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toxicity in Medical Technology

Pixantrone in Combination with Chemotherapy Regimens Produces Overall Response Rates of 58-74% with Complete Remission Rates of 37-57% in Relapsed/Refractory Aggressive or Indolent NHL

... reported, neutropenia was the dose limiting toxicity when used as a single agent. "In both ... studies pixantrone exhibited lower cardiac toxicity and better anti-tumor activity than that observed ... as it is devoid of the putative cardiac toxicity generating chemical structure," said Barry W. ...

Medarex Announces Preclinical Data from Multiple Research Programs Demonstrating Anti-Tumor Activity in Cancer

... MDX-1110 showed a favorable safety and toxicity profile. MDX-1110 also demonstrated potent ... treatment for liver cancer. Efficacy and toxicity of anti-mesothelin antibody drug conjugate ... a cleavable linker also showed a more favorable toxicity and safety profile over conjugates using a ...

Novagali Pharma Presents Results of its Innovative Latanoprost Formulation for Glaucoma

... of prostaglandin analogues: an in vivo toxicity assay" at the 9th Scientific Meeting of ... studies confirmed the ocular surface toxicity of anti-glaucomatous eye drops containing ... importance taken into account that BAK exerts toxicity after long term use and that glaucoma is a ...

Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer

... breast cancer, but concerns about cardiac toxicity have prevented oncologists from using them ... continued until an unacceptable treatment-related toxicity or disease progression occurred. The ... of total cumulative dose - Cardiac toxicity may also occur at lower cumulative doses (400 ...

BioNumerik Pharmaceuticals Observes Evidence of a Survival Increase in Lung Cancer Patients Participating in Tavocept(TM) Clinical Trial

... reduction in chemotherapy-induced renal (kidney) toxicity and nausea/vomiting was also observed in ... in the Tavocept group with no dose limiting toxicity observed for Tavocept in either trial. These ... without any substantial dose-limiting toxicity of its own. Based on these results, we are ...

Poniard Announces Positive Efficacy and Safety Data From Phase 1 Trial of Picoplatin in Multiple Tumor Types Including Ovarian Cancer

... signals of clinical activity and acceptable toxicity with this combination. Picoplatin, the ... both agents could be combined with an acceptable toxicity profile," said Don S. Dizon, M.D., assistant ... cancer). Hematologic and non-hematologic toxicity were mild. This study suggests that picoplatin ...

Poniard Announces Positive Preliminary Efficacy and Safety Data From Ongoing Phase 2 Trial of Picoplatin in First-Line Treatment of Colorectal Cancer

... cycles of picoplatin therapy. The dose limiting toxicity (DLT) for the every-four-week regimen at ... in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with ...

Two DOXIL(R) Studies to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

... was accepted for publication: -- Activity and toxicity of Pegylated Liposomal Doxorubicin in ... of total cumulative dose -- Cardiac toxicity may also occur at lower cumulative doses ... -- In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute ...

Ardea Announces Progress with HIV Non-Nucleoside Reverse Transcriptase Inhibitor Program

... Candidate, RDEA806, Demonstrated No Reproductive toxicity in Preclinical Study - ... causative agent of AIDS. Animal reproductive toxicity studies recently completed with RDEA806 have ... other HIV antiviral drugs. RDEA806 reproductive toxicity data indicates that future studies, including ...

Poniard Pharmaceuticals Completes Enrollment of Phase 2 Picoplatin Trial in Colorectal Cancer

... in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with ... and demonstrated that picoplatin has a manageable toxicity in combination with 5-fluorouracil and ...

Twelve DOXIL(R) Clinical Studies to be Presented at American Society of Hematology Annual Meeting

... Lymphoma: Clinical Efficacy without Cardiac toxicity - Myron S. Czuczman, Roswell Park Cancer ... of total cumulative dose -- Cardiac toxicity may also occur at lower cumulative doses (400 ... -- In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute ...

Phase 1 & 2 Data of Perifosine (KRX-0401) in Patients with Advanced Renal Cell Carcinoma Presented Today at the 25th Annual Chemotherapy Foundation Symposium

... Showing No Evidence of Increased toxicity When Combined with Sorafenib NEW YORK, Nov. 9 ... time to progression in both parts of the study. toxicity Both, the 50 mg and 100 mg dose have been well ... daily dose of 50 mg or 100 mg with no GI toxicity was as follows: % with NO ...

Studies Suggest Key Correlation Between Lung Cancer Subtype and Treatment Outcomes

... Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy. Contraindication ALIMTA is ... folic acid and vitamin B12 died of drug-related toxicity following administration of ALIMTA alone. ALIMTA ... hematologic counts or maximum nonhematologic toxicity from the preceding cycle of therapy. Modify or ...

Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer

... NSCLC, while providing a more favorable toxicity profile and greater convenience. We look forward ... folic acid (350 to 1000 micrograms) to reduce toxicity (for full details see Summary of Product ... Dosage reduction is based upon the amount of toxicity experienced by the patient. Patients receiving ...

ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer

... to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent ... to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent ... as drug metabolism and bioavailability, excessive toxicity and treatment resistance. More information can be ...

Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

... to date suggest that hematologic events are common but manageable. Kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) are less frequent and less severe than is commonly ...

USC Keck School of Medicine's Dr. Alan Epstein Receives Prestigious National Cancer Institute RAID Award for Breakthrough IL-2 Molecule Therapeutic

... patients, the application of IL-2 is severely limited by its significant toxicity and resulting side effects, especially that of capillary leak syndrome ... Los Angeles-based biotechnology company developing innovative low toxicity therapies for cancer, has licensed the molecule from USC . The ...

Paclitaxel Poliglumex (OPAXIO(TM)) Added to Cisplatin and Radiation Produces 45% Pathologic Complete Remissions in Patients With Esophageal Cancer

... of the cancer in the surgical specimen) and a high incidence of Grade 3-4 toxicity to the upper gastrointestinal track necessitating prophylactic insertion ... response. A prophylactic feeding tube was not routinely used. Grade 3-4 toxicity in the first 15 patients included dehydration (n=5), loss of appetite ...

Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain

... upper GI symptoms (e.g., dyspepsia, heartburn). Serious NSAID-induced GI toxicity causes an estimated 16,500 deaths and more than 107,000 hospitalizations ... are reduced, NSAIDs often cause ulcers in the stomach. NSAID-induced GI toxicity causes an estimated 16,500 deaths and more than 107,000 hospitalizations ...

Study Showed Lilly's GEMZAR(R) (gemcitabine HCl for injection) Improved Progression-Free Survival in Cervical Cancer Patients

... marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, ...

Poniard Pharmaceuticals Announces Progression-Free Survival Data From Phase 2 Clinical Trial of Picoplatin in Metastatic Colorectal Cancer

... results suggest that hematologic events are severe but manageable. Kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) are less severe than is commonly observed with other ...

Poniard Pharmaceuticals Reports First Quarter 2009 Financial Results and Provides a Corporate Update

... date suggest manageable hematologic adverse events with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy ...

Poniard Pharmaceuticals to Present New Data from Phase 2 Clinical Trials of Picoplatin in Multiple Tumor Types at the 45th Annual Meeting of the American Society of Clinical Oncology

... date suggest manageable hematologic adverse events with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy ...

Poniard Completes Patient Enrollment Target in Phase 3 SPEAR Trial of Picoplatin in Small Cell Lung Cancer

... date suggest manageable hematologic adverse events with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy ...

YM BIOSCIENCES ANNOUNCES NIMOTUZUMAB PRESENTATIONS TO BE MADE AT THE 100TH ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH AND EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY

... status of patients, are in sharp contrast to the dated speculation that toxicity is a marker for efficacy of EGFR-targeting agents," said David Allan, ... at other nimotuzumab developers worldwide aimed at explaining the benign toxicity profile of nimotuzumab given its established anti-tumour activity," said ...

American Oriental Bioengineering to Initiate a Phase One Clinical Trial in the United States of AOBO-001 Oral Capsule

... AOBO-001 on UI has been evaluated in various in vitro and in vivo models. toxicity of this product was assessed through a series of toxicity studies under the conditions of GLP (Good Laboratory Practices) in China. ...

Immunomedics Announces Preclinical Therapy Results of SN-38 Immunoconjugate for Colorectal Cancer

... FDA for the treatment of colorectal, lung, and other cancers. Due to its toxicity and poor solubility, SN-38 cannot be administered systemically to cancer ... with labetuzumab-SN-38 should enhance the bioavailability and reduce the toxicity of the clinically validated drug, irinotecan , " commented Cynthia L. ...

Raptor Pharmaceuticals Corp. Announces Positive Phase IIa Clinical Study Results for Convivia(TM) Program

... other indications, but is investigational for treatment of acetaldehyde toxicity associated with ethanol exposure in ALDH2 deficient subjects. (Logo: ... of 4-MP as a potential treatment of symptoms resulting from acetaldehyde toxicity in ALDH2 deficient subjects who drink alcohol. The trial also sought to ...

Zevalin(R) Following Short-Course Chemotherapy with CHOP + Rituximab (CHOP-R) Doubles Complete Remission Rate in First-Line Treatment of Follicular Non- Hodgkin's Lymphoma

... 3 to 4 thrombocytopenia occurred in 3 (5%) patients. The most frequent toxicity associated with Zevalin was myelosuppression. Grade 3 to 4 neutropenia ... associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin ...

Poniard Pharmaceuticals Announces Final Top-Line Results from Phase 1 Trial Demonstrating Positive Bioavailability with Oral Picoplatin

... anti-tumor activity in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy ...

PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger Protexia(R)

... which has been shown to be effective in animal models in preventing toxicity from exposure to chemical nerve agents. The randomized, ... includes manufacturing process development, preclinical safety and toxicity testing, submission of an Investigational New Drug (IND) Application with ...

Landmark Study Demonstrates Potential of Radioimmunotherapy for Treatment of Indolent B-Cell Non-Hodgkin's Lymphoma

... median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with Zevalin's use in approved ... associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin ...

Algeta Reports Positive Headline Phase II Data on Pain Palliation With Alpharadin

... for a drug in this clinical setting, no significant bone marrow toxicity was observed. In men with HRPC life expectancy can be as short as 18 ... Importantly for a drug in this clinical setting no significant bone marrow toxicity was observed in patients receiving Alpharadin. The full results of the ...

Precise Low-Dose Drug Monitoring Essential for Long-Term Kidney Transplant Success

... from long-term effects of renal disease. Therefore, minimizing drug toxicity over time is considered one way to help improve long-term graft survival ... preserve quality of life for transplant patients. To minimize long-term toxicity of transplant medications, physicians frequently aim to taper down doses ...

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

... median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with Zevalin's use in approved ... associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin ...

Hope for Progeria - Successfully Validated on Mice, a Treatment Could Soon be Tested on Children

... to the accumulation in the cells of a truncated protein, progerin, whose toxicity is linked to the presence of a fatty acid which remains fixed to the ... it is eliminated in normal cells). In order to inhibit or block the toxicity of progerin, the researchers explored the path of synthesis of this ...

New Data Demonstrates 5-FU Personalized Chemotherapy Management (PCM(R)) Assay Provides Similar Performance to More Complicated Liquid Chromatography-Mass Spectrometry (LC-MS/MS)

... simplified, personalized dose management with the goal of minimizing toxicity and maximizing the therapeutic benefit of 5-FU treatment," said Salvatore ... to achieve optimal levels of 5-FU can improve response rates and minimize toxicity when compared to standard-of-care dosing based on height and weight (known ...

Keryx Biopharmaceuticals, Inc. Announces Phase 2 Results on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Waldenstroms Macroglobulinemia at the 44th Annual Meeting of the American Society of Clinical Oncology

... that single agent perifosine showed encouraging activity with manageable toxicity in patients with relapsed/refractory Waldenstroms macroglobulinemia. An ... patients with advanced Waldenstrom's macroglobulinemia, and the manageable toxicity profile seen to date. Michael Weiss, CEO of Keryx Biopharmaceuticals, ...

Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients

... also exceeded 40 percent. The study also demonstrated that the toxicity profile of clofarabine was predictable and manageable. Drug-related ... the kidneys. Concomitant use of medications known to induce hepatic toxicity should be avoided. Cardiac disorders, including tachycardia, pericardial ...

Poniard Announces Positive First-Line Efficacy and Safety Data From Ongoing Phase 2 Trial of Picoplatin in Patients with Metastatic Hormone Refractory Prostate Cancer

... anti-tumor activity in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy ...
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