|[March 03, 2014]
FDA Grants "Orphan Drug" Designation for Genervon's Breakthrough Multi-Target ALS Bio-Drug GM604
PASADENA, Calif. --(Business Wire)--
Genervon Biopharmaceuticals announced today that the U.S. Food and Drug
Administration (FDA) has granted an "orphan drug" designation to
Genervon's GM604 (a.k.a. GM6) bio-drug for the treatment of Amyotrophic
Lateral Sclerosis (ALS). The FDA also granted GM604 a "fast-track"
designation for ALS in 2013.
In addition, the U.S. Patent and Trademark Office recently notified
Genervon that it will be issued U.S. patent #8673852 on March 18, 2014
for its novel proprietary peptide GM6. GM6 is Genervon's first-in-class,
multi-target, master regulator bio-drug that has shown itself to be
highly efficacious in a number of therapeutic applications. This brings
a total of 53 U.S. and international patents issued to Genervon.
The following lists the clinical trials involving GM6 currently
sponsored by Genervon:
ALS Phase 2a Clinical Trial with GM604 (a.k.a. GM6,
Genervon finished enrolling ALS
patients in January 2014 for its ALS Phase 2a trial under the direction
of Dr. Hiroshi Mitsumoto (Columbia University Medical Center i New
York) and Drs. Nazem Atassi and Merit Cudkowicz (Massachusetts General
Hospital in Boston). Twelve ALS patients, including four in a placebo
group, have completed two weeks of dosing.
Parkinson's disease Phase 2a Clinical Trial with GM608 (a.k.a.
GM6, clinicaltrials.gov NCT01859381)
Genervon will finish enrolling
all six Parkinson's disease (PD) patients this month for its PD Phase 2a
trial at Columbia University Medical Center in New York under the
direction of Drs. Stanley Fahn and Cheryl Waters.
Ischemic Stroke Phase 2 Clinical Trial with GM602 (a.k.a. GM6,
Genervon will finish enrolling
ischemic stroke (IS) patients next month for its IS Phase 2 trial at
eight sites across the country.
Each of these three Phase 2 trials is a double-blinded, randomized,
placebo-controlled trial. GM6 has been safe and well-tolerated in each
trial. Genervon expects to present the analysis of the unblinded results
of all three trials by the third quarter of 2014.
In the 1990s, Genervon hypothesized that neurological and
neurodegenerative diseases involve the interplay of multiple targets and
processes in an interactive dynamic mechanism and network. Most
researchers in the field have by now confirmed that ALS and other
neurological disorders are remarkably complex, involving many different
biological systems and potential therapeutic targets. Genervon believes
that this is one reason why single-target drugs have uniformly failed in
previous clinical trials of ALS.
Using breakthrough proprietary biotechnologies, Genervon scientists
discovered GM6, an endogenous, multi-target, master regulator signaling
peptide. Highly expressed in week 9 of human embryonic/fetal gestation,
GM6 plays a significant role in nervous system development, protection,
Genervon is a privately funded clinical stage biopharmaceutical company
in California developing breakthrough multi-target bio-drugs to address
the world's critical unmet medical needs.
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