Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE: SSS) today
announced its financial results for the period ended June 30, 2008.
Selected Highlights
During the second quarter of 2008 and up to August 27, 2008, SCT
achieved the following accomplishments:
- On April 23, 2008, SCT announced that the U.S. Food and Drug
Administration has allowed its investigational new drug application
(IND) to proceed. The IND-opening study is a U.S. double-blind,
randomized, placebo-controlled Phase IIb clinical trial of its lead
program, NTx(TM)-265, for the treatment of acute ischemic stroke.
The FDA response allows initiation of the U.S. Phase IIb clinical
trial in acute ischemic stroke, led by the Principle Investigator
of the Phase IIa BETAS stroke trial, Dr. Steven C. Cramer, at the
University of California, Irvine. Dr. Cramer is also the co-Lead
Investigator of the Canadian Phase IIb REGENESIS trial along with
Dr. Michael Hill at the Foothills Hospital, University of Calgary.
We anticipate patient enrollment for the U.S. Phase IIb stroke
study to begin in Q4 08 and to be complete in Q2 09.
- On May 28, 2008, SCT announced the enrollment of the first
patient in its REGENESIS Phase IIb stroke trial. The REGENESIS
trial is a double-blind, randomized, placebo-controlled Phase IIb
clinical trial for SCT's lead program, NTx(TM)-265, for the
treatment of acute ischemic stroke.
- On May 30, 2008, the Company announced the appointment of
Thomas R. Franck to the Executive Team as Vice President of
Commercial Planning. Mr. Franck is a 30-year veteran of Procter
& Gamble and has extensive experience and skill as a sales and
marketing director. His current focus on development projects will
play a key role with SCT's pre-Phase III planning. Mr. Franck's
knowledge will assist in managing our pre-launch professional
relations as well as establish the valuation both of individual
programs and the Company as a whole.
- On July 7, 2008, SCT announced the issuance of two keystone
prolactin patents. The U.S. patent, numbered 7,393,830 and entitled
"Prolactin induced increase in neural stem cell numbers" was issued
July 1, 2008. The Australian patent, numbered 2002325711 and
entitled "Prolactin induced increase in neural stem cell numbers
and therapeutical use thereof" was issued January 10, 2008. These
are the first patents to issue in this patent family. These patents
cover the use of prolactin alone, as well as in combination with
other therapeutics that augment recovery and therefore provide a
broad base of protection. We have the exclusive right to the use of
prolactin for treating neurodegenerative diseases and therefore
have a strong foundation to develop many possible products using
prolactin, either as a single therapeutic or in combination with
other neurogenic agents.
- On July 28 2008, SCT announced the presentation of data from
the phase I open labeled uncontrolled pharmacokinetic study of a
single intra-muscular hCG dose in healthy male volunteers at the IX
World Conference on Clinical Pharmacology and Therapeutics in
Quebec City, Quebec. This study demonstrated for the first time
that administering hCG systemically in man resulted in appreciable
amounts of hCG in the central nervous system and established that
drug would be present and available to signal neurogenesis during
the time of an acute neurological injury. Additionally, two forms
of hCG were compared, Pregnyl(TM) derived from human urine and
Ovitrelle(TM) a recombinant form. These two forms of hCG
demonstrated similar pharmacokinetics when administered
peripherally, both in blood and cerebrospinal fluid.
Dr. Alan Moore, President and CEO, commented on the Phase IIb
acute ischemic stroke trial as follows:
"We were very pleased to begin recruiting patients for the
REGENESIS Phase IIb stroke trial in May of this year; however site
initiation and patient enrollment have been slower to date than
anticipated. As a result we are looking to do a portion of the
trial in India. If we are successful in this regard then we may be
able to meet our milestone of completing enrolment in the Phase IIb
clinical stroke trial by the end of this year."
Upcoming 2008 Milestones
- Complete enrollment in the REGENESIS Phase IIb clinical stroke
study for NTx(TM)-265
- Initiate and enroll patients in the Phase IIa clinical study
for Traumatic Brain Injury
- Initiate and enroll patients in the U.S. IND approved Phase
IIb clinical stroke study for NTx(TM)-265
- Complete animal efficacy studies for Multiple Sclerosis
Capital Position
As of June 30, 2008 the working capital (current assets minus
current liabilities) of the Company was $6,515,537 ($9,138,263 as
of December 31, 2007).
Outstanding securities as of June 30, 2008 and August 26, 2008
totaled 103,529,864 common shares, 6,000,000 class B shares,
25,912,500 common share purchase warrants and 7,930,556 common
share options.
Financial Review
The Company's loss for the six month period ended June 30, 2008
increased by $802,835 to $2,892,025 ($0.03 per common share) from
the loss of $2,089,190 ($0.03 per common share) reported for the
six month period ended June 30, 2007. The primary reason for the
change in the reported loss figure is the increase in research and
development costs. The June 30, 2008 "Management Discussion and
Analysis" provides further details on these operating results.
About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two
approved and clinically well-defined drugs, human Chorionic
Gonadotropin (hCG) and Erythropoietin (EPO), targeting the
treatment of stroke. The twin objectives of the regimen are to
stimulate the growth and differentiation of new neurons to replace
the brain cells that were lost or damaged by the stroke, and
importantly, to direct motor, visual and cognitive recovery after
acute ischemic stroke. Animal studies have shown a significant
recovery in motor function after receiving the NTx(TM)-265 regimen
24-48 hours post stroke. Encouraging clinical results in SCT's
Phase IIa BETAS stroke trial were presented at the International
Stroke Conference in February 2008, showing clinically relevant
recovery in 8 of 8 patients who received the complete regimen. SCT
is recruiting patients for the multi-centre, double-blind,
placebo-controlled Phase IIb REGENESIS study for NTx(TM)-265 with
primary endpoints of efficacy.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp.
is a Canadian public biotechnology company (TSX VENTURE: SSS)
focused on the development and commercialization of drug-based
therapies to treat central nervous system diseases. SCT is a leader
in the development of therapies that utilize drugs to stimulate a
patient's own resident stem cells. The company's programs aim to
repair neurological function lost due to disease or injury. The
company's extensive patent portfolio of owned and licensed
intellectual property supports the potential expansion into future
clinical programs in numerous neurological diseases such as
traumatic brain injury and multiple sclerosis.
These securities have not been registered under the United
States Securities Act of 1933, as amended, or the securities laws
of any state, and may not be offered or sold within the United
States or to, or for the account or benefit of U.S. persons unless
an applicable exemption from U.S. registration requirements is
available.
Except for historical information, this press release may
contain forward-looking statements, which reflect the Company's
current expectation regarding future events. These forward-looking
statements involve risk and uncertainties, which may cause but are
not limited to, changing market conditions, the successful and
timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to
time in the Company's ongoing quarterly and annual reporting.
The TSX Venture Exchange does not accept responsibility for the
adequacy or accuracy of this release.
Contacts: Stem Cell Therapeutics Corp. Alan Moore, PhD President
and CEO (403) 245-5495 ext.224 Email: amoore@stemcellthera.com Stem
Cell Therapeutics Corp. Chloe Douglas-Crampton Investor Relations
(403) 245-5495 ext. 221 Email: crampton@stemcellthera.com Website:
www.stemcellthera.com
Sunvest Minerals Corp (TSXV:SSS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Sunvest Minerals Corp (TSXV:SSS)
Historical Stock Chart
From Jul 2023 to Jul 2024