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Clinical Research Newsletter

01st August 2019

Positive results reported from Udenafil Phase III FUEL Trial by Mezzion Pharma to treat adolescents with SVHD who have undergone Fontan procedure
Mezzion Pharma Co, a well-known biotech company announced the positive results from phase 3 FUEL trial. It was designed to access the safety and efficacy of udenafil for treating certain adolescents with congenital single ventricle heart disease (SVHD).

30th July 2019

Novartis Phase III PARAGON-HR study failure of sacubitril/valsartan versus active comparator valsartan in HFpEF patients
Novartis announced the global phase III PARAGON-HF study results; examining the safety and efficacy of sacubitril/valsartan versus the active comparator valsartan in HFpEF patients. The trial merely missed statistical significance for its composite primary endpoint for death reduction due to cardiovascular (CV) issues and total heart failure hospitalizations. Safety and tolerability were constant with earlier reported sacubitril/valsartan data.

24th July 2019

Experimental novel rheumatoid arthritis drug successful in final Phase of Clinical Trials
A novel experimental drug is demonstrating encouraging results through its final phase of human clinical trials. Filgotinib is a JAK inhibitor selectively targeting the JAK1 enzyme. It is chiefly being investigated for the rheumatoid arthritis treatment, but initial clinical trials have encouraged for treatment of ulcerative colitis and Crohn's disease.

22nd July 2019

Pain reduction in brain due to antidepressant SNRI medications
New research suggested that a network of brain associated with experiencing pain could be a significant target for antidepressant medications. The Trial study, published in The Lancet Psychiatry, revealed that the use of serotonin and norepinephrine reuptake inhibitors (SNRIs) led to alterations in functional architecture of the pain network of brain.

16th July 2019

New clinical trial regulations appreciated by experts
The New Drugs and Clinical Trial Rules 2019 have been lauded by the regulatory experts. The new regulations have laid the pathway to patient-science-centric human studies bringing in clarity, transparency, time predictability and harmonized it as per the ICH guidelines.

16th July 2019

Janssen’s mosaic-based HIV-1 preventive vaccine to undergo trial
Phase Ⅲ trials will be initiated by Janssen Vaccines & Prevention, a Johnson & Johnson unit, along with the partners to evaluate an investigational preventive vaccine for HIV-1 infection.

15th July 2019

Early gastric cancer diagnosis using AI
For the early identification of gastric cancer, the scientists at Okayama University have developed an artificial intelligence (AI)-based endoscopic diagnosis system.

12th July 2019

Alzheimer’s prevention clinical trials ended by Novartis, Amgen and Banner
Novartis, Amgen and Banner Alzheimer’s Institute has announced that they are stopping two pivotal Phase Ⅱ/Ⅲ clinical trials in the Alzheimer’s Prevention Initiative Generation Program.

11th July 2019

Study published about Scion’s TNM™ device
The Scion announced that results from a randomized, controlled trial of Parkinson’s disease (PD) subjects who used company’s non-invasive neuromodulation device TNM™ has been published.

08th July 2019

Safety demonstration of sustained Niagen Supplementation and optimal dosing levels by Nicotinamide Riboside study
The largest trial of nicotinamide riboside was published validating the efficacy and safety of Chroma Dex’s proprietary form of NR, Niagen. This is first clinical trial study measuring both kinetics and dose-dependent effects of chronic Niagen supplementation.

08th July 2019

Triplet therapy of Pierre Fabre plays significant part in BRAF V600E-mutant metastatic colorectal Cancer
Pierre Fabre revealed the data of phase 3 trial known as BEACON. This study used encorfenib (BRAF inhibitor), binimetinib (MEK inhibitor) and cetuximab (anti-EGFR antibody) for the treatment of BRAF V600E-mutant metastatic colorectal cancer (mCRC), in subjects who have already received one or two line of therapy as per the inclusion criteria of the study protocol.

08th July 2019

Multicenter, single arm, phase-2 study for combination of Obinutuzumab and Lenalidomide for relapsed or refractory follicular B-cell Lymphoma (GALEN)
The combination of Lenalidomide and Rituximab is successful and administered to treat patients with relapsed or refractory follicular lymphoma. Obinutuzumab has demonstrated to increase antibody-dependent cellular cytotoxicity, phagocytosis, and B-cell direct killing better than rituximab. The objective of the study was to determine the activity and safety of lenalidomide plus obinutuzumab in previously treated patients with relapsed or refractory follicular lymphoma.

03rd July 2019

Boston Biomedical announced discontinuation of Phase3 CanStemIIIP study of Napabucasin for treatment of metastatic Pancreatic Cancer due to futility
An announcement was made from Boston Biomedical Inc., regarding CanStemIIIP study for accessing the safety and efficacy of an investigational agent. Napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine study in patients with metastatic pancreatic ductal adenocarcinoma will be stopped due to futility.

03rd July 2019

Genentech’s Phase III trial successful for comparable efficacy between Xofluza and Tamiflu
Reports emerged that Genentech, a Roche company reached primary endpoint of its Phase III clinical trial called MINISTONE-2, demonstrating that Xofluza (balaxavir marboxil) was comparable to Tamiflu (oseltamivir). Tamiflu has been prevalent in the market from last two decades. Xofluza is broadly approved in the markets of Japan for people older than 12 years. The objective of the company behind this trial is to market Xofluza as an alternative to Tamiflu.

03rd July 2019

Sponsors urged by European regulators to publish Clinical trial results
The top European regulatory bodies like European Medicines Agency (EMA), European Commission (EC) and Heads of Medicines Agencies (HMA) released a letter to clinical trial sponsors last month. This step was taken to remind them to publish the results of all clinical trials conducted in the EU in EudraCT database.

02nd July 2019

Positive Results demonstrating Improvement in Disability and Quality of Life through Fremanezumab Phase IIIb FOCUS study
Teva Pharmaceutical Industries Ltd. announced the FOCUS (Phase IIIb Study of Fremanezumab) exploratory endpoints results at the 5th Congress of the European Academy of Neurology.

01st July 2019

Marketing Authorization Application submitted by Alnylam for Givosiran to European Medicines Agency for Acute Hepatic Porphyria treatment
The leading therapeutic company known as Alnylum Pharmaceuticals, Inc., announced the marketing authorization application submission to European Medicines Agency for Givosiran. Givosirn is an investigational RNAi therapeutic drug which targets Aminolevulinic Acid Synthase 1 (ALAS1) in development for acute hepatic porphyria treatment. Givosiran is administered subcutaneously.

28th June 2019

Phase 3 Revatio (Sildenafil Citrate) trial results announced by Pfizer
When the pulmonary arteries become narrower or obstructed, then the condition is known as Pulmonary Hypertension. Due to this condition, right ventricle of the heart is in lot of pressure to work hardly to pump blood leading to weakening and organ enlargement. When it is present in newborn babies, it is called as Persistent Pulmonary Hypertension of Newborn or neonatal pulmonary hypertension.

25th June 2019

Frozen embryo transfers fail to deliver any improvement during IVF process
Reports emerged from the large-scale European trial showed that the frozen embryo transfers fail to boost in vitro fertilization (IVF) process over the fresh transfers.

24th June 2019

E8(R1) Draft Guideline: ICH
In May 2019, the ICH E8(R1) draft guideline on General Considerations for Clinical Trials reached Step 2b of the ICH process and entered the period of public consultation. ICH E8’s modernization is the first step towards the GCP Renovation initiated in 2017.

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.

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