Spherix Announces Start Of Phase 3 Clinical Trial
05/07/07
Spherix Incorporated
(Nasdaq: SPEX) announced today that it has begun its Phase 3 clinical trial
of Naturlose(R) as a treatment for Type 2 diabetes. The first participants
have already been enrolled and the trial has begun. The remaining subjects
continue to be enrolled in the United States and Australia for the trial,
which is scheduled to finish testing in early 2009. Earlier, at an End of
Phase 2 meeting with the Food and drug Administration (FDA), the FDA
accepted Spherix's "proof of concept" for Naturlose as a treatment for
Diabetes based on its preliminary efficacy and safety data, which indicated
that the drug performs the desired function. The Company expresses high
hopes that the fact that the compound has already been found GRAS
(Generally Recognized As Safe) by the FDA means the frequent pitfall for
new drugs, dangerous side reactions, will be avoided.
"This is a major step toward the successful commercialization of
Naturlose," said Richard Levin, President and CEO of Spherix. "We've laid a
solid foundation to conduct a scientifically sound trial, and I'd like to
thank everyone in our BioSpherix Division and our corporate partners who
have worked as a team to move the process along. The sale of our
InfoSpherix subsidiary, currently scheduled to be completed by the end of
the summer (see press release dated April 26, 2007), will come at the
perfect time to strengthen the financial foundation of the trial and keep
it on schedule."
In addition, the Company is testing several different manufacturing
processes as part of satisfying the FDA's chemistry, manufacturing, and
controls requirements for the Naturlose new drug application. Spherix has
signed contracts and begun pilot plant design for a cGMP (current Good
Manufacturing Practices) manufacturing facility to produce Naturlose.
The sale of the InfoSpherix subsidiary will make Spherix exclusively a
biotech company with immediate resources to devote to the development and
commercialization of Naturlose and other medical, health and environmental
products. Dr. Gilbert Levin, inventor of the use of Naturlose as a drug,
stated that, "Our first and persistent effort will be to complete the Phase
3 trial and enter Naturlose into the multi-billion dollar market for drugs
effective against Type 2 diabetes."
Certain statements contained herein are "forward looking" statements as
defined in the Private Securities Litigation Reform Act of 1995. Because
such statements include risks and uncertainties, actual results may differ
materially from those expressed or implied. Factors that could cause actual
results to differ materially from those expressed or implied include, but
are not limited to, those discussed in filings by the Company with the
Securities and Exchange Commission, including the filing on Form 8-K made
on March 3, 1999.
Under its motto, "A World of Solutions," Spherix's mission is to create
value and increase shareholder wealth through innovations that benefit our
clients and the human condition. Spherix offers innovations in information
technology, knowledge management, and biotechnology.
Spherix Incorporated
| << Prev | Pharmacy News Home | Next>> |
|---|






