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Clinical Research Newsletter

  • 17th June 2019

    New Guidance on Off-Label drug benefits in trials: Health Canada
    The agency, Health Canada, issued guidance to study the off-label uses of different drugs in clinical trials.

    17th June 2019

    Pomegranate’s Anti-aging compound wins during human clinical trials
    Many diseases are caused due to aging and targeting that process can be handy in treating those diseases and improving quality of daily life. EPFL researcher’s have reported that a pomegranate derived compound shows promising signs towards achieving this goal. In human clinical trials, the fruit-derived compound showed that it can slow mitochondrial aging in elderly patients without any side effects.

    12th June 2019

    BioCell Technology Announced BioCell Collagen®
    The correlation between BioCell Collagen® effects with associated changes to skin aging were represented by BioCell Technology during the clinical trial. 128-female subjects were studied for 12 weeks with placebo to some and twice daily 500mg BioCell Collagen® orally to some. Results of placebo and BioCell Collagen® were compared in 113 participants completing the study.

    12th June 2019

    Novartis Cosentyx® showed efficacy in psoriatic arthritis manifestations
    Rheumatology and immune-dermatology leader, Novartis announced new clinical data from MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA).

    11th June 2019

    TrialAssure launches clinical trial summaries portal
    TrialAssure’s new online portal “TrialResults.com” comes as a boon when the industry faces mounting pressure to be more transparent than ever. It enables sponsors to publicly share clinical trial summaries in simple language and provide a platform for participants to access summaries in their native language.

    11th June 2019

    BCM-95 Curcugreen:Osteoarthritis treatment
    In recently issued human clinical study, Arjuna Natural Ltd.’s patented, high-potency curcumin formulation BCM-95 (Curcugreen) demonstrated the possibilities for efficiently managing Osteoarthritis symptoms. Pain is the key symptom of Osteoarthritis in which individuals seek medical care.

    05th June 2019

    US FDA draft guideline on clinical trial diversity augmentation
    Draft guidance has been released by the USFDA regarding the ways to enhance the participation of population diversity in clinical trials. Sponsors must consider the USFDA recommendations while designing and conducting clinical trials in order to eliminate avoidable exclusions and to get effective safety data.

    05th June 2019

    Roche, AbbVie become successful in Venclyxto Phase III results
    CLL trial data for Venclyxto (venetoclax) plus Gazyvaro (obinutuzumab) is shared by Roche and AbbVie in the New England Journal of Medicine. The trial was done in patients who had untreated chronic lymphocytic leukemia.

    04th June 2019

    Positive results announced by RemeGen Ltd. for RC48 clinical trial in HER2-Positive Metastatic or Unresectable urothelial cancer
    Positive results pertaining to RC48 Phase II clinical trials were announced by RemeGen Ltd. The company had evaluated a potential new medicine for patients who have HER2-positive metastatic or unresectable urothelial cancer. These patients had undergone chemotherapy treatment earlier and had visceral metastasis.

    04th June 2019

    Phase II Clinical Trial will be initiated by Vanessa Research to treat rare pediatric disease
    Turkish Ministry of Health has given approval to Vanessa Research for conducting Phase II Clinical Trial of Shylicine. It is the first-ever investigational oral solution for the treatment of lethal and rare microvillus inclusion disorder. The efficacy and safety of Shylicine will be studied during twelve-weeks of Phase II clinical trials.

    04th June 2019

    First line Cholangiocarcinoma therapy announced by Incyte
    An open-label Phase III study for FIGHT-302 using pemigatinib (INCB54828) is announced by Incyte. It is a selective fibroblast growth factor receptor inhibitor in comparison to cisplatin with gemcitabine chemotherapy, which is the current treatment for patients with surgically unresectable or metastatic cholangiocarcinoma.

    22nd May 2019

    Significant improvements observed for new inhaled treatment by Novartis during phase II data
    Novartis is developing the new combination for asthma treatment which will be given once daily. It involves the combination of indacaterol acetate /glycopyrronium bromide, which imparts bronchodilation effect along with momentasone furoate through dose controlling Breezhaler.

    15th May 2019

    First phase clinical trials cleared for novel Alzheimer’s drug
    A novel drug to treat Alzheimer’s disorder has effectively passed the first phase of clinical trials. It will be now tested on patients through Priavoid during Phase two clinical trials.

    Collaboration between US-China: Acceleration in Clinical Trials
    The approval process duration of effectively developed cancer therapies in other countries such as the United States has been reduced in China after the recent regulatory changes. This can help in bringing the lifesaving cancer treatment to patients at a much faster rate. Memorial Sloan Kettering (MSK) has collaborated with the Chinese Thoracic Oncology Group (CTONG) followed by this regulation. CTONG has more than 20 cancer centers in China, where subjects from China and the United States can enroll themselves for clinical trials. The primary goal for this collaboration is to conduct clinical trials for lung cancer, which is the major cause of death in both countries. Telemedicine is the other distinctive aspect of this collaboration. To gain policy advisory support, MSK and CTONG have taken the assistance from leaders of US FDA, China National Medical Products Administration, Australian Lung Cancer Trials Group and New York based Asia Society Policy Institute.
    Patients heartbroken after failure of Alzheimer’s clinical trials
    Biogen and Eisai were running a clinical trial for Alzheimer’s disorder. They lost billion dollars after the failure of this trial. Mind and memory of an individual in Alzheimer gets deteriorated to an extent where they are not able to perform their function. Four drugs related to Alzheimer’s disorder were approved by FDA. However, all of them were just helping systems, none of them is slowing or reversing the disease.
    New Inclusion Policy in Clinical Research: Effective way to include all Ages
    Newer challenges related with recruitment planning and study design will be set to the industries involved in clinical trials with the expansion of inclusion policy.
    Shorter regimen supported by clinical trials for multidrug-resistant TB
    A non-inferiority phase 3 trials has been done in 424 subjects having rifampin-resistant tuberculosis and are susceptible to aminoglycosides and fluoroquinolones. Random selection of subjects was done to impart either a long regimen of 20 months or short regimen of 9-11 months in line with WHO guidelines. It was concluded from the trial that short regimen was alike the long regimen in safety terms.
    A more focused trial for pancreatic cancer
    The study at University of Glasgow was initiated with the purpose to match more effective and targeted treatment with patients. University of Glasgow’s clinical trials project along with a research program by Precision-Panc had initiated the trial to bring a patient-specific pancreatic cancer treatment approach. Cancer Research UK has given the major funding for the project. The project has recently recruited 100th patient for their study which is a remarkable success.
    Phase 1 Clinical Trial initiated for APVO210
    A novel Bi-specific antibody, APVO210 developed by Aptevo Therapeutics has been developed to treat Inflammatory and Autoimmune disorders. As per the officials of the firm, the Phase 1 clinical trials for the bi-specific antibody have been initiated. The major aim of the biotechnology company, Aptevo Therapeutics Inc. is to develop novel hematology, autoimmune and oncology therapeutics.
    Draft Guideline of Bioavailability Trials by FDA
    There will be guideline update by FDA regarding how to conduct trails by clinical investigators. The update will be done to in line the approval standards with updated science and technology. As per the FDA official, they will also update the review process at each stage of innovative products.
    Upcoming of Rare cancers
    The number of common cancer types is reducing and an increase in uncommon cancer type is observed in the study conducted at National Cancer Center Hospital, Japan.
    Reports of fragmentary Clinical hold on MGD009 Phase 1 study by Macrogenics (MGNX)
    Macrogenics, Inc. is a biopharmaceutical company at the clinical stage, it is targeting for discovering and developing a monoclonal antibody-based therapeutic system for cancer treatment. This organization made an announcement on December 6th stipulating that they have received a letter from USFDA in which they have put some kind of restriction on Mono-therapy study of MGD009 Phase 1, which is a B7-H3 x CD3 bispecific DART ® molecule along with MGD009 and MGA012 (anti-PD-1) combination study.
    Draft Guidance Released by USFDA to conduct FIH clinical trials for Cancer Drug Developers
    A draft guidance to conduct first in human (FIH) clinical trials for cancer drugs has been released by USFDA which will help sponsors in designing clinical trials to speed up the development of cancer drugs through multiple expansion cohort study designs.
    Domagrozumab (PF-06252616) clinical studies evaluating the treatment of Duchenne Muscular Dystrophy terminated by Pfizer
    A Phase 2 safety and efficacy study (B5161002) and an open label extension study (B5161004) evaluating Domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy has been terminated by Pfizer. Duchenne muscular dystrophy (DMD) is a rare, serious, debilitating childhood genetic disease characterized by progressive muscle degeneration and weakness and significantly shortened life expectancy.
    Pilot Program for encouraging the complex trial designs for Drugs and Biologics launched by USFDA
    USFDA has launched a pilot program to support the use of complex innovative trial designs in the development of drugs and biologics. The launch of pilot program was decided after discussion held during a public meeting held in March although certain concerns were raised by stakeholders such as Genetech and Biogen regarding flexibility and scope of such trials.
    FDA granted Orphan Drug Designation to ASLAN003 for acute myeloid leukemia (AML) treatment
    Orphan Drug Designation has been granted to ASLAN003 which is a product of ASLAN Pharmaceuticals by USFDA for the treatment of acute myeloid leukemia (AML). ASLAN003 is an orally active potent inhibitor of human dihydroorotate dehydrogenase (DHODH) which depletes the intracellular pool of pyrimidines thereby lowering the levels of adenosine triphosphate and induction of the tumor suppressor p53 which at high levels can trigger apoptosis (programmed cell death).
    TrialAssure has joined hands with Otsuka Pharmaceuticals to provide its Clinical Trial Disclosure Reporting System
    TrialAssure is a global clinical trial disclosure and transparency reporting company which helps clients to meet regulatory compliance goals through a flexible, scalable and streamlined platform that gets regularly updated with respect to ever-changing clinical trial disclosure requirements. Otsuka Pharmaceutical Development and commercialization, Inc. is a global healthcare company based in Tokyo, Japan.