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Venaxis’ APPY1 Test Passes Futility Analysis in Pivotal Clinical Study

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, recently announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company’s pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the first of two futility analyses included in the clinical trial design. Venaxis will host a conference call and webcast tomorrow morning, July 16, 2013, at 8:30 a.m. ET, to discuss the DSMB’s recommendation and to provide a general corporate update.

As Michael J. Fox Returns to Primetime, His Research Foundation Urgently Pursues the Cure for Parkinson’s

Last month, Michael J. Fox returned to television as the star of his own sitcom after more than two decades living with Parkinson’s disease. Fox’s decision to return to primetime has injected Parkinson’s into the national conversation — a conversation already transformed by The Michael J. Fox Foundation for Parkinson’s Research (MJFF), which the actor launched in 2000 with the exclusive goal of funding research to speed a cure for the disease.

Venaxis’ APPY1 Test Passes Final Futility Analysis in Pivotal Clinical Study

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, recently announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company’s pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the second and final futility analysis included in the clinical trial design.

FDA Advisory Committee Recommends Accelerated Approval of Genentech’s Perjeta for Neoadjuvant Use in HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. The FDA will make a decision on whether or not to approve Perjeta for this use by October 31, 2013. If approved, the Perjeta regimen will be the first neoadjuvant breast cancer treatment approved in the United States and the first treatment approved based on pathological complete response (pCR) data, meaning there is no tumor tissue detectable at the time of surgery.

Perjeta is already approved in a number of countries including the United States for people with HER2-positive metastatic breast cancer (an advanced form of the disease in which the cancer has spread to other parts of the body).

The Perjeta application for neoadjuvant use follows a proposed new FDA pathway designed to more quickly bring promising medicines to people with earlier stages of breast cancer, where treatment may have a greater impact.

“More than 6,000 people in the United States die of HER2-positive breast cancer each year,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “The ODAC’s recommendation is a step toward bringing Perjeta to people with HER2-positive early stage breast cancer, where treatment can potentially prevent the disease from returning and spreading.”

Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working and may also reduce a tumor’s size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early stage breast cancer.

The ODAC recommendation was based on a review of results from NEOSPHERE and TRYPHAENA, two Phase II studies of Perjeta in high-risk, HER2-positive early stage breast cancer, as well as on longer-term safety data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer.

The ongoing Phase III APHINITY study will further evaluate Perjeta in the adjuvant setting (after surgery) and compares Perjeta, Herceptin® (trastuzumab) and chemotherapy with Herceptin and chemotherapy in people with HER2-positive early stage breast cancer. The study has completed enrollment with approximately 4,800 people, and the primary endpoint is invasive disease-free survival (IDFS). Genentech has proposed this study as a confirmatory study to the FDA. Data are expected in 2016.

Source: Genentech

Asthmapolis Relaunches as Propeller Health to Advance Broader Respiratory Mission

Asthmapolis, the FDA-cleared mobile health solution for chronic respiratory disease, recently announced the company is changing its name to Propeller Health. The Propeller platform is designed to help patients and their physicians better understand and control respiratory disease to reduce preventable emergency room visits, hospitalizations and unnecessary suffering.

Propeller Health will now offer providers and payers expanded mobile apps for asthma, COPD and other respiratory disease, as well as new sensors for additional inhaled medications pending regulatory clearance.

“COPD is the third leading cause of death in the United States and an extremely costly disease, both in its actual medical costs and the impairments that limit patients with this illness. I believe using technology to help improve adherence and give clinicians early indications of increasing symptoms or exacerbations is valuable and will make an important contribution to helping people successfully manage the disease,” said David Mannino, MD, professor and chair, University of Kentucky Department of Preventive Medicine and Environment, and international expert on the epidemiology and impact of COPD.

Early outcomes have been promising. In the last month, more than two-thirds of Propeller users with asthma were well-controlled or transitioned to well-controlled; by comparison, only 30-40 percent of the general population with asthma has their disease under control. In recent programs, up to 80 percent of patients with asthma remain engaged with Propeller three to six months after enrollment. As a result, the Propeller platform has yielded an 80 percent improvement in medication adherence.

“We need to be doing everything we can to help people manage their health conditions and prevent unnecessary trips to the hospital,” said Rich Roth, vice president of strategic innovation at Dignity Health. “Propeller Health is in a position to make big difference for our patients, which is why we’re excited to see the company moving in this direction.”

Propeller is a novel combination of snap-on sensors, mobile apps, analytics and personal services to empower people to achieve better self-management of their respiratory disease, while reducing the burden of chronic disease management. The HIPAA-compliant solution uses remote monitoring to track when and how often patients use their inhaled medications. This real-time information advances understanding of symptoms and triggers and reveals insights about both medication adherence and rescue medication frequency. Analytics coupled with personalized feedback and individual support, including access to health educators and community managers, inform more productive conversations between Propeller users and their care teams, contributing to positive behavior change, improved quality of life and reduced costs to manage chronic disease like asthma and COPD.

“Over the last year, we’ve grown to be the leading mobile health platform for managing asthma. Today we are charting a new course in chronic respiratory disease management, applying our proven technology and accumulated wisdom to reduce healthcare utilization for COPD,” said David Van Sickle, CEO of Propeller Health. “The Propeller brand broadens our mobile health footprint to include all disease treated with inhaled medications. It more accurately describes how we use technology to achieve momentum in self-management, but with minimal disruption to our users’ daily lives, which in turn helps improve outcomes that reduce cost.”

“Asthmapolis, now Propeller Health, is one of the leaders in mobile health sensors and apps. It is great to see their expansion from asthma to COPD,” said Eric Topol MD, CAO of Scripps Health and author of The Creative Destruction of Medicine (Topol has no relationship with the company). “Further, someday in the future there is now hope that such a platform will be able to markedly reduce asthma attacks and exacerbations of COPD.”

Propeller for COPD is available now, and the company is filing applications for international regulatory clearance for additional sensors later this year.

Source: Propeller Health