Tumor Lysis Syndrome News and Research

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Pronai Therapeutics reports positive results from PNT2258 Phase II study on lymphoma

ProNAi Therapeutics, Inc., a leader in developing nucleic acid therapeutics, presented safety and efficacy data from its ongoing Phase II study yesterday at the 55th Annual Meeting of the American Society for Hematology (ASH) in New Orleans, Louisiana.

11 Dec 2013

ARIAD temporarily suspends commercial distribution of Iclusig drug in US

ARIAD Pharmaceuticals, Inc. today announced that it is temporarily suspending the marketing and commercial distribution of Iclusig® (ponatinib), a treatment for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), in the United States, while it continues to negotiate updates to the U.S. prescribing information for Iclusig and implementation of a risk mitigation strategy.

31 Oct 2013

FDA grants accelerated approval for Kyprolis to treat multiple myeloma

Ligand Pharmaceuticals Incorporated today announced that its licensee, Onyx Pharmaceuticals, received accelerated approval from the U.S. Food and Drug Administration (FDA) for Kyprolis (carfilzomib) for Injection, a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

21 Jul 2012

FDA grants accelerated approval to Onyx's Kyprolis for treatment of multiple myeloma

Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Kyprolis (carfilzomib) for Injection, a proteasome inhibitor, indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

21 Jul 2012

$Celgene reports final results from REVLIMID-rituximab combination phase II study for relapsed/refractory CLL$

Celgene reports final results from REVLIMID-rituximab combination phase II study for relapsed/refractory CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, (NASDAQ: CELG), announced final results from a phase II investigational study evaluating the combination of REVLIMID® (lenalidomide) and rituximab in 59 patients with relapsed or refractory chronic lymphocytic leukemia (CLL). These data were presented at the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.

14 Dec 2011

Celgene announces interim results of REVLIMID study on CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced interim results of CLL-009, a study evaluating three starting doses of REVLIMID (lenalidomide), followed by step-wise dose escalation as tolerated in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

12 Dec 2011

Gene therapy to combat leukemia

In a medical breakthrough scientists have found that gene therapy could be used to cure leukemia. Researchers at the University of Pennsylvania engineered patients' own pathogen-fighting T-cells to target a molecule found on the surface of leukemia cells. These genetically modified T-cells were grown outside of the body and infused back into patients suffering from late-stage chronic lymphocytic leukemia (CLL), which affects the blood and bone marrow and is the most common form of leukemia.

11 Aug 2011

Gleevec shows significant overall survival benefit for patients w/ GIST after 3 years of adjuvant treatment vs. 1 year

Novartis announced new data today showing a significant improvement in both recurrence-free survival and overall survival for patients taking Gleevec® (imatinib mesylate)* tablets for three years after surgery to remove KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST) compared to one year of treatment. These data will be presented at the 47th American Society of Clinical Oncology (ASCO) plenary session on Sunday, June 5.

6 Jun 2011

3SBio acquires pegsiticase global rights from EnzymeRx for $6.25 million

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, announced that is has acquired worldwide rights of pegsiticase for all indications from EnzymeRx for a total consideration of US$6.25 million.

29 Nov 2010

Experts address fundamental questions related to renal failure in ICU

Despite the fact that recent medical advances have allowed healthcare professionals to stabilize patients who would have otherwise died, many stabilized patients later develop organ system failure. In fact, acute renal failure is one of the biggest threats to critically ill patients: forty percent of patients with this condition die.

14 May 2010

$EnzymeRx reports positive results from first clinical trial of pegsitacase for refractory gout$

EnzymeRx reports positive results from first clinical trial of pegsitacase for refractory gout

EnzymeRx, LLC, a clinical-stage biotechnology company, announced top line results from its first clinical trial of pegsitacase (formerly called Uricase‑PEG 20). Pegsitacase is a pegylated uricase being developed by EnzymeRx for the treatment of refractory gout and for the management of hyperuricemia associated with tumor lysis syndrome.

30 Apr 2010

Enzymerx completes enrollment for clinical trial of pegsitacase

EnzymeRx, LLC, a clinical-stage biotechnology company, announced completion of the enrollment of its first clinical trial of pegsitacase (formerly called Uricase-PEG 20), and the recent launch of a second clinical study. Pegsitacase is a pegylated uricase being developed by EnzymeRx for the treatment of refractory gout and for the management of hyperuricemia associated with tumor lysis syndrome.

22 Feb 2010

Rituxan, intended for patients with CLL receives FDA approval

The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

18 Feb 2010

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

Celgene International Sàrl announced that investigational data evaluating combination therapy with REVLIMID (lenalidomide) and rituximab in patients with indolent non-Hodgkin’s lymphoma (NHL) were presented during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.

9 Dec 2009

Positive data from Gloucester Pharmaceuticals' ISTODAX study presented at the ASH meeting

Gloucester Pharmaceuticals announced today the presentation of positive data from an analysis of ISTODAX® (romidepsin) in a subset of patients from Gloucester’s registration study in cutaneous T-cell lymphoma (CTCL) at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA.

7 Dec 2009

EnzymeRx commences patient enrollment in Uricase-PEG 20 phase 1 study

EnzymeRx, LLC (www.enzymerx.com), a clinical-stage biotechnology company, announced that it has launched its first clinical study of Uricase-PEG 20. Subjects have begun enrolling in a phase 1 safety, pharmacokinetic and pharmacodynamic study of single intravenous doses of Uricase-PEG 20.

2 Nov 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009

Investigational New Drug application for Uricase-PEG 20 approved

EnzymeRx, LLC, a clinical-stage biotechnology company, announced that its Investigational New Drug (IND) application for Uricase-PEG 20, filed with the U.S. Food and Drug Administration (FDA) last month, has become effective.

25 Sep 2009

Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

20 May 2009

Study of Rituxan (rituximab) in lupus nephritis misses primary endpoint

Genentech, Inc. and Biogen Idec has announced that a Phase III study of Rituxan (rituximab) plus mycophenolate mofetil (MMF) and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks.

11 Mar 2009