Mucositis News and Research

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Soligenix initiates orBec Phase 2 study for GI manifestations of chronic GVHD

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating orBec (oral beclomethasone 17,21-dipropionate or BDP) as a treatment for the gastrointestinal manifestations of chronic Graft-versus-Host disease.

2 Dec 2013

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's: Committee for Medicinal Products for Human Use has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.

25 Nov 2013

New England publishes results of phase III clinical trial of ABRAXANE for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation , today announced the results of the MPACT phase III clinical trial of ABRAXANE® in combination with gemcitabine were published online in the October 16th edition of the New England Journal of Medicine.

17 Oct 2013

Use of feeding tubes in OPC cancer patients treated with IMPT decreased by 50%

A new study from researchers at The University of Texas MD Anderson Proton Therapy Center found that the use of feeding tubes in oropharyngeal carcinoma cancer patients treated with intensity modulated proton therapy decreased by more than 50 percent compared to patients treated with intensity modulated radiation therapy.

26 Sep 2013

Soligenix awarded $6.4M contract to advance preclinical development of OrbeShield for GI ARS

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense medical countermeasures where there remains an unmet medical need, announced today that it has been awarded a contract valued at up to $6.4 million by the US Department of Health and Human Service's National Institutes of Health (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID).

25 Sep 2013

FDA grants orphan drug designation to Soligenix’s SGX94 for treatment of Acute Radiation Syndrome

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient SGX94 for the treatment of acute radiation syndrome (ARS).

16 Sep 2013

European Commission approves Stivarga tablets for treatment of patients with mCRC

Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the European Commission has approved Stivarga® (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC).

30 Aug 2013

Spectrum Pharmaceuticals enters into agreement to acquire Talon Therapeutics

Spectrum Pharmaceuticals, Inc., a biotechnology company with fully-integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that, through a wholly-owned subsidiary, the company entered into an agreement to acquire Talon Therapeutics, Inc., a biopharmaceutical company based in South San Francisco, California, and expects to complete the acquisition within one day.

17 Jul 2013

Soligenix announces personalized medicine collaboration with SciClone

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced a personalized medicine collaboration with SciClone Pharmaceuticals in the Company's oral mucositis clinical program with SGX942.

8 Jul 2013

First clinical study for development of SGX203 to treat pediatric Crohn's disease

Soligenix, Inc. (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has enrolled and treated all patients in the Phase 1 Study BDP-PCD-01; the first clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease.

1 Jul 2013

Soligenix receives FDA Fast Track designation for SGX942 to treat patients with oral mucositis

Soligenix, Inc., a clinical stage biopharmaceutical company, announced today that its SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients has received "Fast Track" designation from the US Food and Drug Administration.

3 Jun 2013

EADV spring symposium: Bioalliance Pharma presents Sitavig study results

BioAlliance Pharma SA, a Company dedicated to the development of orphan oncology products and supportive care products, has presented the results of the pharmacokinetic and pharmacodynamic study on Sitavig at the 10th EADV spring symposium (European Academy of Dermatology and Venereology) in Cracow (Poland) on May 24, 2013.

28 May 2013

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.

23 May 2013

Bayer HealthCare to present new data on oncology portfolio at ASCO meeting

Bayer HealthCare announced today that new data on the oncology portfolio, including Nexavar (sorafenib) tablets, Stivarga (regorafenib) tablets and the recently U.S. Food and Drug Administration approved product Xofigo (radium Ra 223 dichloride) injection will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology, May 31 – June 4, in Chicago, IL (USA).

16 May 2013

Soligenix starts first clinical study for development of SGX203 for pediatric Crohn's disease

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has initiated the first clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease.

15 May 2013

Bayer HealthCare: Patient enrollment underway in Phase III trial of Stivarga tablets for treatment of HCC

Bayer HealthCare announced today that patient enrollment is underway for RESORCE (Regorafenib after Sorafenib in Patients with Hepatocellular Carcinoma), an international Phase III trial to evaluate the efficacy and safety of Stivarga (regorafenib) tablets for the treatment of patients with hepatocellular carcinoma who have progressed on Nexavar (sorafenib) tablets, an anticancer medicine for the treatment of patients with unresectable HCC.

15 May 2013

Study: Image-guided brachytherapy prevents growth of cervical tumour in over 90% of patients

Two large, landmark radiotherapy studies have shown that it is possible to treat cervical cancer effectively with high doses specifically adapted to each tumour, and with fewer serious side-effects to the surrounding normal organs.

22 Apr 2013

BIND Therapeutics presents positive Phase 1 clinical study results for BIND-014 at AACR meeting

BIND Therapeutics, a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called AccurinsTM, announced today that positive Phase 1 clinical data for BIND-014, the company's lead drug candidate, were presented today in an oral presentation at the American Association for Cancer Research 2013 Annual Meeting.

10 Apr 2013

FDA clears Soligenix's IND application for SGX942 for treatment of oral mucositis

Soligenix, Inc., a clinical stage biopharmaceutical company, announced today that the Food and Drug Administration has completed its review and cleared the Investigational New Drug application for SGX942 for the treatment of oral mucositis resulting from radiation and/or chemotherapy treatment in head and neck cancer patients.

27 Mar 2013

Smad7 protein protects against or heals mouth sores associated with cancer treatment

Mouse model studies show that administered genetically or topically, protein Smad7 protects against or heals mouth sores commonly associated with cancer treatment.

13 Mar 2013