March 2018

Briefs

House Republicans Pass Right-to-Try Bill

March 26, 2018

The House passed its version of federal right-to-try legislation, sending it for reconsideration by the Senate, which passed a similar bill last August. The bill, H.R. 5247, had failed to garner enough votes on the floor last week to fast-track the bill under suspension of the House rules. Republicans that favor the legislation said they believe terminally ill patients, that have exhausted all other treatment options, should be able to try unproven therapies as a last resort. “For those patients caught between the traditional drug approval delays, a clinical trial process for which they do not qualify, and limited time, this right-to-try establishes the freedom for patients to try therapies in situations where the benefits far outweigh the risks,” said bill sponsor Rep. Brian Fitzpatrick (R-Pa.). Most Democrats opposed the bill, arguing that it would hinder the FDA’s oversight of investigational treatments — and contending that patients already have a program through which they can request access to experimental treatments. In addition, four former FDA commissioners — Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach — as well as over 80 patient advocacy organizations opposed the bill because it would remove agency protections from the process.

Pipeline

Pipeline new from AstraZeneca, Cavion, Heron and AMO Pharma

March 26, 2018

Company Drug/Device Medical Condition Status
Avita Medical RECELL deep partial-thickness (second-degree) burns Phase I trials initiated
Surface Oncology SRF231 advanced solid tumors and hematologic malignancies Phase I trials initiated
Cidara Therapeutics, Inc. rezafungin acetate candidemia and/or invasive candidiasis Phase II trials initiated
Arena Pharmaceuticals, Inc. etrasimod ulcerative colitis Phase II trials initiated
AMO Pharma AMO-02 (tideglusib) neuromuscular diseases Phase II trials initiated
Cavion, Inc. CX-8998 generalized epileptic syndromes Phase IIa trials initiated
Antibe Therapeutics ATB-346 gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth Phase IIb trials initiated enrolling 244 subjects
Regeneron Pharmaceuticals, Inc. EYLEA (aflibercept) moderately severe to severe non-proliferative diabetic retinopathy Phase III trials initiated
AstraZeneca dapagliflozin type 2 diabetes Phase III trials initiated enrolling 321 subjects
Heron Therapeutics HTX-011 Bunionectomy and hernia repair Phase III trials initiated enrolling 412 subjects
Trial Results

Genentech Releases Results for Phase III Lung Cancer Study

March 26, 2018

Genentech announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ plus chemotherapy (carboplatin and ABRAXANE) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial treatment of people with advanced squamous non-small cell lung cancer (NSCLC). The study enrolled 1,021 people who were randomized equally (1:1:1) IMpower131 is a Phase III, open-label, multicenter, randomized study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and nab-paclitaxel or TECENTRIQ in combination with carboplatin and paclitaxel versus chemotherapy alone in people with stage IV squamous NSCLC. During the treatment-induction phase, people in Arm A received four or six cycles of TECENTRIQ plus carboplatin and paclitaxel, given on day one of each 21-day cycle. During the treatment-induction phase, people in Arm B received four or six cycles of TECENTRIQ, carboplatin and nab-paclitaxel. During the treatment-induction phase, people in Arm C received four or six cycles of carboplatin and nab-paclitaxel. IMpower131 met its PFS co-primary endpoint per study protocol.

CWMarketplace

March Top 10 Industry Provider Profile Page

March 26, 2018

CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at (617) 948-5100.

Click on any provider to view the company’s complete online profile or search more profiles.

Contract Research Organizations
Accelovance

Accelovance
Rockville, MD
(240) 238-4900
information@accelovance.com

Accelovance operates three core divisions: a global CRO, patient recruitment and a clinical call center that assists in recruitment, retention, long-term follow-up and post-marketing surveillance.

Concentrics Research

Concentrics Research
Indianapolis, IN
(800) 800-5525
julie.aker@concentricsresearch.com

Concentrics has conducted over 1,100 clinical studies. Core staff includes four nurses, two study coordinators, two research assistants, 10 physicians and four dental hygienists.

Confidence Pharmaceutical Research

Confidence Pharmaceutical Research
Burlington, CA
(401) 965-3377
anna.ravdel@confidenceresearch.com

Confidence Pharmaceutical Research is a CRO and a vendor management organization that helps clinical trial sponsors run better trials. Our focus is on transparency, reducing waste, and producing rigorous metrics.

PRA Health Sciences

PRA Health Sciences
Raleigh, NC
(919) 786-8200
prahealthsciences@prahs.com

With 13,000+ employees covering 80+ countries, PRA provides a global presence combined with an in-depth knowledge of local regulations, standards of care and cultural customs.

PSI Pharma Support America Inc.

PSI Pharma Support America Inc.
King of Prussia, PA
(919) 249-2660
natania.barron@psi-cro.com

PSI is home to 1,400 employees around the world, of which 250 hold medical degrees, with capabilities across all phases of clinical development from Phase I –IV.

Diagnostic Ultrasound Services, Other
Vascular Imaging Solutions and Clare Diagnostic Echo & Research

Vascular Imaging Solutions and Clare Diagnostic Echo & Research
Surprise, AZ
(623) 262-7199
eileen.spengler@gmail.com

Source for diagnostic ultrasound services. We provide the equipment, trained sonographers and image storage system.

Investigative Site Networks (non SMO)
Evolution Research Group, LLC & Thievon-Wright Consulting Group, LLC

Evolution Research Group, LLC & Thievon-Wright Consulting Group, LLC
Watchung, NJ
info@cnssites.com

ERG represents Thievon-Wright Consulting Group and a 15-member network of owned and affiliate clinical research sites.

Insearch

Insearch
Tampa, FL
(727) 544-4842
mike.ero@machaondiagnostics.com

Insearch is a clinical business development company that offers personalized service, at no charge, to Pharma and CROs looking for appropriate PIs/sites for their trials.

Technology Solutions
Splash Clinical

Splash Clinical
Wauwatosa, WI
(414) 443-3280
matt@splashclinical.com

As a wholly-owned subsidiary of Teuteberg, Splash intends to revolutionize patient recruitment with innovative online and social media marketing services.

Techorizon

Techorizon
Verona, Italy
+39 045 8222888
silvio.severini@techorizon.com

In February 2011,Techorizon achieved the ISO Certification 9001:2008, and it considers such accreditation the basis of the company.

Features

Electronic Storage of Work Correspondence – GCP Questions, FDA Answers

March 19, 2018

FDA regulations provide guidance for the handling and storage of electronic records, including email. The regulations do not, however, provide answers for every possible question. FDA’s Office of Good Clinical Practice responds to questions from the public interpreting FDA’s position, offering advice on how to proceed and pointing out key documents and resources that provide more guidance. The following question and OGCP answer regarding the electronic storage of correspondence comes from their website.

Briefs

IBM Watson Helps Increase Cancer Trial Enrollment

March 19, 2018

In the span of nearly a year, Mayo Clinic’s use of IBM’s Watson computing system for matching patients to clinical trials helped increase enrollment by an average of 80 percent in studies of systemic therapies for breast cancer. Over 11 months, the time needed to screen an individual patient for clinical trial matches also fell when compared to traditional manual methods, they said in a joint press release. In July 2016, Mayo began using the system with a team of screening clinical research coordinators in its ambulatory practice for patients with breast cancer. “This has enabled all patients to be screened for all available clinical trial opportunities,” said Mayo oncologist Tufia Haddad, physician leader for the Watson matching project. The two organizations also plan to expand training and use of the system, including using Watson in additional cancer types, as well as other aspects of cancer therapy, such as surgery, radiation and supportive care. Currently, the system is trained to support clinical trial matching for breast, lung and gastrointestinal cancers.