|Teva to Present New Findings at the AHS; PAREXEL Launches Next Generation Data-Driven MyTrials® Solution|
|By Josh Gee|
|Thursday, 18 June 2015 21:11|
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 18, 2015.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) announced new data from additional analyses of its phase 2b studies in migraine prevention on efficacy and speed of onset of two distinct doses of TEV-48125, a novel monoclonal anti-CGRP antibody administered subcutaneously once monthly for the preventive treatment of high frequency episodic migraine (characterized by 8-14 days of headache per month) and chronic migraine (headaches on at least 15 days per month).
The data is to be presented at the 57th Annual Scientific Meeting of the American Headache Society (AHS), June 18-21, 2015, Washington DC. The episodic migraine efficacy and onset data will be the subject of an oral platform presentation on Saturday, June 20th, 2015, at 12:00pm ET. The speed of onset data from the chronic migraine study will be presented at a late breaking news poster session on Friday 19th June.
Episodic Migraine Data: A total of 297 individuals, with a an average of 11.4 monthly migraine days and an average of 12.5 headache days were randomized to receive placebo or TEV-48125 (225 mg or 675 mg) given monthly. Patients were permitted to continue using other preventive migraine medications if in stable doses. Both doses of TEV-48125 were superior to placebo and met the primary endpoint defined as decrease in monthly migraine days at month 3 relative to baseline (placebo = -3.46, 225mg = -6.27, p < 0.0001 and 675 mg = -6.09, p < 0.0001) as well as the secondary endpoint, defined as decrease monthly headache days relative to baseline (225 mg, p < 0.001 and 675 mg, p < 0.001).
Results demonstrated that a single administration of both tested doses of TEV-48125 resulted in a statistically significant separation from placebo. Furthermore, a decrease of at least 50% of migraine days for the duration of the study (weeks1-12) were seen in 28% of those receiving placebo relative to 53% (p<0.001) and in 59% (p<0.001) of the individuals given 225mg and 675mg correspondingly. These findings were even further pronounced in the sub group of patients that had not used other preventive medications in parallel – a decrease of at least 50% in episodic migraine days was observed in 22% of those receiving placebo, relative to 66% (p<0.001) and in 67% (p<0.01) of the individuals given 225mg and 675mg correspondingly.
Moreover, after three months of treatment, a decrease of at least 75% in episodic migraine days for the duration of the study, amongst the overall sample, was observed in 11%, 34% (p<0.01) and in 31% (p<0.001) of the individuals given respectively placebo, 225mg and 675mg .The subgroup analysis of individuals that had not used other preventive medications showed such a reduction in 8%, 48% and in 36% of the people given respectively placebo, 225mg and 675mg .
Chronic Migraine: Also to be presented, within the late breaking news poster presentation on Friday June 19th, are new ad hoc analysis data from the Phase IIb chronic migraine study regarding efficacy at early time points. The aim of this evaluation was to examine the efficacy and safety of TEV-48125 at time points during the first month of therapy in people with chronic migraine, characterized by headaches on at least 15 days per month.
Results demonstrated significant decreases in the average number of headache hours, relative to placebo, after only one week of therapy for both TEV-48125 doses, a benefit that extended through the second and third weeks of therapy. The 900mg dose separated from placebo after 3 days of therapy (p<0.05) and the 675/225mg dose separated on day 7 (p<0.01).
In both studies no treatment-related serious adverse events were reported with use of TEV-48125. No other relevant differences in the rate of treatment-emergent adverse events occurred for those receiving TEV-48125 doses relative to placebo. Anti-drug antibodies were the lowest in class up to this point (1.1% for TEV-48125 in this trial, and present before drug exposure).
"The collective data generated from these studies herald promise for millions of people who suffer from episodic and chronic migraines, a disease with substantial implications and unmet needs," stated Marcelo E. Bigal, Teva's Head of Global Clinical Development for Migraine and Headaches. "The very fast onset of preventive response, seen after a single dose of therapy, along with the impressive decrease in migraine days, amongst such highly refractory patients, may bring us a step closer to provide widespread relief to people who suffer from chronic and episodic migraine."
"The promising findings attained, for the first time in both chronic and episodic migraine and in multiple assessed doses, enhance a growing body of evidence that support advancing the development of TEV-48125 to Phase III," said Michael Hayden, Teva's President of Global R&D and Chief Scientific Officer. "Furthermore, these results were achieved in the presence of patients being allowed to remain on existing migraine prevention therapy, an attribute not seen in other reported anti-CGRP studies. We look forward to building on the progress we have made thus far."
About the High Frequency Episodic Migraine Study (ClinicalTrials.gov Identifier: NCT02025556) -- The study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, study comparing the efficacy and safety of two doses of subcutaneous TEV -48125 with placebo for the preventive treatment of high frequency episodic migraine in 297 patients.
Multiple doses were selected for testing to define dose-response and allow selection of doses for a Phase 3 study.
Treatment was administered once every 28 days (i.e.; once monthly) over a 3-month period. The patients were enrolled and randomized to one of three treatment arms receiving high dose TEV-48125, low dose TEV-48125 or placebo, administered subcutaneously once a month. The study was conducted in approximately 60 centers in the USA.
About the Chronic Migraine Study (ClinicalTrials.gov Identifier: NCT02021773) -- The study was a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, multi-dose study comparing TEV-48125 with placebo. Following a 28 day run-in period, qualifying patients (n=264) were randomized to one of three treatment arms receiving high dose TEV-48125 (900mg), low dose TEV-48125 (675/225 mg) or placebo, given subcutaneously once a month for three months.
The study was conducted amongst 264 highly severe chronic migraine patients who suffered from a mean of approximately 162 headache hours per month (approx. 17 migraine days per month, and around 21 days of headache per month). They had suffered from migraines for mean period of 18 years.
Both assessed doses of TEV-48125 were significantly superior to placebo in reducing, relative to baseline, the number of hours with headache (primary endpoint - p < 0.05 and p < 0.01). TEV-48125 also significantly decreased the number of headache days of moderate or severe intensity in month 3 (secondary endpoint - p < 0.05 and p < 0.05).
Subjects had their headache and health information captured daily during the entire study, using an electronic headache diary system. The study was conducted in approximately 60 centers in the USA.
PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today launched next generation risk-based monitoring capabilities, expanding its Perceptive MyTrials® Data-Driven Monitoring (DDM) solution. Data-Driven Monitoring now further enables clients to perform cross-study analysis of quality, risk, and monitoring work effort by combining analytics, reporting and monitoring activity into a single cohesive solution. The enhancements increase a drug developer's ability to demonstrate appropriate oversight and control of site-related risk, quality, and performance while simplifying monitoring governance and execution.
"Centralized monitoring methods are being encouraged by the U.S. Food and Drug Administration (FDA) and other regulatory bodies. By combining our DDM and monitoring solution, PAREXEL clients now have the ability to bridge real-time information gaps between centralized analysts and in-the-field monitoring teams, reducing risk, ensuring documentation, and increasing quality," said Drew Garty, Senior Director, Product Management, PAREXEL.
The Perceptive MyTrials Data-Driven Monitoring solution uses a unique, algorithmic-based approach to clinical monitoring to determine risk and monitor workload, enabling flexible and scalable decision-making. Developed by PAREXEL Informatics, it is a key component of the Perceptive MyTrials platform, an integrated suite of applications for managing clinical trials.
"Our enhanced data-driven monitoring solution provides users with greater control over site risk and resourcing, building on PAREXEL's long-standing track record of developing innovative technologies to continuously improve clinical processes," said Xavier Flinois, President of PAREXEL Informatics. "These updates are the latest example of our continued commitment to make the drug development process more efficient for our clients."
3D Systems (NYSE:DDD) announced that Southend University Hospital established an innovative interventional stroke service using 3DS' ANGIO Mentor Suite simulator at Anglia Ruskin University for efficient and realistic team training for endovascular stroke treatment.
BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage orphan disease-focused biotechnology company, announced today that it will present pre-clinical proofs of concept for two of its therapeutic platforms during June.
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that executives from BioCryst are scheduled to provide a corporate summary and update regarding the Company's programs at the JMP Securities Life Sciences Conference in New York on Tuesday, June 23, 2015 at 3:30 p.m. Eastern Time.
Caladrius Biosciences, Inc. (Nasdaq:CLBS), formerly NeoStem, Inc., a cell therapy leader with a late-stage clinical program for immuno-oncology, announced today that it has entered into a material transfer agreement with the University of Southern California and the California Institute of Technology, concerning next-generation strategies for its core cancer technology.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that Garrett Nichols, MD, MS, Chief Medical Officer of Chimerix, will present at the JMP Life Sciences Conference on Wednesday, June 24, 2015 at 3:00 p.m. ET at the St. Regis Hotel in New York City.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that Sandoz has initiated its U.S. launch of once daily Glatopa™ (glatiramer acetate injection), a generic equivalent of daily COPAXONE® 20 mg, developed under a collaboration agreement between Momenta and Sandoz.
NeuroDerm Ltd. (Nasdaq:NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, announced that its poster presentation, "Stable levodopa plasma levels with ND0612 (LD/CD for subcutaneous infusion) in Parkinson's disease (PD) patients with motor fluctuations," has been selected as part of the 19th International Congress of Parkinson's Disease and Movement Disorders Blue Ribbon Highlights Session, which was held today in San Diego.
Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of Gail K. Boudreaux to its Board of Directors.
Parnell Pharmaceuticals Holdings Ltd (Nasdaq:PARN), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions, today announced that it has entered into a non-dilutive $US11 million term loan agreement with MidCap Financial.
Parnell Pharmaceuticals Holdings Ltd (Nasdaq:PARN), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions, released highlights from its inaugural Investor Day held today in New York City.
Praxsyn Corporation (OTCQB:PXYN) is pleased to announce their compliance with the new OTC standards, allowing the company to remain on the OTCQB tier. The new procedures for being on the OTCQB tier included an application process with a fee.
Premier, Inc. (Nasdaq:PINC) has introduced a comprehensive system that predicts the financial impact of federal payment programs to health systems based on clinical outcomes.
SANUWAVE Health, Inc. (OTCQB:SNWV) today announced it has entered into an amendment to certain provisions of the two promissory notes dated August 1, 2005 between the Company and HealthTronics, Inc. with an aggregate outstanding principal balance of $5,372,743.
Spark Therapeutics (Nasdaq:ONCE) today announced that it, along with collaboration partner, Pfizer Inc., will present the results of preclinical testing that supports the safety and efficacy of the lead compound in their SPK-FIX hemophilia B program at the International Society on Thrombosis and Haemostasis (ISTH) during the ISTH 2015 Congress taking place in Toronto, Ontario, Canada from June 20th through June 25th. ISTH is a global, not-for-profit organization advancing the understanding, prevention, diagnosis and treatment of thrombotic and bleeding disorders and their Congress is the largest global event in the field.
StemCells, Inc. (Nasdaq:STEM), a world leader in the research and development of cell-based therapeutics for the treatment of central nervous system diseases and disorders, announced today that Health Canada has authorized the Company to expand its Phase II clinical trial for chronic cervical spinal cord injury into Canada.
TG Therapeutics, Inc. (Nasdaq:TGTX), today announced updated clinical results from its Phase 2 study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib, the oral BTK inhibitor.
In a release issued yesterday by TRACON Pharmaceuticals (Nasdaq:TCON), the date and time of the conference have been updated to 3:30 pm EDT on Tuesday, June 23, 2015.
Wright Medical Group, Inc. (Nasdaq:WMGI) and Tornier N.V. (Nasdaq:TRNX) today announced that all proposals related to the combination of Wright and Tornier were approved by both Wright's and Tornier's shareholders.
Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, announced today that at the annual general meeting of shareholders held earlier today, shareholders voted to approve a proposal authorizing the board of directors of the Company to amend the Company's certificate of incorporation to effect a reverse stock split of Zogenix's outstanding common shares at an exchange ratio of 1-for-8, and a change in the number of authorized shares of common stock to 50,000,000 shares.