JAK inhibitor shows promise for patients with myelofibrosis. According to data from the largest-ever trial of patients with the incurable bone marrow disease, "Half of patients with myelofibrosis had major clinical responses to an investigational inhibitor of Janus activated kinase (JAK). A Houston oncologist also said during a press briefing at the American Society of Hematology meeting that after "follow-up for at least a year, 48% of 155 patients had greater than a 50% reduction in splenomegaly." The oncologist added, "More than 75% of the patients are still on the study after an average of 16 months, meaning the patients benefit and the drug is safe." New approach to treating hepatitis C said to look promising. An experimental antiviral drug that works by a different mechanism than existing drugs has been shown to suppress hepatitis C in chimpanzees," according to a paper in Science. In fact, "preliminary tests suggest that the drug, called SPC3649, has no toxic side effects, does not allow development of resistance -- which plagues other hepatitis drugs -- and has lasting effects after treatment has stopped." Apparently, "the new drug outwits the virus by targeting not the virus itself, but a short piece of RNA in cells" -- miR-122 -- "that is crucial to" replication. The "standard treatment is a two-drug cocktail of interferon...and ribavirin, an antiviral, which cures about half of those infected." The side effects, however, "can be grueling," and for "those who don't respond to the two-drug cocktail, there are few options." Enter the team at Southwest Foundation for Biomedical Research. The group "studied four chimps chronically infected with HCV genotype 1 and noted two chimps got a low dose of SPC3649, and two got a high dose, given once a week for 12 weeks. The higher-dose treatment was remarkably effective in suppressing HCV." Specifically, "HCV levels drop 350-fold in chimps treated with SPC3649." The team also pointed out that the "lower dose showed a strong but lesser effect in one chimp, but not in the other." Treatment also "made the virus much more sensitive to the antiviral effects of interferon." The study further reported, "also showed the technology could prove useful in the treatment of other diseases, including HIV, cancer, and inflammatory diseases." As for its current applications, the treatment, developed by Santaris Pharma A/S, is "undergoing 'human clinical trials and is currently undergoing Phase 1 clinical studies in healthy volunteers." Postmenopausal women taking antidepressants may be at higher stroke, death risk. According to a study published in the J.Archives of Internal Medicine, "postmenopausal women who take anti-depressants face a small -- but statistically significant -- increased risk of a stroke." In a study "based on" data from the Women's Health Initiative Study on "136,293 women aged 50 to 79, who were followed for an average of six years," Harvard Medical School researchers found that "antidepressant users were 45% more likely to have a stroke than women not taking the" medications. Further, "women taking antidepressants also had a 32% higher risk of death from all causes." While "the absolute risk of stroke was very small -- 0.43% a year versus 0.3% for women not on antidepressants," the fact that "so many people take the pills" may "have a significant impact at the population level, said the scientists." Moreover, "no difference in stroke risk was found between the two major classes of antidepressant, selective serotonin reuptake inhibitors (SSRIs)...and tricyclic antidepressants." SSRIs, however, "were more associated with bleeding in the brain." The investigators, admitted they could not rule out the possibility of underlying depression contributing to stroke risk. Study lead author and psychiatrist Jordan Smoller, MD, stated, "While this study did find an association between antidepressants and cardiovascular events, additional research needs to be done to determine exactly what it signifies." Dr. Smoller added, "Older women taking antidepressants, like everyone else, should also work on modifying their other risk factors for cardiovascular disease, such as maintaining a healthy weight and controlling cholesterol levels and blood pressure." The finding underscores what women have come to learn from a wide range of studies, including several that have emerged from the Women's Health Initiative: It's important to know whether you are at high or low risk of something like stroke before allowing a study like this to sway a decision to take medication for depression, and that's a conversation to be had with a physician who knows your medical history."
FDA approves longer-lasting version of Zyprexa. Eli Lilly & Co. said regulators have approved a longer-lasting version of its top-selling drug, the anti-psychotic Zyprexa [olanzapine]." The FDA "approved Zyprexa Relprevv, an injection that can last up to four weeks, for the treatment of schizophrenia in adults." Lilly spokeswoman Janell Smith said for the new version, patients "will visit their doctors every two or four weeks -- depending on their dosage -- to receive the injection."The approval "could bring some much-needed profit to Lilly" because the drugmaker "will lose most of the $4.7 billion a year Zyprexa now generates in revenue when cheaper generic versions of the drug hit the market two years from now." In addition, despite some initial concerns from the FDA, Lilly worked with the agency "to develop a mandatory patient care program, which restricts distribution of Zyprexa Realprevv to medical professionals or patients enrolled in the program." Also at http://www.pharm-education.com/2009/12/drug-clinical-research-updates.htmlDisclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Eye drops containing tamarind seed extract may help fight dry-eye syndrome. Tamarind fruit extract could help millions combat dry-eye syndrome." The new "seed extract mimics the behaviour of natural tears, helping to keep the eye surface lubricated and repair damage from dehydration." The eye drops are a combination of "hyaluronic acid, which can restore and maintain hydration by reducing fluid loss from the eye, and tamarind seed polysaccharide," both of which work together to "repair the...watery surface layer of the eye."
Australian study suggests children, infants only need one H1N1 vaccine dose. A study by Australian researchers found children and infants only need one does of H1N1 vaccine for effective immunity to the disease. If confirmed, the results "could help damp the spread of the virus by reducing the logistical complications associated with the currently recommended regimen of two doses." However, US health authorities "will not change their recommendations for children." In an editorial accompanying the report in the Journal of the American Medical Association, they note "that the Australian study used twice the dosage of viral antigen found in US vaccines" and the study directly contradicts previous research. Dr. Anthony Fiore, at the CDC's National Center for Infectious Diseases, wrote in the editorial, "Until you can show that a single dose is as effective as two, it's probably too soon to pull away from the two-dose recommendation." Cephalon's Treanda may delay cancer growth better than CHOP cocktail. Cephalon, Inc.'s cancer drug Treanda [bendamustine] worked better than a standard chemotherapy regimen when paired with Roche Holding AG's Rituxan [rituximab] to slow the progression of certain lymphomas," according to findings reported at the American Society of Hematology meeting. The standard cocktail, known as CHOP, "includes four medicines: the chemotherapies cyclophosphamide, adriamycin, vincristine and the steroid prednisone." Researchers found that in patients with "cancers known as follicular, indolent, or mantle-cell lymphomas," Treanda "delayed cancer growth for 55 months, compared with 35 months for those taking the regimen known as CHOP." Bendamustine (Treanda) could replace the so-called CHOP regimen as the optimal partner with rituximab (Rituxan) as the standard first-line treatment for indolent and mantle cell lymphomas, researchers said." In fact, "the combination of bendamustine and rituximab showed substantially lower toxicity and better complete response rates in a randomized Phase III trial," according to a German researcher. The researcher also said the bendamustine-rituximab combination "'has the potential to become the new standard of care' for follicular lymphoma, mantle cell lymphoma, and other indolent forms of lymphoma." Pradaxa may be as safe, effective as warfarin. Blood-thinning pill Pradaxa [dabigatran] may provide a more convenient alternative to" warfarin, "the standard therapy for potentially deadly clots," according to a study published in the New England Journal of Medicine and presented at the American Society of Hematology conference. Pradaxa "'is a far more convenient drug,' since levels in the body don't react with foods and other medicines the way warfarin does, researchers...wrote in the study." The investigators found that "Pradaxa reduced the risk of bleeding by 29 percent compared with warfarin." There were no significant differences in safety outcomes, including bleeding events, acute coronary syndrome, and abnormal liver function tests," according to the researchers. Defibrotide may prevent VOD in children, adolescents undergoing stem cell transplants. The investigational drug defibrotide helped prevent hepatic veno-occlusive disease (VOD) in children and adolescents undergoing stem cell transplants for leukemia, researchers said" at the American Society of Hematology's meeting. Selim Corbacioglu, MD, of Germany's University of Ulm, said "VOD developed in 12% of young patients receiving the drug prophylactically, compared with 20% of a placebo group in a randomized, 360-patient trial." Corbacioglu also said that overall, "VOD at day 30 post-transplant was seen in 23% of infants, 14% of children, and 13% of adolescents," and "defibrotide was significantly more effective than placebo in several secondary endpoints." Omapro confirms results in study of patients with CML. ChemGenex Pharmaceuticals Ltd., an unprofitable Australian drugmaker, said its experimental leukemia drug," called Omapro (omacetaxine mepesuccinate), "cleared the disease in 86 percent of patients, confirming results under review by US and European regulators." The study of 81 patients with "chronic myeloid leukemia, or CML," showed that the drug "also eradicated the disease from bone marrow in 18 percent of patients with an early stage of the blood cancer, potentially allowing them to receive marrow transplants and be cured of the disease." The drug also "is the first to treat the five percent of CML patients who have a gene mutation that makes them resistant to Novartis AG's Gleevec" [imatinib], and ChemGenex "has said it expects FDA approval by mid-2010." Also at http://www.pharm-education.com/2009/12/drug-research-updates_30.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Experimental psoriasis drug meets key midstage clinical trial goals. Celgene Corp. announced Dec. 15 that "its experimental psoriasis treatment, apremilast, met key goals in a midstage clinical trial." Specifically, the drug "reduced the severity of moderate-to-severe psoriasis" in "41 percent of patients receiving the 30-milligram dose...compared with only six percent taking placebo." The company may "advance the drug candidate to late-stage development in 2010. It reported that if apremilast is successful, it will compete against the injectable TNF-inhibitor Enbrel (etanercept). Enbrel is manufactured by Amgen, Inc. Gilead's hypertension treatment candidate fails to meet main trial goal. Gilead Sciences, Inc. said that its high blood pressure treatment candidate, darusentan, failed to meet the main goal of a late-stage clinical trial when compared to a placebo." Company executives found the result "disappointing, and...think it would be challenging to define an expedient path forward”.Bevacizumab plus chemotherapy may modestly improve survival in metastatic breast cancer. According to findings from two trials reported at the San Antonio Breast Cancer, Bevacizumab (Avastin) only modestly improves progression-free survival for metastatic breast cancer when added to chemotherapy. In both trials, researchers found that "the gain was statistically significant, but averaged only one to two months compared with chemotherapy alone." Furthermore, "neither trial showed a significant survival advantage with the addition of the biologic agent." The researchers noted that "given the drug's expense -- roughly $30,000 to $40,000 a month," bevacizumab is "definitely not a home run." Tarenflurbil appears to have no effect on cognition, activities of daily living in early Alzheimer's. According to a study published Dec. 16 in the Journal of the American Medical Association, "tarenflurbil (Flurizan, Myriad Genetics), a gamma-secretase modulator, has no effect on cognition or activities of daily living (ADL)...in patients with mild" Alzheimer's disease. In a "large phase 3, randomized, placebo-controlled trial" of 1,684 patients with mild Alzheimer's disease, Boston University School of Medicine researchers found "virtually no difference between patients receiving active therapy vs. placebo controls at 18 months in either coprimary endpoints of cognition or ADL." They also found "no differences between the two treatment groups on secondary outcome measures." FDA approves olanzapine for adolescents with schizophrenia, bipolar disorder. Eli Lilly & Co. the FDA approved "its best-selling medication Zyprexa [olanzapine] for adolescents with schizophrenia and" bipolar disorder. Specifically, the agency "approved the drug for adolescents aged 13 to 17 years old, but cautioned that the" medicine "can cause weight gain and high blood sugar in younger patients." FDA however supposedly recommended doctors consider prescribing it after other medicines because of its side effects," because olanzapine "has been linked to weight gain and metabolic changes in adolescents." In June, "outside advisers to the FDA ruled...that Zyprexa was 'acceptably safe' for teens who don't improve with other treatments." FDA extends review of Nuvigil for jet lag by three months. FDA extended its review of Cephalon Inc.'s drug Nuvigil [armodafinil] as a treatment for jet lag by three months. According to Cephalon, after it submitted new information about Nuvigil, "the agency decided it needed more time to review its application." A decision is expected by March 29, 2010. Shionogi to stick with velneperit despite failed study.Japanese drugmaker Shionogi & Co. "plans to stick with velneperit, an experimental obesity drug, after one of two key studies failed and Merck & Co., Johnson & Johnson and GlaxoSmithKline Plc abandoned similar treatments." In one clinical test, the company found that "35 percent of patients on a restricted diet who took velneperit for 54 weeks lost more than five percent of their weight, almost three times the proportion for those who were given a dummy pill." But, "in the other test, there was little weight-loss difference between patients taking the drug and those on placebo." The drugmaker said "it is sticking with velneperit because the treatment shows more promise than Merck's MK-0557." Vitamin E extract may shrink tumors within 24 hours. A vitamin jab that shrinks tumors in a day is being hailed as a powerful new treatment for cancer. Researchers at the University of Glasgow and the University of Strathclyde found that "injecting an extract of vitamin E," called tocotrienol, "into the bloodstream" shrank tumors "within 24 hours...and after ten days they had almost completely disappeared." The study targeted skin cancers by disguising tocotrienol "inside thousands of microscopic bubbles made from fat," which travelled "through the body without damaging healthy cells." Also at http://www.pharm-education.com/2009/12/drug-research-updates_29.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Merck begins late-stage study of potential lung cancer vaccine.
Oncothyreon Inc. Reported that its partner Merck KGaA started a late-stage study on Stimuvax as a potential lung cancer treatment." Oncothyreon "said the study is expected to enroll 420 patients with inoperable, stage 3 lung cancer in China, Singapore, South Korea, and Taiwan," and the "key goal is overall patient survival." Stimuvax "is also currently being studied as a potential breast cancer treatment." Additionally, Stimuvax is a vaccine, and the trial aims to target patients with advanced non-small cell lung cancer. High dose of fulvestrant may reduce risk of breast cancer progression. A high dose of its drug Faslodex [fulvestrant] reduced the risk of breast cancer progressing by 20 percent in patients during a late-stage study reports a study from Astra Zeneca. The study "compared a 500-milligram dose versus a currently approved 250-milligram dose in postmenopausal women with advanced breast cancer" and found that the "higher dose pushed back to 6.5 months from 5.5 months the amount of time it took for breast cancer to progress in patients." Denosumab may cut risk of skeletal related events in patients with advanced breast cancer. According to results of phase III trials presented at the San Antonio Breast Cancer Symposium, Amgen, Inc.'s bone drug denosumab cut the risk of multiple skeletal related events, such as fracture, radiation, and surgery on bones, or spinal cord compression, in patients with advanced breast cancer by 23 percent compared to Novartis AG's Zometa (zoledronic acid). Researchers also found that the drug delayed the first occurrence of these events. The FDA delayed approval of denosumab for osteoporosis in postmenopausal women, seeking additional safety data. Varicella vaccine may offer shingles protection. According to data in the Pediatric Infectious Disease Journal, Investigators at the Kaiser Permanente Department of Research "Children who are vaccinated against chicken pox may also have increased protection against shingles based on health records of 172,163 children in southern California who were vaccinated with the varicella (chicken pox) vaccine between 2002 and 2008." They noted that "over an average of 2.5 years after receiving the chicken pox vaccine, only 122 cases of shingles (Herpes zoster) occurred among the children, an estimated incidence of one case per 3,700 children per year." A lower rate than that previously recorded, as prior to vaccination becoming readily available, the incidence of H. zoster infection in children aged five to nine years and in those aged 14 years or younger was reported to be 30 and 46 cases per 100,000 person years, respectively." And, "of the children with H. zoster, 0.7%, 11.1%, 8.3%, and 2.1% had lymphoid leukemia, had asthma with three or more acute exacerbations, had developmental disorders, or had psychological or mental disorders, respectively," leading the authors to conclude that "despite the small numbers, the roles of delayed vaccination, severe asthma, and development disorders warrant further investigation." FDA approves extended release quetiapine as add-on treatment for MDD. Astra Zeneca PLC announced that the FDA approved its schizophrenia medication Seroquel XR [quetiapine] "as an add-on treatment for major depressive disorder (MDD)." But, the drugmaker said that the FDA "has asked for more information before allowing the drug's use as a single agent to treat [MDD]." The AP noted that "Seroquel XR is an extended-release version of AstraZeneca's schizophrenia medication Seroquel," which "is already approved for bipolar disorder and schizophrenia." Seroquel is an atypical antipsychotic whose side effects include tardive dyskinesia and weight gain. AstraZeneca said that the FDA approved adding Seroquel XR to current depression treatment in patients only if that treatment is not working properly. The pharmaceutical company did not disclose, however, what further information the agency is looking for with regard to Seroquel XR as a primary treatment for depression. Novel form of trastuzumab may improve outcomes in metastatic breast cancer. According to research presented at the San Antonio Breast Cancer Symposium, "a new targeted cancer drug has been shown to shrink tumors in women with metastatic breast cancer after an average of seven other drugs, including Herceptin [trastuzumab], failed." The experimental drug, T-DM1, "combines Herceptin with a potent chemotherapy drug" that allows Herceptin to bind to and block "the HER2 receptor that appears on the surface of some breast cancer cells." This mechanism delivers "the cancer-killing agent directly" to the cancer cells. In a study of "110 women assigned to open-label treatment with single agent trastuzumab-DM1," researchers found that "median progression-free survival was 7.3 months" with T-DM1. Meanwhile, "the objective response rate was 32.7 percent in women whose tumors had progressed after treatment with an anthracycline, taxane, capecitabine (Xeloda), trastuzumab, and lapatinib (Tykerb)." Also at http://www.pharm-education.com/2009/12/drug-research-updates_7254.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Carfilzomib may benefit patients with relapsed, refractory multiple myeloma.
According to findings reported at the American Society of Hematology meeting, "An investigational proteasome inhibitor led to major responses in about half of patients with relapsed and refractory multiple myeloma," In an ongoing trial of 59 patients, researchers found that "treatment with carfilzomib led to objective response in 25 of 54 (46 percent) evaluable patients, including one complete response and five very good partial responses." The study showed "a disease control rate of 83 percent," with "median response duration" at "8.8 months in patients who had a minor response or better result," and "8.4 months in those who achieved at least a partial response."
Ofatumumab not viable option for patients with follicular lymphoma who failed rituximab.
According to research reported at the American Society of Hematology meeting, "Ofatumumab (Arzerra) monotherapy is not a viable treatment option in patients with follicular lymphoma that doesn't respond to rituximab (Rituxan)". Researchers found that "in 116 patients who failed to achieve at least a partial response to rituximab -- either alone or with chemotherapy -- objective responses occurred in only 11 percent of those taking ofatumumab." Notably, "the response was higher -- 22 percent -- in a subgroup of patients who had failed rituximab monotherapy," which "opens the possibility that ofatumumab might still be helpful in a combination regimen," the researchers noted. Meanwhile, "patients who had failed rituximab in combination with chemotherapy -- either as maintenance or as part of an induction regimen -- had much worse responses."
Drug combo elicits responses in patients with relapsed, refractory mantle-cell lymphoma.
A researcher from Mayo Clinicreported, "Half of patients with relapsed or refractory mantle-cell lymphoma achieved major responses when treated with the investigational agent temsirolimus and rituximab (Rituxan), data from an ongoing clinical study showed".Responses persisted for almost 10 months and demonstrated durability in rituximab-refractory patients," according to MedPage. Ansell added, "We observed complete responses in about 20% of patients, and complete responses are uncommon after transplant failure or in patients who have received multiple regimens."
Once-daily dose of enoxaparin may be feasible for children at high risk of VTE. The study presented at the American Society of Hematology reported, "Researchers said it is feasible to provide once daily dosing of the low molecular weight heparin enoxaparin (Lovenox) to children at high risk of venous thromboembolism”.Pharmacokinetic modeling and data from 126 children -- including neonates, infants and children -- who were administered enoxaparin off-label" to perform "pharmacokinetic analyses." The lead researcher said, "According to these results...a once-daily enoxaparin dosing regimen seems to be feasible for at least 50% of this population."
Bisphosphonates may cut breast cancer risk in postmenopausal women.
A new study that shows a drug a lot of older women already take to protect against bone loss, might also help protect against breast cancer." NBC (Bazell) added, "At a major meeting of breast cancer researchers in San Antonio, the scientists today released the study of the records of 154,000 women" taking "the class of drugs called bisphosphonates, including Actonel [risedronate], Boniva [ibandronate sodium], and Fosamax [alendronate]." Retrospective analysis of data from the Women's Health Initiative" revealed that "there were 3.29 cancers per 1,000 women taking the drugs over the course of a year, compared with 4.38 cancers per 1,000 women not taking the drugs." Researchers calculated that "there were 32 percent fewer new breast cancers among users of oral bisphosphonates."
Meanwhile, a second study of 4,500 postmenopausal women who took bisphosphonates, presented at the San Antonio Breast Cancer Symposium, showed a 30 percent reduction in breast cancer risk. But, because neither trial randomized women to bisphosphonates, it remains unclear whether the drugs were actually responsible for the drop in cancer risk. Neither study collected information on side effects," even though the drugs "can cause bone, joint, or muscle pain, and in rare cases, jawbone decay." In addition, the analysis of the Women's Health Initiative data showed that "women taking bisphosphonates were more likely to develop a noninvasive tumor of the milk duct called DCIS."
The researchers "said they would urge that new studies be undertaken comparing the bone drugs with placebos to see if the drugs really do cut the risk of cancer and urged caution in judging the implications for breast cancer prevention." They said, "The findings could mean that bisphosphonates prevent invasive but not in situ breast cancer, prevent the progression of in situ cancer to invasive cancer, or something entirely different."
Also at http://www.pharm-education.com/2009/12/drug-research-updates_27.html
Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Celebrex may interfere with cardioprotective benefit of aspirin.
The pain killer celecoxib (Celebrex) may interfere with the cardioprotective benefit of low-dose aspirin, researchers found." The researchers reported online in the Proceedings of the National Academy of Sciences that celecoxib "tightly binds to one form of Cox-1 that prevents aspirin from reaching its antiplatelet target." In addition, the researchers "confirmed that celecoxib and aspirin given together did not prevent clotting to the same degree as aspirin alone in an animal model."
Cancer drug may also benefit asthma patients. A drug being tested to treat cancer could also help patients suffering from asthma." It's well understood that "too many uncontrolled eosinophils can damage other cells that line the lung, contributing to inflammatory conditions such as asthma." But, scientists at Edinburgh University discovered that the drug, R-Roscovitine, "caused the eosinophil cells to undergo a form of cell death known as apoptosis, a natural process where unwanted cells are removed from the body." The discovery, investigators say, "could lead to an alternative way to treat asthma in patients who are resistant to steroid treatments."
Herceptin during chemotherapy may boost survival in some patients with breast cancer. New research suggests that certain breast cancer patients who take the drug Herceptin [trastuzumab] during chemotherapy, instead of taking it afterward, fare better." In a study presented at the San Antonio Breast Cancer Symposium, researchers examined "outcomes for hundreds of women who underwent different treatment regimens" for "HER2-positive breast cancer." Patients "had 25 percent better disease-free survival rates at five years when trastuzumab was started concurrently with chemotherapy, rather than sequentially." But, "the trial was complicated by temporary closure of the concurrent trastuzumab arm early in the study for analysis of potentially adverse cardiac events. But, because the study showed that "the five-year survival rate increased to 84 percent among women taking the drugs concurrently versus 80 percent among those taking the drugs sequentially,the researchers concluded that concurrent use is the best way" to "decrease the risk of cancer recurrence.
Anthracyclines with Herceptin may be linked to heart damage in HER2-positive breast cancer patients.According to findings reported at the San Antonio Breast Cancer Symposium, anthracyclines, a class of chemotherapy drugs, may be linked to heart damage when used in combination with Roche Holding AG's Herceptin [trastuzumab] in women with HER2-positive breast cancer. Although the study showed that "women who got anthracyclines and Herceptin were less likely to have recurrences of their cancer and to die," researchers also found that two percent of patients receiving the combination treatment "developed heart failure, 0.7 percent died of leukemia, and 19 percent had changes in their heart function that might lead to heart failure in the future." Meanwhile, "among those who got Herceptin without anthracyclines, 0.4 percent developed heart failure and nine percent had worsened heart function." The researchers concluded that "eliminating the anthracycline from chemotherapy when using trastuzumab (Herceptin) may be just as effective long term. They noted that "a nonanthracycline based regimen with trastuzumab was not associated with significantly more breast cancer recurrences or deaths."
Herceptin plus Tykerb may improve survival in patients with HER2-positive breast cancer. According to research presented at the San Antonio Breast Cancer Symposium,a combination of two drugs that more precisely target tumors significantly extended the lives of women who had stopped responding to other treatments. The study of 300 patients showed that women receiving Herceptin [trastuzumab] and Tykerb [lapatinib] "lived 20 weeks longer than those given Tykerb alone.
Experimental drug may stop stem cell growth in patients with breast cancer.According to research reported at the San Antonio Breast Cancer Symposium, researchers "have an experimental drug that seems to stop" stem cells "in breast cancers." For the study, the researchers "first identified a vulnerable target on the breast stem cells called the Notch receptor and used an experimental drug, gamma-secretase inhibitor, along with a common anticancer drug, docetaxel -- first on mice grafted with human tumors, and later in a few women with advanced breast cancer”.Research confirms benefit of intensive approach to lipid-lowering.
Reports published in MedPage Today stated "post-hoc analyses of two landmark statin trials -- PROVE-IT and IDEAL -- affirm the value of an intensive versus moderate approach to lipid-lowering." In fact, "staying the course with intensive lipid-lowering -- in this case 80 mg atorvastatin (Lipitor) versus either 40 mg pravastatin (Pravachol) or 20-40 mg of simvastatin (Zocor) -- actually 'reduces events by about 50% over time,' Christopher Cannon, MD," said. MedPage Today added, "This is 'an even more dramatic reduction in events' than the benefit seen at the primary endpoint of 30 days.
Tamoxifen plus anthracycline-based chemotherapy may boost breast cancer survival.According to a study reported at the San Antonio Breast Cancer Symposium and online" in The Lancet, "anthracycline-based chemotherapy added to tamoxifen continues to offer a survival advantage for postmenopausal breast cancer, In a study of 1,477 patients, researchers found that "women treated with chemotherapy and then tamoxifen had a 24 percent improvement in disease-free survival, compared with women treated with tamoxifen alone." The study "also showed a trend toward better survival when the chemotherapy and tamoxifen were given sequentially rather than concurrently." Also at http://www.pharm-education.com/2009/12/drug-research-updates_26.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Boehringer to announce trial results of female desire drug. Boehringer Ingelheim GmbH "is putting the finishing touches on a pill designed to reawaken desire by blunting female inhibitions." The company has been studying the drug compound, called Flibanserin, "for more than a decade and it has yet to publish clinical test results showing the drug is effective." It is said to announce data from trials of more than 5,000 European and US women "at the European Society for Sexual Medicine conference." The main criterion for the clinical trials...was how many 'satisfying sexual events' women said they had experienced after starting treatment."
Pentamidine may combat genetic defects leading to type 1 myotonic dystrophy. University of Oregon chemist J. Andrew Berglund reported that researchers "tested the drug pentamidine in mice and found that it appears to combat genetic defects that lead to type 1 myotonic dystrophy, one of nine types of muscular dystrophy," and "also known as DM1 and Steinart's disease." Further, the levels used in mice "would be poisonous in humans," but "could be modified." Pentamidine "is approved to treat several conditions, including a severe type of pneumonia in people with compromised immune systems, some yeast infections and sleeping sickness." Fixed-dose combination of fluticasone reduces serious asthma exacerbations, costs. According to Richard H. Stanford, PharmD, director of US Health Outcomes at GlaxoSmithKline, and colleagues, "Asthmatic children treated with a fixed-dose combination of fluticasone propionate plus salmeterol [Advair] experienced fewer serious asthma exacerbations and lower costs than those treated with inhaled corticosteroids plus montelukast," Specifically, the "use of fluticasone propionate plus salmeterol was associated with a 96 percent reduced risk of having an asthma related inpatient hospital visit and a 56 percent lower risk of having an inpatient visit or an emergency department visit compared with treatment with inhaled corticosteroids and montelukast." Leukemia drug may limit growth of ovarian cancer cells. A study published in British Medical Journal reported, "A drug for people with a form of leukemia holds promise as a possible treatment for ovarian cancer". The drug, dasatinib, is currently "used to treat chronic myeloid leukemia," but researchers found that the treatment "limited the growth and invasive powers of ovarian cancer cells." Dasatinib also "proved to have even more cancer-fighting powers when it was combined with chemotherapy and used to fight certain kinds of ovarian cancer cells known as Src dependent."
Researchers noted that the findings may help "predict response to" dasatinib. Early data for ALS drug candidate shows improved muscle function. Sangamo Biosciences Inc. reported that early data from a clinical trial shows its Lou Gehrig's disease drug candidate," SB-509, "improved patients' muscle function." Patients injected with the drug "were about twice as likely to have improved muscular function," according to Sangamo. Specifically, "32 percent of patients who received SB-509 had improved muscle function, compared to 17 percent of patients who took standard treatments." The company "is also testing SB-509 as a treatment for diabetic neuropathy." Patients who take statins may not immediately require therapy for CLL. According to research presented at the American Society of Hematology meeting,patients who are taking statins to reduce cholesterol when they're diagnosed with chronic lymphocytic leukemia (CLL) may be less likely to need treatment for the cancer,". The analysis of data on 254 patients taking statins showed that "therapy for" CLL "was not immediately required in 132 (52 percent) patients." But, researchers noted that "even though patients taking a statin at the time of diagnosis were less likely to ever require therapy, statin use was not associated with a significant improvement in overall or treatment-free survival." Furthermore, "the researchers said they did not find any significant correlation between the need for treatment and total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, or triglyceride levels at diagnosis." Generic version of Alzheimer's medication receives FDA approval. Reports from the US Food and Drug Administration "has approved the first generic version of an orally disintegrating tablet containing the Alzheimer's-related dementia drug donepezil (Aricept); the approval of the application by Mutual Pharmaceutical covered 5 and 10 mg dosages."
Drug candidate to treat Peyronie's disease yields mixed results in midstage trial. Auxilium Pharmaceuticals Inc. Reported that its drug candidate Xiaflex (collagenase clostridium histolyticum) to treat Peyronie's disease , improved the condition in 29.7 percent of patients after 36 weeks, compared with 11 percent of patients taking placebo in a midstage study. Still, the company said there were no statistically significant results in the drug's effectiveness at reducing patients' pain, intercourse coonstraint and discomfort during intercourse." The company expects to meet with the FDA "during the second quarter of 2010 to discuss a proposed late-stage study." Hepatitis C drug candidate shows positive proof-of-concept results in early study.Achillion Pharmaceuticals Inc. Reported that its hepatitis C drug candidate showed positive 'proof-of-concept' results, while meeting safety and tolerability goals in an early-stage study." Achillion said the drug candidate, called ACH-1625, "reduced levels of the virus in patients taking the five-day course." The AP adds, "Enrollment in the study is still ongoing and is expected to reach 54 patients." The company also "said it expects to share additional data on the study in early January, with full data set for a presentation in April at the European Association for the Study of Liver Disease meeting in Vienna." Also at http://www.pharm-education.com/2009/12/drug-research-updates.html
Disclaimer : The information presented is for knowledge purpose only and should not be interpreted as medical advise.
Intravitreal use of corticosteroid triamcinolone may slow diabetic retinopathy progression. According to a study published in the Archives of Ophthalmology, "intravitreal use of the corticosteroid triamcinolone may slow the progression of diabetic retinopathy, but adverse effects including cataract formation and glaucoma may prevent use of this treatment merely to reduce progression of proliferative diabetic retinopathy." Two years after treating a "total of 840 eyes from 693 participants with diabetic macular edema" who were randomized "to receive laser therapy (n = 330), 1 mg of triamcinolone acetonide (n = 256), or 4 mg of triamcinolone acetonide (n = 254)," researchers found that "the cumulative probability of progression of retinopathy was 31% in the laser group, 29% in the 1-mg group, and 21% in the 4-mg group." Birth control pills may treat menstruation-related disorders, reduce risk of some cancers. A new Practice Bulletin issued by the American College of Obstetricians and Gynecologists and appearing in the J. Obstetrics & Gynecology reported that hormonal contraceptives, along with preventing pregnancy may "treat menstruation-related disorders, such as severe menstrual pain and heavy menstrual bleeding. In addition, "combined contraceptives containing both estrogen and progesterone reduce the risk of endometrial, ovarian, and colorectal cancer." Further "potential benefits include prevention of menstrual migraines, treatment of pelvic pain caused by endometriosis and treatment of bleeding because of uterine fibroids. Extended-release niacin may improve HDL quality in patients with diabetes. A study published in the journal Circulation, "treatment with extended-release niacin" may improve the "endothelial protective effects" of "HDL cholesterol in individuals with diabetes." In a study population of "10 healthy subjects" and "33 individuals with diabetes and low HDL-cholesterol levels," researchers "randomized the diabetic patients to extended-release niacin (1,500 mg/day) or placebo for three months." The investigators found that "treatment with niacin increased HDL-cholesterol levels, but more important, also improved the endothelial protective effects compared with the HDL from healthy subjects." Cardiac glycosides said to show promise in fighting colon cancer. A research study published in the Journal of Natural Products reported that a family of naturally derived heart drugs called cardiac glycosides shows promise in fighting colon cancer. According to the researchers, they found that five cardiac glycosides "tested on laboratory cultures of human colon cancer cells...proved effective, to varying degrees, at killing the cancer cells." New study seen as having "potentially significant implications" for Merck cholesterol drugs. A report from the American Heart Association meeting minutes state that , "researchers are expected to present a study with potentially significant implications for multibillion-dollar cholesterol medications" -- Merck's Vytorin (ezetimibe and simvastatin) and Zetia (ezetimibe). Drug industry "analysts are paying rapt attention to the report because two previous studies reduced sales of the drugs after indicating that they may not work any better than cholesterol drugs known as statins that are widely available as inexpensive generics." The "analysts are waiting to see whether the new study reinforces the earlier findings or, perhaps, makes matters even worse for Merck." Also at http://www.pharm-education.com/2009/12/drug-research-and-technology-updates_24.htmlDisclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
FDA says Vytorin link to cancer risk is unlikely. According to reports from the US Food and Drug Administration, it is not likely that two cholesterol medications, Vytorin (ezetimibe and simvastatin) and Zetia (ezetimibe), increase an individual's cancer risk. However, the agency said that it cannot completely rule out an association between the drugs and an increased risk of cancer. Further it states that it has examined all of the data from the" Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, which "first raised the alarm about a possible risk and showed that significantly more subjects treated with Vytorin developed and died from all types of cancer when compared with those taking placebo." The FDA report supposedly further states that it is not advising doctors or consumers to stop using any of the...medications, but will continue to evaluate the clinical benefits and potential risks of Vytorin and Zetia compared to other cholesterol-lowering drugs it has approved." Chemotherapy drugs may cross blood-brain barrier, disrupt brain cell regeneration. According to research published in the journal Cancer Investigation, four chemotherapy drugs "caused a significant breakdown in brain cell regeneration" in rodents. In fact, researchers found "a 15.4 percent reduction in new brain cells after use of fluorouracil, a 30.5% reduction following cyclophosphamide, a 22.4% reduction following doxorubicin, and a 36% reduction following paclitaxel." The researchers suggested that "all...chemo drugs cross into the brain after all, or that they act via peripheral mechanisms, such as inflammation, that could open up the blood-brain barrier." Some doctors, researchers concerned generics may not work as well as brand-name drugs. A column in the NewYork Times, Lesley Alderman wrote that "there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts." Cardiologists and neurologists in particular are concerned about variations in generic formulations that "could have a serious effect on a patient's health." But, insurers cite research that shows "no difference in hospitalizations or emergency-room visits for people on brand-name epilepsy drugs compared with those taking generics." For its part, the FDA "says it stands behind generic medications and its methods of approving them." Gary J. Buehler, director of the FDA's office of generic drugs, said the agency has "not seen any scientific studies that show generics do not hold up as well as brand name drugs." Cold capsules recalled. According to a report published in the American Press, consumer-product maker "Procter & Gamble Co. is recalling 700,000 packs of Vicks DayQuil [acetaminophen, dextromethorphan, doxylamine, pseudoephrine] capsules because they are not childproof," in spite of "labeling claims on the box" that they are. Specifically, P&G is recalling DayQuil Cold & Flu 24-Count LiquiCaps Bonus Pack. According to a P&G spokeswoman, "the product was distributed nationally between September 2008 and February 2009, and more recently between September and December this year." Small infection risk with antibiotic-free intravitreal drug injections.
According to report published in the Dec. issue of the Archives of Ophthalmology, "intravitreal drug injections led to an infection rate of less than one in 1,000 with a protocol that avoided antibiotics and sterile gloves and drape." After analyzing data on "a total of 3,838 intravitreal injections" of ranibizumab or triamcinolone "administered to 733 eyes by 124 physicians," researchers found that "only three cases of culture-positive endophthalmitis occurred following intravitreal injection." Notably, "in about a third of cases, patients received antibiotics before and after injection, but in the remaining two-thirds, patients received antibiotics before or after the procedure or not at all." Also at http://www.pharm-education.com/2009/12/quality-and-safety-updates.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
FDA approves expanded indication for Spiriva HandiHaler. "Spiriva HandiHaler [inhaled tiotropium bromide]" has been approved by the US Food and Drug Administration "as a treatment for reducing symptoms and difficulty breathing because of chronic obstructive pulmonary disease (COPD)." The new indication was based on results of two clinical trials with nearly 8,000 patients combined -- one called UPLIFT and a separate six-month study with patients in a Veterans Affairs setting. Although the UPLIFT study did not achieve its primary endpoint of showing a slowed rate of lung function decline relative to placebo, clinical data demonstrated that the addition of tiotropium to preexisting respiratory medications sustained improved lung function during four years and reduced COPD exacerbations.EU drug regulators recommend approval of Prolia. Sources from Amgen Inc. said that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of the biotechnology company's osteoporosis drug Prolia, also called denosumab." The drug is still under FDA review "as a potential treatment for postmenopausal osteoporosis and as a treatment for bone loss in breast and prostate cancer patients undergoing therapy." Researchers investigating whether oral enzymes, immunotherapy effective in celiac disease. Many efforts underway to develop new, non-dietary treatments for celiac disease," including "a gluten-free diet" and protecting "patients from occasional gluten exposure" using "oral enzymes that target gluten." Researchers have found that when gluten is "broken down into smaller fragments" by combining "enzymes from bacteria and barley," it "no longer causes inflammation in the intestines." Meanwhile, researchers are also investigating whether training "the immune system to tolerate gluten" and allowing "patients to eat a regular diet" is effective. This "category of treatment, known as immunotherapy," quells "immune response in the gut," which "is driven by...cells known as T cells." Sanofi stops tests on drugs for insomnia, atrial fibrillation. Sanofi-Aventis SA reportedly stopped tests on two medicines for insomnia and atrial fibrillation because of setbacks in development." The drugmaker "withdrew applications in Europe and the US for the insomnia pill eplivanserin because of the need for 'significant further clinical development and market access constraints,' the Paris-based company said." Meanwhile, according to Sanofi, "the idrabiotaparinux medicine for use in preventing clots in patients with atrial fibrillation is being discontinued because of 'recent therapeutic advances in the field.'" Celgene says Revlimid slowed multiple myeloma progression. Celgene Corp. Correspondent stated that data from a late-stage study show Revlimid [lenalidomide] significantly slowed the progression of multiple myeloma in patients following a type of stem cell treatment." The study included patients "who...received autologous stem cell transplants, a procedure where stem cells are removed from a person's bone marrow prior to chemotherapy, then reintroduced after chemotherapy." The drug is currently "approved as treatment for multiple myeloma patients who have received at least one prior therapy." Also at http://www.pharm-education.com/2009/12/drug-updates.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.