Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE

Patient Recruitment Begins in India for Phase 3 Diabetes Trial

By Pharmaceutical Processing | November 11, 2008

Spherix Incorporated (NASDAQ:SPEX) reported that patient recruitment for its Phase 3 clinical trial of its potential type 2 diabetes drug, Naturlose(R), has begun in India. Expectations for India are to provide more than 300 patients spread across 35 sites for the pivotal Phase 3 trial. “Now that enrollment efforts are underway in India, we believe that the Phase 3 trial will be completed on schedule as reported during the May 2008 Annual Shareholders Meeting. This truly represents a tremendous amount of hard work, both internally and externally, to achieve regulatory approval and patient recruitment in such a short period of time,” said Randy W. Brown, Chief of Operations. Global enrollment is scheduled for completion by the end of the first quarter 2009, and the trial is scheduled to be completed in 2010. Spherix Incorporated also announced the signing of a contract with Amarex, a Contract Research Organization (CRO) located in Germantown, MD, to oversee the work of two India CROs hired to execute the trial in India. “It became quite clear that the trial was not executable solely in the United Sates with our known parameters; therefore, India became an obvious, viable solution. I now expect our ultimate deliverable, a new drug application, to be back on schedule,” said Mr. Brown.

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE