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Chemotalk NewsletterChemotalk Newsletter, Vol. 32: December 1, 2010
Hi, All ... This month's Chemotalk is a bit shorter, in keeping with my attention span during the holiday season. And in case anyone out there decides to keep chickens in the city, just remember, they're up at daybreak -- and so are you! HORMONE THERAPY LINKED TO OVARIAN CANCER Post menopausal women who use hormone replacement therapy face a 29% increased risk of ovarian cancer, according to a study. Researchers at the Cancer Epidemiology Unit at the University of Oxford in England analyzed data from the European Prospective Investigation Into Cancer and Nutrition to evaluate the relationship between hormone therapy use during the postmenopausal years and ovarian cancer risk. Hormone Therapy and Risk for Ovarian Cancer Investigators led by Konstantinos Tsilidis, PhD, looked at data on 126,920 postmenopausal women who did not have a history of cancer and who had not had their ovaries removed. During nine years of follow-up, there were 424 cases of ovarian cancer diagnosed. The women were also asked about their height and weight, whether they smoked, use of oral contraceptives, number of pregnancies, and what age they started menstruating. After accounting for other factors, the research team found that:
69% of the group that used hormone therapy took an estrogen-progestin combination, 18% used estrogen-only hormone therapy, 3% used tibolone, and 2% used other preparations of hormone therapy; 8% had missing information on type of hormone use. Current use of any hormone therapy was significantly associated with a 29% increased risk of ovarian cancer compared to women who had never used hormone therapy. Current use of estrogen-only therapy was associated with a 63% increased risk of ovarian cancer. Current use of estrogen-progestin combination therapy was not significantly associated with risk. Women who had ever used some form of hormone therapy for five or more years had a 45% higher risk for ovarian cancer compared with women who had never used hormone therapy. The findings were presented at the Ninth Annual American Association for Cancer Research Frontiers in Cancer Prevention Research Conference held in Philadelphia. Hormone Therapy and Breast Cancer Previous research has shown an association between hormone replacement therapy and an increased risk for breast cancer. A study published last month in The Journal of the American Medical Association found that postmenopausal women who take a combination of estrogen and progestin therapy face a greater risk for developing a more advanced form of breast cancer and an increased risk for dying from the disease. The findings were based on the ongoing Women's Health Initiative, a major research program launched in 1991 by the National Institutes of Health. In the United States, ovarian cancer is the fifth leading cause of cancer death. According to 2006 data from the CDC, 19,994 women in the U.S. were diagnosed with ovarian cancer and 14,857 women died from the disease. * * * FDA EXTENDS PRIORITY REVIEW OF CLADRIBINE FOR RELAPSING-REMITTING MULTIPLE SCLEROSIS The Food and Drug Administration has extended the review period for Cladribine tablets for the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS by another three months, to give time for a comprehensive review of additional information under the NDA (new drug application), Merck KGaA announced today. The Priority Review period¡¯s end has been extended from November 28th 2010 to February 28th 2011. Bernhard Kirschbaum, Head of Global Research and Development. Merck Serono, said ¡°Merck Serono continues to work closely with the FDA during the review process of the Cladribine Tablets new drug application. We will continue working towards our goal of providing an oral disease-modifying drug for the treatment of relapsing multiple sclerosis.¡± Cladribine, chemically known as 2-chlorodeoxyadenosine (2CDA) is an investigational medication for the treatment of relapsing-remitting MS. It is a small molecule, C10H12CIN5O3, and is believed to interfere with the behavior and proliferation of some white blood cells, especially lymphocytes, which experts say play a key role in the MS process. In July 2010, Russian regulators approved Cladribine Tablets, as did the Australian ones in September 2010. The medication is currently being reviewed in other countries. CHMP (Committee for Medicinal Products for Human Use), of the European Medicines Agency did not approve Cladribine in its first NDA, neither did the US FDA. Cladribine is currently indicated for the treatment of SYMPTOMATIC HAIRY CELL LEUKEMIA. With relapsing-remitting MS, the individual has clearly-defined attacks of worsening neurologic function. Relapses are followed by complete recovery periods (remission). There is no disease progression during the remission. Relapses are also known as exacerbations or flare-ups. Approximately 85% of MS patients have Relapsing-Remitting MS. * * * RESEARCHERS FIND FURTHER EVIDENCE LINKING EPSTEIN-BARR VIRUS AND RISK OF MULTIPLE SCLEROSIS Researchers from the Harvard School of Public Health, Walter Reed Army Institute of Research, and a team of collaborators have observed for the first time that the risk of MULTIPLE SCLEROSIS increases by many folds following infection with the Epstein-Barr virus (EBV). This finding implicates EBV as a contributory cause to multiple sclerosis. The study appears in an edition of the journal Annals of Neurology. Hundred of thousands of individuals not infected with EBV were followed up for several years through repeated blood samples collections. Researchers were then able to determine the time when individuals developed an EBV infection and its relation to MS onset. "The recruitment of individuals before they were infected with EBV and following up with them for several years is the critical methodological aspect that makes this study qualitatively different from all previous work," said Alberto Ascherio, senior author of the study and professor of epidemiology and nutrition at Harvard School of Public Health and professor of medicine at Harvard Medical School. MS is a chronic degenerative disease of the central nervous system. Women are more likely than men to get the disease and it is the most common neurologically disabling disease in young adults. Although genetic predisposition plays an important role in determining susceptibility, past studies have shown that environmental factors are equally important. EBV is a herpes virus and one of the most common human viruses worldwide. Infection in early childhood is common and usually asymptomatic. Late age at infection, however, often causes infectious mononucleosis. In the U.S., upwards of 95% of adults are infected with the virus, but free of symptoms. EBV has been associated with some types of CANCER and can cause serious complications when the immune system is suppressed, for example, in TRANSPLANT RECIPIENTS. There is no effective treatment for EBV. This is the first study based on the longitudinal follow-up of several thousand individuals who were not infected with EBV at the time of recruitment. The study population was made up of active-duty US Army, Navy, and Marines personnel who have at least one blood sample in the Department of Defense Serum Repository. The electronic databases of the Physical Disability Agencies of the US Army and Navy were then searched for individuals whose records indicated a possible diagnosis of MS reported between 1992 and 2004. The researchers selected 305 individuals diagnosed with MS and who had blood specimens collected before the date of their diagnosis. Two controls for each case were then selected from the serum database and matched by branch of service, sex, date of blood collection, and age at time of blood collection. The study found that MS risk is extremely low among individuals not infected with EBV, but it increases sharply in the same individuals following EBV infection. "The observation that MS occurred only after EBV is a big step forward," said Alberto Ascherio. "Until now we knew that virtually all MS patients are infected with EBV, but we could not exclude two non-causal explanations for this finding: that EBV infection is a consequence rather than a cause of MS, and that individuals who are EBV negative could be genetically resistant to MS. Both of these explanations are inconsistent with the present findings," said Ascherio. "The evidence is now sufficiently compelling to justify the allocation of more resources to the development of interventions targeting EBV infection, or the immune response to EBV infection, as these may contribute to MS prevention," he said. The study was supported by a grant from the National Institute of Neurological Disorders and Stroke. * * * The following means a lot to me, personally. I've added "extreme exercise" to my daily routine, and I have no doubt whatsoever that that's the one thing within my control, that accounts for my continued excellent health: TO BEST FIGHT CANCER, NEW GUIDELINES URGE EXERCISE People undergoing CANCER treatment traditionally have been told to rest as much as possible and avoid exertion, to save all their strength to battle the dreaded disease. But a growing number of physicians and researchers now say that people who remain physically active as best they can during treatment are more likely to beat cancer. The positive evidence for exercise during and after cancer treatment has piled so high that an American College of Sports Medicine panel is revising the group's national guidelines regarding exercise recommended for cancer survivors. The panel's conclusion: Cancer patients and survivors should strive to get the same amount of exercise recommended for everyone else, about 150 minutes a week of moderate-intensity aerobic exercise. Resistance training and stretching also are recommended. "Exercise is so important for cancer patients, but so many doctors and health professionals are concerned about safety issues -- is it safe for people undergoing treatment to exercise?" said Colleen Doyle, director of nutrition and physical activity at the American Cancer Society. "And this group has decided that yes, it is. These guidelines really help lay some of those issues to rest. This clearly delineates that it is safe and it is feasible and we should be recommending exercise for cancer patients." The new guidelines stand as an important sea change in cancer treatment, said Kathryn Schmitz, an associate professor of epidemiology and biostatistics at the University of Pennsylvania School of Medicine and a researcher at the university's Abramson Cancer Center, who presented the guidelines at a meeting this past summer of the American Society of Clinical Oncology. "The exercise guidelines for all Americans stand for cancer patients undergoing treatment," Schmitz said. "This is a landmark statement because the guidelines up to this point have been, 'Take it easy, don't push yourself.'" But that's changed, she explained. "Not only is exercise safe, but it has a number of benefits for cancer patients during treatment," she said. The top benefit is a better chance of survival. Exercise seems to make the body better able to withstand the withering effects of such cancer treatments as chemotherapy and radiation therapy. "Evidence is promising that exercise may make cancer treatment more effective," Schmitz added. For example, breast cancer patients doing resistance training were better able to take a full dose of chemotherapy, rather than having to cut the treatment short due to the detrimental effects of chemo on the body, she said. Other exercise benefits for cancer patients and survivors include: Reduced fatigue. Aerobic activity has been found to lessen the need for drugs to increase production of red blood cells because of chemo damage. The loss of red blood cells is responsible for much of the crippling fatigue that people often feel while undergoing cancer treatment. "You do need less medical attention for your fatigue during chemotherapy if you are physically active," Schmitz said. Reduced loss of muscle and bone mass. "A lot of patients lose muscle mass and bone density during chemotherapy or hormone therapy," said Dr. Eleanor M. Walker, division director of breast services in the radiation oncology department at Henry Ford Hospital in Detroit and lead author of an ongoing study on exercise for cancer patients. Evidence has found that regular workouts can attenuate the wasting away that comes both from the cancer itself and cancer treatments. Improved quality of life. People with cancer feel better overall when they exercise. Fatigue is less, but there also are emotional benefits to be had. "There's such a sense of fear, such a sense of loss of control, a lot of stress -- and we know that exercise helps calm those fears and restores a sense of control," Doyle said. Doctors do not expect cancer patients to always be able to keep up the same level of physical activity as healthy people. "We understand that a person throwing up because of chemotherapy may have trouble getting that amount of exercise, but they still should be avoiding inactivity as much as they can," Schmitz said. Workout plans also will have to be tweaked to best fit the person's condition, according to the American College of Sports Medicine panel. For example, some types of cancer therapy can make bones more brittle, requiring exercise that places less stress on them. Other cancer patients could be so vulnerable to infection because of their embattled immune system that they would need to exercise away from other people. But overall, the new message is clear: If you have cancer, you'll have a more successful fight against it and a better recovery afterward if you exercise as much as possible. "Our study is potentially showing that even if you don't start your exercise training until you've received your diagnosis, it can still be of some help," Walker said. "And if you're in a healthier state before you get a diagnosis of cancer, you're going to do better because your body is in better shape and you have reserves there." * * * MOST RA PATIENTS STILL NOT TREATED EARLY ENOUGH This study found that the majority of patients with RHEUMATOID ARTHRITIS are not beginning treatment at a time when they are most likely to achieve remission and avoid joint destruction, despite an awareness among rheumatologists about the importance of early treatment. Patients whose diagnosis was delayed for 12 weeks or longer had a 1.34-fold higher rate of radiographic progression of their disease and a higher rate of not achieving a sustained remission. Despite an increasing awareness among rheumatologists of the importance of early treatment in rheumatoid arthritis, the majority of patients still are not beginning treatment at a time when they are most likely to achieve remission and avoid joint destruction, a study conducted in the Netherlands found. Among patients enrolled in the Leiden early arthritis cohort, the hazard ratio for not having sustained remission was 1.87 (95% CI 1.18 to 2.99, P=0.008) among patients not referred within 12 weeks of symptom onset, according to Michael P.M. van der Linden, MD, of Leiden University. Moreover, patients whose diagnosis was delayed for 12 weeks or longer had a 1.34-fold higher rate of radiographic progression of their disease. Experience during the past decade with better and earlier treatments has shown that the 12 weeks after symptom onset can be considered a window of opportunity during which optimal outcomes are likely in rheumatoid arthritis. To explore the effects of delays on treatment outcome, van der Linden and colleagues examined the records of 1,674 patients with early arthritic symptoms seen in the Leiden clinic between 1993 and 2006. A total of 598 of these were subsequently diagnosed with rheumatoid arthritis. Among all the early arthritis patients, the median delay before treatment was 13.7 weeks, and among the rheumatoid arthritis patients, only 31% were evaluated within 12 months. The hazard ratio for not reaching sustained remission remained significant, at 1.87, after adjustment for age, gender, and treatment period. Treatment periods were stratified according to treatment aggressiveness, with patients enrolled between 1993 and 1996 usually being treated initially with analgesics, those first seen between 1996 and 1998 being given chloroquine or sulfasalazine, and those enrolled in 1999 and thereafter receiving prompt therapy with sulfasalazine or methotrexate. The investigators noted that patients seen within 12 weeks had lower rates of radiographic progression -- representing irreversible joint damage -- regardless of treatment period. "Thus, although the increase in aggressiveness of treatment after assessment reduced the overall level of Sharp-van der Heijde [radiographic] scores, this did not diminish the effect of delay in referral," they wrote. The researchers also looked at patient characteristics that were associated with delays in assessment and treatment. On multiple regression analysis, they found significant associations for older age, female gender, gradual onset of symptoms, the involvement of small joints, the presence of autoantibodies, and lower levels of C-reactive protein. Further analysis determined that patients who ultimately were diagnosed with reactive arthritis, crystal arthritis, and sarcoidosis -- conditions with acute onset -- had the shortest delays before assessment. Those with diagnoses characterized by a gradual onset -- rheumatoid arthritis, psoriatic arthritis, and spondylarthropathy -- had the most extensive delays. Yet these are the patients most in need of early rheumatologic consultation, according to the researchers. "Our findings suggest that attention needs to be focused on the education of patients, in particular older and female patients, about the significance of their symptoms, and on the education of [primary care physicians] to rapidly refer patients, particularly those who are older, female, and who have gradual onset of symptoms," they wrote. In an accompanying editorial, Vivian Bykerk, MD, of Brigham and Women's Hospital in Boston, and Paul Emery, MD, of Leeds University in England, noted that a number of studies have found that delays in treatment are common. "However, this is the first time the negative impact of delay to care has actually been documented," the editorialists observed. They also echoed the investigators' call for an increase in education of primary care physicians on the diagnosis of rheumatoid arthritis. Bykerk and Emery recommended that primary care physicians familiarize themselves with the current criteria for diagnosis that have been formulated by the American College of Rheumatology and the European League Against Rheumatism, which emphasize small joint involvement and the measurement of autoantibodies and acute phase reactants. * * * A study that came out yesterday in The New York Times questioning the need for additional Vitamin D added to our diets, does NOT challenge this following story:
LOW VITAMIN D LINKED TO DETERIORATION IN CERTAIN LEUKEMIA PATIENTS Patients with a certain type of LEUKEMIA who had insufficient vitamin D levels when their cancer was diagnosed saw their disease progress much faster and were two times more likely to die than those with adequate vitamin D levels. Researchers also discovered that increasing vitamin D levels in patients was linked to longer survival times, even after controlling for other factors associated with leukemia progression. This is an important finding for both patients and doctors, according to the researchers at the Mayo Clinic in Rochester, Minn. and the University of Iowa. The disease -- chronic lymphocytic leukemia (CLL) -- is cancer of the white blood cells (lymphocytes) and mainly affects adults. Although CLL is often diagnosed at an early stage, the standard approach is to wait until patients develop symptoms before beginning chemotherapy, explained study author and hematologist Dr. Tait Shanafelt. "This watch-and-wait approach is difficult for patients because they feel there is nothing they can do to help themselves," Shanafelt said in a Mayo news release. "It appears vitamin D levels may be a modifiable risk factor for leukemia progression. It is simple for patients to have their vitamin D levels checked by their physicians with a blood test. And if they are deficient, vitamin D supplements are widely available and have minimal side effects." This study of 390 CLL patients found that 30% of them had insufficient vitamin D levels (less than 25 nanograms per milliliter) at the time of cancer diagnosis. After a median follow-up of three years, patients with insufficient vitamin D levels were 66% more likely to have disease progression and to require chemotherapy. They also had a twofold increased risk of death, compared to those with adequate vitamin D levels. Similar findings were seen in a different group of CLL patients who were followed for 10 years. "This tells us that vitamin D insufficiency may be the first potentially modifiable risk factor associated with prognosis in newly diagnosed CLL," Shanafelt said. The researchers are planning another study to see if reversing low vitamin D levels in patients will improve their prognosis. The study appears online in the journal Blood. * * * A DIRECT HIT OF DRUGS TO TREAT BRAIN CANCER By Denise Grady It was a desperate measure for a desperate disease. Fourteen months ago, Dennis Sugrue let doctors thread a fine tube through his blood vessels and up into his head, so they could spray the drug Avastin directly into the part of his brain where a tumor had been cut out. It was an experiment, devised mainly to find out whether the procedure was safe, and to gauge how much Avastin the brain could tolerate. But Mr. Sugrue, then 50, was hoping the experiment would also free him of cancer. He had GLIOBLASTOMA, a brain tumor that fights off every known therapy. The same disease killed Senator Edward M. Kennedy last year. Mr. Sugrue's cancer waas diagnosed in April 2009 and bombarded with the usual weapons: surgery, radiation and CHEMOTHERAPY. Within months, the tumor was growing back. That was when he signed up for the Avastin study. About 10,000 Americans a year develop glioblastoma. Nearly all find that the standard treatments seem to work - for a while. And then the clock starts to run down. With treatment, the median survival is about 15 months. Only 25% of patients make it to two years. The disease is the focus of much research, and will almost certainly be for years to come. Hundreds of studies are being conducted in glioblastoma and other brain cancers. Among other things they involve vaccines, drug combinations and special drug-delivery techniques. Progress is measured in small steps - a few more months of survival, more patients managing to survive two years. On paper the gains may seem minute, but for patients the added time may translate into a graduation or wedding that might otherwise have been missed. There are two enormous obstacles to treating glioblastomas. First, no drug is highly effective. Second, even if there were such a drug, getting it to the tumor would be difficult. Many drugs cannot squeeze through the blood-brain barrier, a system of tightly paced cells lining capillaries in the brain. The barrier makes all brain tumors hard to treat. The study that Mr. Sugrue entered, for people with recurring glioblastomas, is being conducted by Dr. John Boockvar, a brain surgeon at New York-Presbyterian/Weill Cornell. Doctors first inject a substance called mannitol, which temporarily opens the blood-brain barrier, and then flood the tumor zone with Avastin. Avastin blocks the growth of new blood vessels, which tumors need. The drug is approved for glioblastoma, but tumors can become resistant to it. Normally, Avastin is dripped into a vein. But Dr. Boockvar and his colleagues wanted to try hitting the cancer with a much higher dose by guiding tiny tubes called microcatheters through blood vessels to the tumor site and then unleashing the drug. Mr. Sugrue was the second patient to e treated, with a small dose. Since then, the study has shown that higher amounts -- seven times the dose he received -- can be safely used. A report on the first 30 patients was published last month in The Journal of Neurosurgery. Tumors shrank in some, particularly those who had not had Avastin before. But one patient suffered a stroke from the treatment, which caused weakness on one side. And it is stiol too soon to tell whether this approach can prolong survival. "We started a year ago," Dr. Boockvar said, adding that the early patients were quite ill and had only one dose of Avastin. "We've lost about 15, or half the patients. The rest are alive and kicking." His team has begun new experiments using mannitol and microcatheters to deliver other drugs directly into the brain. In the future, certain drugs may be combined with Avastin. Dr. Keith Black, chairman of neurosurgery at Cedars-Sinai Medical Center in Los Angeles and an expert on breaching the blood-brain barrier, said it was not clear that Avastin would work well enough to improve survival very much, even when infused right into the brain. Better drugs are needed. "We can get the rugs in, but there's a belief in glioblastoma, for example, that even if you push the limit of the drugs you still won't increase the survival all that much," Dr. Black said. "It's kind of like having the Trojan horse before we have the soldiers to put in it." He said vaccines looked promising for some patients with glioblastoma. In addition, research with animals suggests that Viagra or Levitra -- the drugs for erectile dysfunction -- can open the blood-brain barrier, particularly around tumors, and let chemotherapy in. In theory, the drugs could be taken in pill form, unlike mannitol. Dr. Black said he was planning to study the idea in people with various types of brain tumors, including those that had spread from other sites, like the breast or lung. Cancer from other organs invades the brain in about 100,000 Americans a year. The study that Mr. Sugrue entered is still going on. And so is Mr. Sugrue. He lives in Stamford, Conn., with his wife, Donna, and their teenage children, Molly and Tim. Molly, a high school senior, is about to apply to nursing schools. Mr. Sugrue is still receiving intravenous Avastin regularly. (He had only one dose infused into his brain.) There is no sign of tumor recurrence. But it has not been an easy year. An infection in his incision required many operations. He has lost some peripheral vision and no longer dries. He needs physical and occupational therapy. Though he does some work, he has not been able to return full time to his job a a hedge fund. But he never lost his quick wit or sense of humor, his wife said, adding, "What he went through would have killed a lesser man." If he had to do it again, would he enter the study? "Absolutely," Mr. Sugrue said. "In fact, I'm going to ask Dr. Boockvar if there are any more trials out there." * * * Finally ... Coming Down The Road IMMUNOGEN, INC. ANNOUNCES PRESENTATION OF DATA FOR LORVOTUZUMAB MERTANSINE ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted ANTICANCER therapeutics using its Targeted Antibody Payload (TAP) technology, announced the presentation of encouraging clinical data for the Company's lorvotuzumab mertansine (IMGN901) targeted anticancer compound at the 35th European Society for Medical Oncology (ESMO) Conference. Lorvotuzumab mertansine is designed to target and kill cancer cells that express CD56, a protein. This targeted anticancer compound is a potential treatment for Merkel cell carcinoma (MCC), small-cell lung cancer (SCLC), ovarian cancer, multiple myeloma, and other CD56+ tumors. The data reported are from an early-stage clinical trial evaluating lorvotuzumab mertansine in CD56+ solid tumors. During the dose-escalation phase of the trial, patients with any type of CD56+ solid tumor were eligible for enrollment. In the ongoing expansion phase of the trial, enrollment is limited to patients with MCC, SCLC, or ovarian cancer. A total of 64 patients with CD56+ solid tumors had been enrolled at the time of data cut-off for presentation. Among these, 45 patients could be quantitatively assessed for changes in overall tumor burden. Thirteen (29%) of these 45 patients had a reduction in tumor volume ranging from 1.3 - 100%, and another 10 patients (22%) had no discernable increase in tumor burden. Findings in Merkel Cell Carcinoma Patients with Merkel cell carcinoma are being enrolled in the expansion phase of this trial as promising activity has been reported with lorvotuzumab mertansine for MCC, and the Company is assessing whether to initiate a pivotal trial with the compound for this use. Metastatic MCC is a rare and aggressive neuroendocrine cancer of the skin. Among patients diagnosed with metastatic MCC, median survival is less than seven months. There are no approved therapies for metastatic MCC, and typically the disease progresses rapidly (within 1 to 2 months) on the therapies currently used. Thirteen patients with metastatic MCC had been enrolled in the study at the time of data cut off. Five (38%) of these patients had notable clinical benefit:
Twenty-six patients were enrolled with Small Cell Lung Cancer, which has commonalities with MCC in biological characteristics, clinical course and response to treatments. SCLC tumors generally respond to first-line treatment but then recur. Survival at that stage is usually less than 6 months. While all of the SCLC patients enrolled in this trial had cancer that had recurred following treatment with other therapies, three patients had clinically meaningful stable disease and another patient with refractory disease achieved an unconfirmed PR. ImmunoGen plans to begin a study later this year to assess lorvotuzumab mertansine for first-line treatment of SCLC used in combination with standard care. "These findings are encouraging in light of the prior treatments these patients have received and the stage of their disease at the time of study entry," commented James O'Leary, MD, Vice President and Chief Medical Officer. "We believe it's important to assess lorvotuzumab mertansine as part of a combination regimen, as cancer is typically treated with several agents with different mechanisms of action. The combination trial planned in SCLC and the one underway in multiple myeloma are expected to be particularly significant to determining the potential opportunity for this compound." The patients enrolled at the time of data cut-off for presentation consisted of 26 patients with SCLC, 16 with neuroendocrine tumors, 13 with MCC, and 9 patients with other types of CD56+ solid tumors. The first ovarian patient entered the study after that time. In the expansion phase of the trial, lorvotuzumab mertansine is being administered at a dose of 60 mg/m©÷/day for three consecutive days every 21 days. Lorvotuzumab mertansine, a TAP compound, consists of a CD56-binding antibody with ImmunoGen's potent cancer-cell killing agent, DM1, attached to it using one of the Company's engineered linkers. Lorvotuzumab mertansine has been granted orphan drug designation for MCC in the US and Europe. It also has been granted orphan drug status for SCLC in the US and is in the process of receiving this designation in Europe. MCC is an aggressive neuroendocrine cancer of the skin that typically occurs on the head/neck, most often in individuals of European ancestry. There are approximately 1,900 new cases of MCC diagnosed in the US each year, with the incidence considered to be increasing. An estimated 28,000 new cases of SCLC are expected to be diagnosed in the US in 2010, and 22,000 new cases of ovarian cancer. Based on published literature and Company research, CD56 is expressed on virtually all cases of MCC and SCLC and on approximately 58% of ovarian cancer tumors. ImmunoGen, Inc. develops targeted anticancer therapeutics using the Company's expertise in tumor biology, monoclonal antibodies and potent cancer-cell killing agents. The Company's TAP technology uses monoclonal antibodies to deliver one of ImmunoGen's proprietary cancer-cell killing agents specifically to tumor cells. There are currently seven TAP compounds in the clinic, with a wealth of clinical data reported with the technology. ImmunoGen collaborative partners include Amgen, Bayer Schering Pharma, Biogen Idec, Biotest, Genentech (a member of the Roche Group), Novartis, and sanofi-aventis. The most advanced compound using ImmunoGen's TAP technology, T-DM1, is in Phase III testing through the Company's collaboration with Genentech. * * * And REALLY finally, a shout-out to all of our doctors, physician's assistants, office staff, nurses, researchers, technicians, drug companies - yes, drug companies! - who keep us alive. Thank you all. We don't say this enough, because it can't be said too often. See you next year! * * * And if you have any thoughts of how this newsletter could be improved, please email me directly, at jesmer_e@pacbell.net Elaine Jesmer
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