Biotechnology & Medical Research

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Medicinova announces an open investigational new drug (IND) Application for MN-001 in NASH

8:00am EST

Medicinova Inc:Says IND(Investigational New Drug) Application for MN-001 (tipelukast) for the treatment of NASH (nonalcoholic steatohepatitis) has been accepted and is now open with the FDA (U.S. Food and Drug Administration.Importantly, due to safety data from previous clinical studies of MN-001, FDA has agreed that MediciNova may proceed with a Phase 2 study as the first clinical study of MN-001 in NASH.

CymaBay Therapeutics announces preclinical data demonstrating the potential of MBX-8025 to Treat Homozygous Familial Hypercholesterolemia

8:00am EST

CymaBay Therapeutics Inc:Says results from a preclinical study indicating the potential for MBX-8025 to decrease low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).MBX-8025 is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that, in previous clinical studies, has been shown to reduce LDL-C in patients with mixed dyslipidemia.CymaBay believes that MBX-8025 has the potential to markedly improve the lipid profile of patients with various forms of dyslipidemia, including HoFH.

Serendex Pharmaceuticals A/S receives positive scientific advice from EMA

7:40am EST

Serendex Pharmaceuticals A/S:Receives positive scientific advice from European Medicines Agency (EMA) on pre-clinical and clinical development of granulocyte macrophage colony stimulating factor (GM-CSF), molgramostim, for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).Says will continue the toxicology program for GM-CSF in accordance with guidance, and progress into a Phase I clinical trial for GM-CSF in-line with expectations.

Gynecologic Oncology Group (GOG) Phase 2 Study of Advaxis Inc's Lm-LLO Immunotherapy, ADXS-HPV, for treatment of persistent or recurrent cervical cancer achieves safety and efficacy criteria

7:30am EST

Advaxis Inc:Says an update related to Phase 2 open-label clinical study of ADXS-HPV (ADXS11-001) in patients with persistent or recurrent cervical cancer with documented disease progression being conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology.Says study, known as GOG 0265, has completed its first stage and has met predetermined safety and efficacy criteria required to proceed into the second stage of patient enrollment.This trial is being conducted in U.S. by GOG, under sponsorship of Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).GOG 0265 is an open-label, single arm 2-stage study designed to evaluate the safety, tolerability and efficacy of ADXS-HPV in about 67 patients.Patients receive one cycle (three doses) of ADXS-HPV at 1 x 10(9)cfu every 28 days.Says primary efficacy endpoint is 12-month survival, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response.Says primary safety endpoints are number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.Stage 1 enrolled 29 patients and stage 2 is set to enroll another 38.Further information about GOG 0265 can be found on ClinicalTrials.gov, using Identifier NCT01266460.

Senhwa Biosciences gets approval to begin second phase human clinical trial of CX-4945

Tuesday, 27 Jan 2015 08:21pm EST

Senhwa Biosciences Inc:Got approval from Ministry of Food and Drug Safety, MFDS to begin the second phase human clinical trial of CX-4945, which is a drug used for treatment of Cholangiocarcinoma.

Immunicum to be granted patent in Europe for production of therapeutic cancer vaccines

Tuesday, 27 Jan 2015 09:10am EST

Immunicum AB:Says patent for the production of Immunicum's therapeutic cancer vaccines to be granted in Europe.European Patent Office announced intention to grant a patent pertaining to production method of company's therapeutic cancer vaccines.

Viralytics Ltd commences clinical trial of CAVATAK in Bladder Cancer

Monday, 26 Jan 2015 09:00pm EST

Viralytics Ltd:Says that it has initiated its Phase 1 clinical trial of CAVATAK in patients with non-muscle invasive bladder cancer (NMIBC), also known as superficial bladder cancer.

Progen Pharmaceuticals Ltd updates on PI-88 clinical trial

Monday, 26 Jan 2015 06:00pm EST

Progen Pharmaceuticals Ltd:Says on Jan. 26, 2015, the Medigen Board of Directors resolved to bring forward the analysis of PI-88 Phase III PATRON clinical trial data, and will inform the Taiwan Food and Drug Administration (“TFDA”) of this decision.As of Jan. 26, 2015, all 520 patients in the PATRON trial have completed treatment with either PI-88 or the placebo.The PATRON clinical trial is a Phase III randomised, placebocontrolled trial being conducted in Taiwan, South Korea, China and Hong Kong to confirm the safety and efficacy of PI-88 in the adjuvant treatment of hepatocellular carcinoma after surgical resection.Pursuant to the clinical trial design, patients were to be treated for 12 months with either PI-88 or the placebo and receive follow-up for two years.Following this decision by the Medigen Board, other than patients receiving antiviral therapy, the patients will not receive any further follow-up beyond a final study visit to be conducted within the next 28 days.Medigen will now execute a study conclusion plan for the PATRON trial with the clinical trial sites and investigators.After the collection of the clinical data, a comprehensive statistical analysis will be carried out and a final clinical study report prepared.The final clinical study report will be submitted to TFDA after the completion of data collection and analysis.

Heat Biologics Inc presents positive immunological data on HS-410 in non-muscle invasive bladder cancer at the 7th Annual Phacilitate Immunotherapy Forum 2015

Monday, 26 Jan 2015 08:00am EST

Heat Biologics Inc:Announces positive data demonstrating substantially increased tumor infiltrating lymphocytes following treatment in its Phase 1 clinical trial of HS-410 in non-muscle invasive bladder cancer (NMIBC).Biopsies were collected at baseline and at the appearance of suspicious lesions from all patients enrolled in the Phase 1 trial.Analysis of tumor-infiltrating lymphocytes in one patient after surgery and induction BCG followed by 6 weeks of HS-410 demonstrated an about 70-fold increase in CD8 expression within the tumor, which was not associated with any increase in CD4 expression.

Insys Therapeutics receives FDA orphan drug designation for Liposomal Encapsulated Paclitaxel for the Treatment of Ovarian Cancer

Monday, 26 Jan 2015 08:00am EST

Insys Therapeutics Inc:Says U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer.

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