantation achieved improvement or a remission. One of these patients is now alive, free of leukemia for three years. B43-Genistein inhibits the activity of LYN tyrosine kinase, an enzyme linked to several types of cancer and may provide the basis for an effective treatment strategy for patients with ALL who have failed standard therapy. This study marks the first time a cell-type specific tyrosine kinase inhibitor has been used in leukemia patients. Leukemia is the number one disease killer of children and each year it, and related cancers, strike approximately 97,000 Americans and kill 55,000. "The most exciting feature of B43-Genistein is that it kills cancer cells at very low doses and yet at even 1,000 times higher doses it causes no detectable toxicity side effects," said Dr. Fatih Uckun, director, Hughes Institute. News of the development of this "smart bomb" was first reported in Science, February, 1995. That study was the first to show that molecule, LYN protein tyrosine kinase, was essential for the survival of leukemia cells. Research also showed that a synthetic chemical, genistein, could block the action of the kinase. In order to get the genistein inside the cancer cells it is joined to B43, an antibody which attaches directly to CD19, a receptor found on the cancer cells. It thus attacks and instantly kills leukemia cells without harming normal cells. References: Uckun FM, Messinger Y, Chen CL, O'Neill K, Myers DE, Goldman F, Hurvitz C, Casper JT, Levine A. Treatment of therapy-refractory B-lineage acute lymphoblastic leukemia with an apoptosis-inducing CD19-directed tyrosine kinase inhibitor. Clinical Cancer Research, 5:3906-3913, 1999. Uckun FM, Evans WE, Forsyth CJ, Waddick KG, T-Ahlgren L, Chelstrom LM, Burkhardt A, Bolen J, Myers DE. Biotherapy of B-cell precursor leukemia by targeting genistein to CD19-associated tyrosine kinases. Science 267:886-891, 1995. The Hughes Institute ( hughesinstitute.org ), located in Roseville, Minn., is a non-profit research organization dedicated to combating cancer, AIDS, and diseases of the immune system. SOURCE Hughes Institute /CONTACT: Susan Mau Larson of Hughes Institute, 651-697-9228 ext. 679, cell 612-209-0754/

To: Grateful Reaper who wrote (256)	12/6/1999 8:21:00 AM
From: gao seng	Read Replies (1) \| Respond to of 296

Leukemia Drug Gets Dramatic Results; Volunteers Sought Researchers at UCLA's Jonsson Cancer Center are seeking patients with chronic myelogenous leukemia (CML) to participate in a study of a new experimental drug that has resulted in dramatic responses in some patients in early testing. Dr. Charles Sawyers, a co-investigator who led the phase one trials at UCLA's Jonsson Cancer Center, said he is "tremendously encouraged" by results from early testing of the experimental drug STI-571, being developed by Novartis Pharmaceuticals. The drug, taken once a day in pill form, is a targeted therapy, meaning it attacks only cancer cells and leaves healthy cells alone. Targeted therapies often result in few, if any, side effects for patients, Sawyers said. Results of phase one testing of STI-571 were announced Sunday (Dec. 5) at the American Society of Hematology conference in New Orleans by Dr. Brian Druker of Oregon Health Sciences University, who served as lead investigator for the phase one study. The three institutions that tested STI-571 include UCLA's Jonsson Cancer Center, Oregon Health Sciences University and the M.D. Anderson Cancer Center in Houston. Dr. Moshe Talpaz led clinical trials at M.D. Anderson. Novartis officials are discussing with the U.S. Food & Drug Administration (FDA) the possibility of accelerating the testing process of STI-571 because of the encouraging early results. Second phase testing of STI-571, to take place at UCLA and 18 other sites in the United States and Europe, is expected to begin this month. At UCLA's Jonsson Cancer Center, 24 patients in the chronic stage of CML are enrolled in the phase one testing of the experimental drug. Sawyers said nearly all have done well so far. "I think this is tremendously exciting, a confirmation of the rationale of targeted therapies in drug design," said Sawyers, associate chief for basic research at UCLA's Jonsson Cancer Center and an associate professor in the Division of Hematology-Oncology at the UCLA School of Medicine. "This drug attacks a mutant protein without harming surrounding normal cells." Specifically, STI-571 attacks a mutant protein in a cancer-causing gene linked to CML, which strikes more than 4,300 adults in the United States every year. Much of the pioneering work done to link the gene and its mutant protein with CML was done at UCLA's Jonsson Cancer Center by researcher Owen Witte, a professor of microbiology and a renowned investigator with the Howard Hughes Medical Institute. Sawyers, who did his postdoctoral training with Dr. Witte, participated in the research linking the mutant gene with CML. In the chronic stage of CML, patients experience skyrocketing white blood cell counts, but generally exhibit no symptoms for three to five years. The disease can then advance to the accelerated stage, during which white blood cell counts increase even more. The end stage of the disease, known as blast crisis, can be fatal within several months. Early testing of STI-571 at UCLA focused on patients in the chronic stage of the disease who did not respond to standard treatments with interferon. At doses of around 200 mg of STI-571, nearly all the patients had their white blood cell counts return to normal levels. At higher doses, the molecular cause of the disease -- the genetic mutation -- disappeared in some of the cases, Sawyers said. Seth Shapiro, a 35-year-old designer of computer games for children, was among those UCLA patients whose white blood cell counts returned to normal levels after taking the experimental drug. Shapiro said his white blood cell counts were normal within three weeks of taking STI-571. Shapiro was diagnosed in April of 1998 with CML. After interferon failed to help him, instead prompting a host of debilitating side effects such as extreme fatigue and depression, Shapiro began taking STI-571 in February of this year. "I feel like I've gotten my life back," said Shapiro, who lives in Los Angeles. "For the first time in more than a year, I don't worry about being sick every day. When I got my diagnosis, I felt like I was out of the race. Now I'm back in the game. I believe this drug saved my life." Shapiro said he has experienced few side effects from the experimental drug. Better still, he's back "at full speed," working at the job he loves and enjoying his busy life -- something he never thought he'd be able to do when he was diagnosed with CML. "I can do just about anything I want now. It's almost as if my leukemia is now a chronic disease like diabetes," he said. "That's the greatest gift you can ever get. Life is not over for me, and that's pretty amazing." Virginia Garner, a 54-year-old high school English teacher from Claremont, also participated in the phase one testing of STI-571 at UCLA's Jonsson Cancer Center. Diagnosed with CML in August of 1997, Garner underwent interferon treatments and experienced what she characterized as "extreme side effects." She began taking STI-571 last April and saw a measurable response in her white blood cell count within five months. She's back in the classroom and living a full life, including taking a recent dream vacation with her husband to Viet Nam. "I have a feeling about this new drug, that it's going to turn out to be something everyone is going to be amazed at," Garner said. "Those are precious pills." With interferon, the current standard therapy for CML, a small fraction of patients are cured, Sawyers said. Most relapse. A bone marrow transplant also can help, but Sawyers said fewer than 20 percent of CML patients qualify. "I believe that in five years or sooner this drug will be the front-line therapy for CML if the results hold up as they have in the first phase of testing," Sawyers said. "I want to stress that this validates a whole concept of drug development: That through basic science we can understand what's wrong with a cancer cell and actually fix it." Dr. Harmon Eyre of the American Cancer Society said it's rare to see a response in Phase One testing of experimental drugs. But in this case, the testing has resulted in very good responses early on, which he calls "very exciting." Each year, more than 4,300 new cases of CML are diagnosed in the United States, according to the American Cancer Society. Of those cases, about 2,400 will result in death. Because the chronic stage of the disease can last up to five years, the population of adults living with CML continues to increase, officials from the American Cancer Society said. For more information about the Phase Two testing of STI-571 at UCLA's Jonsson Cancer Center, or to volunteer to participate in the study, please call 310-794-4928. - By Kim Irwin unisci.com