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News Article | May 30, 2017
Site: www.businesswire.com

SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat, a full service Clinical Research Organization (CRO), congratulates TESARO, Inc. on the approval of ZEJULA™. TESARO’s novel oncology therapy niraparib (trade name, ZEJULA™) was approved on March 27, 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. Niraparib is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor that demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase 3 clinical trial. Veristat worked closely with the TESARO clinical team and would like to congratulate TESARO on this great accomplishment. Veristat worked with TESARO over the past 4 years to provide biostatistical, data standards, SAS programming and medical writing support for the New Drug Application (NDA) submission for niraparib. “We were fortunate to have been brought in by TESARO at a critical point in the pre-analysis phase of their pivotal study, to assist with the development of the statistical methodology, including the appropriate hierarchical strategy to accommodate biomarker information in the key endpoint analyses. The Veristat team then provided the data analysis and medical writing for the pivotal study and the NDA summary documents, in a true collaboration with the TESARO clinical team.” said John Balser, PhD, President and Chief Biostatistician at Veristat. “The Veristat team is honored to have worked with TESARO on this impactful treatment option for women with ovarian cancer,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “We are hopeful to continue our collaboration with TESARO in the development of niraparib as a therapy for additional oncology indications.” Ovarian cancer is the fifth-most frequent cancer causing death to women, where approximately 22,000 cases are diagnosed in the United States each year and more than 65,000 are diagnosed in Europe. FDA approval of niraparib was based upon data from an international, double-blind, placebo-controlled Phase 3 trial that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. “We thank Veristat for their collaborative efforts and support of our NDA submission,” said Mary Lynne Hedley, Ph.D., President and Chief Operating Officer of TESARO, “The Veristat team accepted and achieved our rapid timelines so that we could meet our ultimate goal of bringing this meaningful new medicine to patients and their families as quickly as possible.” Veristat is a consultative clinical research organization (CRO) that is committed to partnering with pharmaceutical, biotechnology and medical device firms to advance their therapies through the clinical development and regulatory submission process. Veristat helps clients solve the unique and complex challenges that arise when trying to accelerate therapies along the development pathway. Veristat provides experience-based strategic decision-making, the operational efficiencies to manage and monitor international trials, the biometrics expertise to collect, analyze & report clinical trial data to various regulatory agencies, and the therapeutic and medical proficiency to mastermind the entire process. Ultimately, we guide our clients to market success so that their therapies become available to improve and save people’s lives. For more information, visit www.veristat.com. *ZEJULA™ is a trademark of TESARO, Inc.


SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat, a full service Clinical Research Organization (CRO), announced today that Veristat and AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, have entered into a Preferred Provider Agreement (PPA). Veristat is currently partnered with AOBiome to conduct a phase II clinical trial for B244, AOBiome’s first-in-class, topical formulation of beneficial ammonia-oxidizing bacteria (AOB), for the treatment of hypertension. "We are very happy with the progress that the Veristat team has made on our phase II study in hypertension, having met the enrollment timelines earlier than planned,” said Todd Krueger, President of AOBiome. “I’m impressed with the strength and breadth of therapeutic experience of their team and value their dedication to our success, transparent communications, and expert management of the hypertension study. Under the PPA, we plan to partner with Veristat to launch additional clinical trials in indications where we think that our bacterial platform will provide novel treatment options to patients.” “Veristat is honored to elevate our partnership with AOBiome,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “Our team has enjoyed partnering with AOBiome and is eager to expand the study of their ground-breaking bacteria platform into new exciting indications.” Specific to the agreement, Veristat will partner with AOBiome to provide ongoing and future clinical research services including strategic consulting, clinical monitoring, clinical data management, biostatistical analysis, SAS programming, clinical protocol and study report writing, project management, and preparation of materials for submission to regulatory authorities. Veristat is a consultative clinical research organization (CRO) that is committed to partnering with pharmaceutical, biotechnology and medical device firms to advance their therapies through the clinical development and regulatory submission process. Veristat helps clients solve the unique and complex challenges that arise when trying to accelerate therapies along the development pathway. Veristat provides experience-based strategic decision-making, the operational efficiencies to manage and monitor international trials, the biometrics expertise to collect, analyze & report clinical trial data to various regulatory agencies, and the therapeutic and medical proficiency to mastermind the entire process. Ultimately, we guide our clients to market success so that their therapies become available to improve and save people’s lives. For more information, visit www.veristat.com.


SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat, a full service Clinical Research Organization (CRO), announced today that it has been recognized for a second consecutive year as one of the top 50 fastest-growing private companies in Massachusetts, taking the #40 slot. “Veristat is honored to be recognized again by the Boston Business Journal as one of the top 50 fastest growing private firms in Massachusetts,” stated Patrick Flanagan, Chief Executive Officer of Veristat. “Our growth is fueled by our clients demand for our strategic and scientific expertise. Guiding them through the design and planning of clinical development programs, the execution of clinical trials and the successful navigation of the regulatory submission process. Over the last year, we added 60 talented team members, expanded our operations into Europe, opened our 5th office located in North Carolina and launched a strategic consulting business unit. We are proud to be a strategic contributor to the biotech industry. The collaborations we participated in over the last 12 months have led to four FDA drug approvals, bringing therapies to market for patients with conditions which previously had no treatment options available.” The Boston Business Journal’s “Fast 50” list includes the top 50 privately held businesses in Massachusetts that recorded the fastest revenue growth from 2013 through 2016. This year, nearly 160 privately held companies were evaluated to determine the rankings. This year’s rankings and full list were published by the Boston Business Journal on May 12, 2017. Veristat is a consultative clinical research organization (CRO) that is committed to partnering with pharmaceutical, biotechnology and medical device firms to advance their therapies through the clinical development and regulatory submission process. Veristat helps clients solve the unique and complex challenges that arise when trying to accelerate therapies along the development pathway. Veristat provides experience-based strategic decision-making, the operational efficiencies to manage and monitor international trials, the biometrics expertise to collect, analyze & report clinical trial data to various regulatory agencies, and the therapeutic and medical proficiency to mastermind the entire process. Ultimately, we guide our clients to market success so that their therapies become available to improve and save people’s lives. For more information, visit www.veristat.com.


Heppner D.G.,NewLink Genetics | Kemp T.L.,NewLink Genetics | Martin B.K.,NewLink Genetics | Ramsey W.J.,NewLink Genetics | And 8 more authors.
The Lancet Infectious Diseases | Year: 2017

Background: The 2014 Zaire Ebola virus outbreak highlighted the need for a safe, effective vaccine with a rapid onset of protection. We report the safety and immunogenicity of the recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSV(increment)G-ZEBOV-GP) across a 6 log10 dose range in two sequential cohorts. Methods: In this phase 1b double-blind, placebo-controlled, dose-response study we enrolled and randomly assigned healthy adults (aged 18-61 years) at eight study sites in the USA to receive a single injection of vaccine or placebo, administered by intramuscular injection. In cohort 1, participants were assigned to receive 3 × 103, 3 × 104, 3 × 105, or 3 × 106 PFU doses of rVSV(increment)G-ZEBOV-GP or placebo. In cohort 2, participants were assigned to receive 3 × 106, 9 × 106, 2 × 107, or 1 × 108 PFU doses of rVSV(increment)G-ZEBOV-GP or placebo. Participants were centrally allocated by the study statistician to vaccine groups or placebo through computer-generated randomisation lists. The primary safety outcome was incidence of adverse events within 14 days in the modified intention-to-treat population (all randomly assigned participants who received vaccine or placebo), and the primary outcome for immunogenicity was IgG ELISA antibody titres at day 28 in the per-protocol population. Surveillance was enhanced for arthritis and dermatitis through to day 56. This study is registered with ClinicalTrials.gov, number NCT02314923. Findings: Between Dec 26, 2014, and June 8, 2015, 513 participants were enrolled and randomly assigned; one was not immunised because of unsuccessful phlebotomy. In cohort 1, 256 participants received vaccine (3 × 103 [n=64], 3 × 104 [n=64], 3 × 105 [n=64], or 3 × 106 PFU [n=64]) and 74 received placebo. In cohort 2, 162 participants received vaccine (3 × 106 [n=20], 9 × 106 [n=47], 2 × 107 [n=47], or 1 × 108 PFU [n=48]) and 20 received placebo. Most adverse events occurred in the first day after vaccination, and were mild to moderate in intensity, of a short duration, and more frequent at high vaccine doses (9 × 106 PFU and greater). At the 2 × 107 PFU dose (used in phase 3 trials), the most common local adverse events versus placebo within the first 14 days were arm pain (57·4% [27 of 47] vs 7·4% [seven of 94]) and local tenderness (59·6% [28 of 47] vs 8·5% [eight of 94]). The most common systemic adverse events at the 2 × 107 PFU dose versus placebo, occurring in the first 14 days, were headache (46·8% [22 of 47] vs 27·7% [26 of 94]), fatigue (38·3% [18 of 47] vs 19·1% [18 of 94]), myalgia (34·0% [16 of 47] vs 10·6% [10 of 94]), subjective fever (29·8% [14 of 47] vs 2·1% [two of 94]), shivering or chills (27·7% [13 of 47] vs 7·4% [seven of 94]), sweats (23·4% [11 of 47] vs 3·2% [three of 94]), joint aches and pain (19·1% [nine of 47] vs 7·4% [seven of 94]), objective fever (14·9% [seven of 47] vs 1·1% [one of 94]), and joint tenderness or swelling (14·9% [seven of 47] vs 2·1% [two of 94]). Self-limited, post-vaccination arthritis occurred in 4·5% (19 of 418) of vaccinees (median onset 12·0 days [IQR 10-14]; median duration 8·0 days [6-15]) versus 3·2% (three of 94) of controls (median onset 15·0 days [6-20]; median duration 47·0 days [37-339]), with no apparent dose relationship. Post-vaccination dermatitis occurred in 5·7% (24 of 418) of vaccinees (median onset 9·0 days [IQR 2-12]; median duration 7·0 days [4-9]) versus 3·2% (three of 94) of controls (median onset 5·0 days [3-53]; median duration 33·0 days [5-370]). A low-level, transient, dose-dependent viraemia occurred in concert with early reactogenicity. Antibody responses were observed in most participants by day 14. IgG and neutralising antibody titres were dose-related (p=0·0003 for IgG ELISA and p<0·0001 for the 60% plaque-reduction neutralisation test [PRNT60] by linear trend). On day 28 at the 2 × 107 PFU dose, the geometric mean IgG ELISA endpoint titre was 1624 (95% CI 1146-2302) and seroconversion was 95·7% (95% CI 85·5-98·8); the geometric mean neutralising antibody titre by PRNT60 was 250 (176-355) and seroconversion was 95·7% (85·5-98·8). These robust immunological responses were sustained for 1 year. Interpretation: rVSV(increment)G-ZEBOV-GP was well tolerated and stimulated a rapid onset of binding and neutralising antibodies, which were maintained through to day 360. The immunogenicity results support selection of the 2 × 107 PFU dose. Funding: Biomedical Advanced Research and Development Authority, US Department of Health and Human Services. © 2017 Elsevier Ltd.


Monath T.P.,Xcellerex | Fowler E.,Xcellerex | Johnson C.T.,Johnson City Clinical Trials | Balser J.,Veristat | And 3 more authors.
New England Journal of Medicine | Year: 2011

BACKGROUND: Yellow fever is a lethal viral hemorrhagic fever occurring in Africa and South America. A highly effective live vaccine (17D) is widely used for travelers to and residents of areas in which yellow fever is endemic, but the vaccine can cause serious adverse events, including viscerotropic disease, which is associated with a high rate of death. A safer, nonreplicating vaccine is needed. METHODS: In a double-blind, placebo-controlled, dose-escalation, phase 1 study of 60 healthy subjects between 18 and 49 years of age, we investigated the safety and immunogenicity of XRX-001 purified whole-virus, β-propiolactone-inactivated yellow fever vaccine produced in Vero cell cultures and adsorbed to aluminum hydroxide (alum) adjuvant. On two visits 21 days apart, subjects received intramuscular injections of vaccine that contained 0.48 μg or 4.8 μg of antigen. Levels of neutralizing antibodies were measured at baseline and on days 21, 31, and 42. RESULTS: The vaccine induced the development of neutralizing antibodies in 100% of subjects receiving 4.8 μg of antigen in each injection and in 88% of subjects receiving 0.48 μg of antigen in each injection. Antibody levels increased by day 10 after the second injection, at which time levels were significantly higher with the 4.8-μg formulation than with the 0.48-μg formulation (geometric mean titer, 146 vs. 39; P<0.001). Three adverse events occurred at a higher incidence in the two vaccine groups than in the placebo group: mild pain, tenderness, and (much less frequently) itching at the injection site. One case of urticaria was observed on day 3 after the second dose of 4.8 μg of vaccine. CONCLUSIONS: A two-dose regimen of the XRX-001 vaccine, containing inactivated yellow fever antigen with an alum adjuvant, induced neutralizing antibodies in a high percentage of subjects. XRX-001 has the potential to be a safer alternative to live attenuated 17D vaccine. (Funded by Xcellerex; ClinicalTrials.gov number, NCT00995865.) Copyright © 2011 Massachusetts Medical Society.


Labrie F.,EndoCeutics Inc. | Montesino M.,EndoCeutics Inc. | Archer D.F.,Clinical Research Center | Lavoie L.,EndoCeutics Inc. | And 6 more authors.
Climacteric | Year: 2015

The aim was to analyze the opinion of the male partner of women treated for vulvovaginal atrophy (VVA) with intravaginal 0.50% DHEA (prasterone), thus providing information on both members of the couple.Methods On a voluntary basis, in a prospective, randomized, double-blind and placebo-controlled phase-III clinical trial, the male partner filled a questionnaire at baseline and at 12 weeks stating his observations related to his penis and intercourse before and after VVA treatment.Results Sixty-six men having a partner treated with intravaginal DHEA and 34 others having a partner treated with placebo answered the questionnaires. Concerning the feeling of vaginal dryness of their female partner, the severity score following DHEA treatment improved by 81% (0.76 units) over placebo (p = 0.0347). Thirty-six percent of men having a partner treated with DHEA did not feel the vaginal dryness of the partner at the end of treatment compared to 7.8% in the placebo group. When analyzing the situation at 12 weeks compared to baseline, an improved score of 1.09 units was the difference found for the DHEA group compared to 0.76 for the placebo group (p = 0.05 vs. placebo). In the DHEA group, 38% of men scored very improved compared to 18% in the placebo group. No adverse event has been reported.Conclusion The male partner had a very positive evaluation of the treatment received by his female partner. © 2015 International Menopause Society.


PubMed | Clinical Research Center, EndoCeutics Inc., Veristat and Consulting Inc.
Type: | Journal: The Journal of steroid biochemistry and molecular biology | Year: 2015

The objective of the present phase III, placebo-controlled, double-blind, prospective and randomized study was to confirm the efficacy of daily intravaginal administration of 0.50% dehydroepiandrosterone (DHEA; prasterone) ovules for 12 weeks on moderate to severe dyspareunia (or pain at sexual activity) as most bothersome symptom of vulvovaginal atrophy (VVA) while having serum steroid concentrations within normal postmenopausal values. To this end, serum levels of DHEA, DHEA-sulfate (DHEA-S), Androst-5-ene-diol-3, 17-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E1), estradiol (E2), estrone sulfate (E1-S), androsterone glucuronide (ADT-G), and androstane-3, 17-diol 17-glucuronide (3-diol-17G) were measured by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). In agreement with the mechanisms of intracrinology, all serum sex steroids and metabolites concentrations after 12 weeks of daily intravaginal administration of 0.50% DHEA remain well within the limits of normal postmenopausal women. More specifically, the 12-week serum E2 concentration was measured at 22% below the average normal postmenopausal value (3.26 versus 4.17 pg/ml), thus eliminating any fear of E2 exposure outside the vagina. In addition, serum E1-S, a particularly reliable indicator of global estrogenic activity, shows serum levels practically superimposable to the value observed in normal postmenopausal women (219 versus 220 pg/ml). Similarly, serum ADT-G, the major metabolite of androgens, remains within normal postmenopausal values. The present data confirm the intracellular transformation of DHEA in the vagina resulting in local efficacy without any systemic exposure to sex steroids, observations which are in agreement with the physiological mechanisms of menopause.


Signs Agreement with Cytovance for Development of Commercial Scale Antibody Manufacturing, and with Veristat for Clinical Trial Management Appoints New Auditors for Quest PharmaTech and OncoQuest EDMONTON, Dec. 7, 2016 /PRNewswire/ - OncoQuest Inc. ("OncoQuest"),...


News Article | November 1, 2016
Site: www.businesswire.com

SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat, a full service consultative Clinical Research Organization (CRO), announced today the formal launch of its Strategic Decision Consulting service offering.


News Article | November 7, 2016
Site: www.businesswire.com

SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat announced that it has appointed James (Jim) Roach, M.D., as its new Chief Medical Officer to bolster the expansion of its clinical operations, medical and regulatory affairs offering.

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