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Seattle Genetics Reports Second Quarter 2012 Financial Results

Posted: Published on August 8th, 2012

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today reported financial results for the second quarter ended June 30, 2012. The company also highlighted progress with ADCETRIS (brentuximab vedotin) commercialization activities, ongoing and planned clinical trials and upcoming milestones. As the leader in developing antibody-drug conjugate therapies, we along with our many collaborators are using our technology to change the way cancer is treated, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. We remain focused on making ADCETRIS available to patients, and we are delivering on this priority both through continued commercial initiatives for patients in the labeled indications, as well as through our robust clinical development of ADCETRIS in earlier lines of therapy and other CD30-positive malignancies. We are also focused on advancing our robust pipeline of ADC candidates and leveraging our ADC technology in collaborations to further advance the treatment of cancer. Recent ADCETRIS Highlights Other Recent Highlights Upcoming Milestones Second Quarter and First Six Months 2012 Financial Results Revenues in the second quarter of 2012 were $48.8 million, compared to $13.1 million in the second quarter of 2011. Revenues for the six month period ended June 30, 2012 were $97.1 million, compared to … Continue reading

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TiGenix Completes Patient Enrollment in Phase IIa Rheumatoid Arthritis Study

Posted: Published on August 8th, 2012

LEUVEN, BELGIUM and MADRID, SPAIN--(Marketwire -08/08/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders. "In addition to the primary endpoints of safety and optimal dosing, we expect this trial to yield a first indication of the duration of the efficacy of Cx611 in this very difficult patient population: the enrolled patients have previously failed to respond to at least two biologicals," said Eduardo Bravo, CEO of TiGenix. "In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result. This is the most advanced stem cell therapy trial in RA in the world, and completing … Continue reading

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TiGenix Completes Patient Enrollment in Phase IIa Rheumatoid Arthritis Study

Posted: Published on August 8th, 2012

LEUVEN, BELGIUM and MADRID, SPAIN--(Marketwire -08/08/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders. "In addition to the primary endpoints of safety and optimal dosing, we expect this trial to yield a first indication of the duration of the efficacy of Cx611 in this very difficult patient population: the enrolled patients have previously failed to respond to at least two biologicals," said Eduardo Bravo, CEO of TiGenix. "In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result. This is the most advanced stem cell therapy trial in RA in the world, and completing … Continue reading

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Charges filed against naturopaths for marijuana prescriptions

Posted: Published on August 8th, 2012

Dimitrios Jimmy Magiasis The state Department of Health has charged two naturopaths with unprofessional conduct for operating an assembly line practice of authorizing medical marijuana at last years Hempfest. The charges, filed Tuesday, appear to be the first disciplinary action taken against a state medical professional for a medical marijuana authorization, said Tim Church, a DOH spokesman. The two naturopaths, Carolyn Lee Bearss and Dimitrios Jimmy Magiasis were featuredin a Seattle Times storylast August in which a reporter received a medical marijuana authorization for $150 at a Hempfest tent. Bearss recommended marijuana as treatment for the reporters lower-back pain without seeing medical records after an appointment that lasted 11 minutes. The naturopaths were independent contractors for a company owned by 4Evergreen Group, one of the largest regional clinics specializing in medical marijuana authorizations. During Hempfest, the two naturopaths saw a combined 216 patients and recommended marijuana for 214 of them, according to the DOH charges againstBearssandMagiasis. The charges accuse the naturopaths of stretching the definition of intractable pain one of the qualifying conditions under the state medical cannabis law and of failing to explore other treatment options, as also required. This assembly line type of practice failed to meet the … Continue reading

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2 face medical discipline for Hempfest pot prescriptions

Posted: Published on August 8th, 2012

Two naturopaths are facing disciplinary action after a weekend of writing medical marijuana authorizations at last year's Hempfest. Carolyn Lee Bearss and Dimitrios "Jimmy" Magiasis were charged Tuesday by the state Department of Health (DOH) with running a medical marijuana "assembly line," writing authorizations at the festival without following the proper standard of care. Between them, the practitioners saw 216 patients at the three-day festival; they sent only two away without an authorization, according to the statement of charges. They are the first Washington medical providers facing disciplinary action in connection with writing marijuana authorizations, according to Tim Church, a spokesman for the DOH. Both naturopaths were working at the festival on contract for a business that owns 4Evergreen Group, a clinic with locations in Seattle and Tacoma. Eric Camm, an attorney for the practitioners, said in a statement that his clients "strongly disagree with the characterizations contained within those allegations," but declined further comment. According to a Seattle Times story written about the festival, 4Evergreen was handing out fliers at the entrance to the marijuana festival advertising authorizations for $200 or $150 for patients who had their medical records with them. Patients watched a short video about Washington's law, … Continue reading

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Hair-loss drug linked to severe depression in men

Posted: Published on August 8th, 2012

Men who take the hair-loss medication Propecia and develop sexual side effects may be at risk for severe depression and suicidal thoughts, a new study suggests. Don't miss these Health stories We've seen the colorful stripes of tape on the backs of synchronized divers, on the stomachs of beach volleyball players, the legs of track and field stars. But what is it -- and does it really do anything? In the study, 64 percent of men who developed long-lasting sexual side effects from the drug also reported experiencing moderate or severe symptoms of depression, and nearly 40 percent reported suicidal thoughts. Low libido and erectile dysfunction have been reported in men taking Propecia, and in some, the side effects persist after the medication is stopped. It is not known how many men experience long-lasting sexual side effects from Propecia, but it is thought to be a small percentage. Doctors and Propecia users should be aware of the potential serious risks of the medication, "especially as it is being used cosmetically, to alter a normal age-related process," said study researcher Dr. Michael Irwig, an assistant professor of medicine at the George Washington University School of Medicine and Health Sciences in Washington, … Continue reading

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Grapefruit juice may make low doses of anti-cancer drug as effective as higher doses

Posted: Published on August 8th, 2012

(CBS News) New research finds a simple modification may make a cancer drug three times more powerful without the side effects a higher dose would likely cause. All it takes is a glass of grapefruit juice. In the preliminary study published in the August issue of Clinical Cancer Research, scientists at the University of Chicago set out to analyze how certain foods would affect metabolism of the anti-cancer drug called sirolimus, which is an FDA-approved drug to prevent rejection of a kidney transplant and has been seen to help some people with cancer. The problem with sirolimus, however, is that the drug is easily metabolized and leaves the blood stream before it can show benefits. The optimal dose needed to show anti-tumor benefits also brings with it significant gastrointestinal problems. "Grapefruit juice, and drugs with a similar mechanism, can significantly increase blood levels of many drugs, but this has long been considered an overdose hazard," study director Dr. Ezra Cohen, a cancer specialist at the University of Chicago Medicine, said in a news release. "Instead, we wanted to see if grapefruit juice can be used in a controlled fashion to increase the availability and efficacy of sirolimus." The researchers enrolled … Continue reading

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Grapefruit juice boosts drug's anti-cancer effects

Posted: Published on August 8th, 2012

Sirolimus, a drug typically used by transplant patients to prevent rejection, has been found in previous studies to have anti-cancer properties as well. While its not currently used to treat cancer, there may be a way to give those properties a boost, and make the drug a feasible option for cancer patients by adding some grapefruit juice. A new study from the University of Chicago Medicine revealed patients taking sirolimus receive more of its anti-cancer benefits if they drink a glass of grapefruit juice every day along with the drug. The drug-juice combination was so effective that patients who drank grapefruit juice obtained three times as many benefits than those who took the drug alone. This is also interesting because of grapefruits dangerous interaction with some prescription medications, namely ones that treat high blood pressure and heart conditions. Researchers had discovered sirolimus potential anti-cancer properties from previous research. Its a drug that was discovered in the 70s, Dr. Ezra Cohen, a cancer specialist at the University of Chicago Medicine and the studys lead author, told FoxNews.com. It was clearly shown to have anti-cancer effects and anti-neoplastic effects, but it hadnt been developed for cancer extensively because the patent ran out. … Continue reading

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Lower risk of serious side-effects in trials of new targeted drugs, study suggests

Posted: Published on August 8th, 2012

ScienceDaily (Aug. 7, 2012) Patients in early clinical trials of new-style targeted cancer therapies appear to have a much lower risk of the most serious side-effects than with traditional chemotherapy, according to a new analysis. Researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust analysed data from 36 Phase I trials run by the organisations' joint Drug Development Unit. The study, published August 7 in August's Annals of Oncology, found the overall risk to patients of suffering a life-threatening side-effect was around seven times less than for traditional cytotoxic agents*. Most new cancer drugs developed over recent years are targeted agents, which attack the specific genetic or molecular faults driving cancer growth, rather than one-size-fits-all chemotherapeutics, which kill all rapidly dividing cells. Recent studies have shown that patient response rates in Phase I trials of new-generation targeted drugs are approximately two-fold higher than for old-style drugs. But until now, the risk of side-effects to patients taking part in early stage trials of new-style drugs has been unclear. Senior author Dr Rhoda Molife, a medical oncologist and senior investigator in Phase I clinical trials in the Drug Development Unit of The Institute of Cancer Research … Continue reading

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Hair-Loss Drug Tied to Depression

Posted: Published on August 8th, 2012

Young men who took Propecia for hair loss and experienced its sexual side effects also had high rates of depressive symptoms, even after stopping the drug, a retrospective study found. Among a group of men who developed persistent sexual dysfunction that continued for at least three months after they stopped taking Propecia, 75 percent reported symptoms of depression compared with 10 percent of controls who never took the drug, according to Dr. Michael Irwig of George Washington University in Washington, D.C. The symptoms were moderate-to-severe in 64 percent of the former Propecia users and in none of the controls, Irwig reported online in the Journal of Clinical Psychiatry. Read this story on http://www.medpagetoday.com. Propecia has been a popular treatment for male-pattern baldness, and sexual side effects identified during clinical trials appeared to resolve on withdrawal of the treatment. However, emerging evidence has shown that in some men the adverse effects persist, and the FDA recently amended the drug's labeling to reflect greater concern about these problems. Recent uncontrolled studies also have suggested a possible link between the drug, a 5-alpha-reductase inhibitor, and depression. To clarify this possibility, Irwig recruited a cohort of 61 men in whom sexual adverse effects persisted … Continue reading

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