For Wednesday, September
AXTG, CORT, UDTT, AMZN, NABI
Our Stocks to Watch for tomorrow
include XTL Biopharmaceuticals (NASD: XTLB) Axis Technologies (OTC:
AXTG), Corcept Therapeutics (NASD: CORT), Universal Detections Technologies
(OTCBB: UDTT), Santa Fe Gold Corp. (OTCBB: AMZN), Nabi Biopharmaceuticals
BIOPHARMACEUTICALS (NASD: XTLB)
"Up 40.3% on Tuesday"
XTL Biopharmaceuticals Ltd. ("XTL") is
engaged in the development of therapeutics for the treatment of neuropathic
pain and hepatitis C. XTL is developing Bicifadine, a serotonin and norepinephrine
reuptake inhibitor, for the treatment of diabetic neuropathic pain. XTL
is also developing several novel pre-clinical hepatitis C small molecule
inhibitors. XTL also has an active in-licensing and acquisition program
designed to identify and acquire additional drug candidates. XTL is publicly
traded on the NASDAQ, London, and Tel- Aviv Stock Exchanges (NASDAQ: XTLB;
LSE: XTL; TASE: XTL).
10 - XTL Biopharmaceuticals
Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of
Diabetic Neuropathic Pain
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB;
LSE: XTL; TASE: XTL) recently announced the initiation of a Phase IIb
clinical trial of Bicifadine - a serotonin and norepinephrine reuptake
inhibitor (SNRI) - for the treatment of diabetic neuropathic pain.
Bicifadine is being developed for the treatment
of diabetic neuropathic pain which represents a significant unmet medical
need in the rapidly growing multi-billion dollar neuropathic pain market.
Bicifadine is a member of the SNRI drug class, a proven class in the treatment
of diabetic neuropathic pain. Bicifadine's efficacy in reducing pain has
been clearly demonstrated in over 15 clinical trials in acute pain, and
its favorable safety profile has been established in over 3,000 patients.
Importantly, Bicifadine has a unique ratio of reuptake inhibition of serotonin
versus norepinephrine, which differentiates it from other members of the
SNRI drug class.
The Phase IIb trial that was launched today
is aimed at demonstrating the efficacy of Bicifadine in diabetic neuropathic
pain, using a study design that is similar to the successful registration
trials of Cymbalta®, a member of the SNRI class that is approved for
this indication, and other approved agents for neuropathic pain.
The Phase IIb study is a randomized, double-blind,
placebo-controlled study comparing 200mg 3x/day (tid) and 400mg 3x/day
(tid) of Bicifadine versus placebo, with a 1:1:1 randomization between
the three arms, in patients with diabetic neuropathic pain. The Phase
IIb study is designed to enroll approximately 330 patients. Approximately
45 clinical centers in the United States, Europe and India will participate
in the study. Following randomization, all patients will enter a 2-week
titration period to allow them to gradually escalate up to their target
treatment dose. This will be followed by a 12-week steady-state treatment
period at the target treatment dose. The primary endpoint of the study
is to compare the efficacy of each of the two active doses of bicifadine
(200mg tid and 400mg tid) versus placebo in reduction of pain associated
with diabetic neuropathy, at baseline (at the time of randomization) versus
week 14 (week 12 of the steady-state phase). Pain will be measured based
on a 24-hour pain rating using the 11-point Pain Intensity Numeric Rating
Scale (formerly referred to as the LIKERT scale).
The lead investigators in the study are
Dr. Andrew Boulton, M.D. and Dr. Sherwyn Schwartz, M.D. Dr. Boulton is
Professor of Medicine, Division of Endocrinology, Diabetes and Metabolism,
at the University of Miami and the University of Manchester, UK. Professor
Boulton has been active in clinical research in diabetic neuropathy over
the last 25 years and has published over 250 peer reviewed articles on
the subject. He was co-chair of the committee that formulated the American
Diabetes Association statement on diabetic neuropathy published in Diabetes
Care in 2005. Dr. Schwartz is Chief Executive Officer and Chief Medical
Officer of DGD Research, Inc. which is the largest diabetes and endocrinology
practice in the United States. Dr. Schwartz has over 20 years of clinical
research experience in diabetes and diabetic complications, and has participated
in hundreds of clinical trials in the field.
TECHNOLOGY (OTC: AXTG)
“Up 38.4% on Tuesday”
Axis Technologies Group, Inc. conducts
its business through a wholly owned subsidiary, Axis Technologies, Inc.,
a Delaware corporation headquartered in Lincoln, Nebraska. Axis Technologies,
Inc. designs, manufactures and markets a proprietary line of energy-saving
and daylight harvesting electronic dimming ballasts for the commercial
lighting industry. The company's target market is small to large commercial
users of fluorescent lighting including office buildings, wholesale and
retail buildings, hospitals, schools, and government buildings. In 2002,
Underwriters Laboratory (UL) approved Axis products for sale in both the
United States and Canada. The Axis Dimming/Daylight Harvesting (DDH) ballast
is priced competitively and is the only daylight harvesting ballast system
that can be marketed as a replacement for a standard ballast.
11 - Axis Begins
Shipping Dimming/Daylight Harvesting Ballasts to HD Supply, A Former Subsidiary
of Home Depot
Axis Technologies Group, Inc. (Pink Sheets:AXTG)
announced today that after receiving initial purchase orders in April
2007, the Company has begun shipping the Axis Dimming/Daylight Harvesting
(DDH) Ballast to HD Supply™. HD Supply is a former subsidiary of
The Home Depot, Inc. (NYSE:HD) and was sold by the company on August 30,
2007. For ten years HD Supply was considered the wholesale arm of Home
Depot catering primarily to the commercial market selling to builders,
contractors, government entities, industrial businesses and maintenance
“We are delighted to add HD
Supply to our growing list of high profile customers” said Jim Erickson,
President of Axis. “We have worked hard to build market awareness
of our product and now the market is responding. I believe we are in the
right place at the right time with our energy saving ballast as Green
initiatives continue to dominate the headlines.”
Ballasts are an electronic component that
regulates voltage in fluorescent lighting. Axis Technologies Group, Inc.
has developed a proprietary new ballast that focuses on expanding daylight
harvesting into mainstream fluorescent lighting applications The patented
Axis Dimming/Daylight Harvesting Ballast is a new technology that transforms
the ballast, a once standard lighting industry staple, into a dynamic
energy saving system that can reduce lighting energy costs by up to 70%--savings
that is acknowledged by an increasing list of utilities across the United
States and Canada offering rebates to their customers. The Axis DDH Ballast
utilizes an individual photo sensor to automatically adjust the amount
of electrical current flowing to the light fixture, and then dims or increases
lighting in response to the amount of available sunlight that may be harvested
from available windows and sunlight. The Axis DDH Ballast avoids "over-lit"
conditions that increase energy costs by keeping lighting "tuned" to the
desired level in a designated area.
THERAPEUTICS (NASD: CORT)
"Up 37.6% on Tuesday"
Corcept Therapeutics Incorporated is a
pharmaceutical company engaged in the development of drugs for the treatment
of severe psychiatric and metabolic diseases. Corcept's lead product,
CORLUX, is currently in Phase 3 clinical trials for the treatment of the
psychotic features of psychotic depression. The drug is administered orally
to psychotic depression patients once per day for seven days. CORLUX,
a potent GR-II antagonist, appears to mitigate the effects of the elevated
and abnormal release patterns of cortisol seen in psychotic depression.
In June 2007, Corcept Therapeutics announced positive results from its
proof of concept study evaluating the ability of CORLUX to mitigate weight
gain associated with olanzapine, a commonly used antipsychotic medication.
The Company is in the process of fully evaluating all of the data from
the study and considering its next steps. For additional information about
the company, please visit www.corcept.com
11 - Corcept Therapeutics
Receives FDA Notification Opening IND for CORLUX(R) for the Treatment
of Cushing's Syndrome
Corcept Therapeutics Incorporated (NASDAQ:
CORT) recently announced that it has received notification from the Food
and Drug Administration (FDA) that the FDA has opened the Investigational
New Drug application (IND) for CORLUX for the treatment of Cushing's Syndrome.
CORLUX is a cortisol receptor (GR-II) antagonist..
In July 2007, the Company announced the
receipt of Orphan Drug Designation for CORLUX for the treatment of Cushing's
Syndrome. Drugs that receive Orphan Drug Designation obtain seven years
of marketing exclusivity from the date of drug approval as well as tax
credits for clinical trial costs, marketing application filing fee waivers
and assistance from the FDA in the drug development process.
In the communication regarding the opening
of the IND, the FDA indicated that a single study may provide a reasonable
basis for the submission of a New Drug Application (NDA) for Corlux for
the treatment of Cushing's Syndrome, which allows us to initiate the 50-patient
open label study defined by the protocol submitted with the application
for the IND. Corcept has begun qualifying potential sites for this study
and expects to open the trial for enrollment late in the fourth quarter
DETECTION TECHNOLOGY (OTCBB: UDTT)
"Up 37.5% on Tuesday"
Universal Detection Technology is a developer
of monitoring technologies, including bioterrorism detection devices.
The Company on its own and with development partners is positioned to
capitalize on opportunities related to Homeland Security. For example,
the Company, in cooperation with NASA, has developed a bio-terror 'smoke'
detector that detects certain biohazard substances. For more information,
please visit http://www.udetection.com.
11 - Universal
Detection Technology Receives Purchase Order From the British Government
Universal Detection Technology (OTCBB:UDTT)(www.udetection.com),
a developer and marketer of early-warning monitoring technologies to protect
people from bioterrorism, announced recently that it has received a purchase
order from the government of England. The order is for consumables and
software for two of the Company's BSM-2000 anthrax detection systems previously
purchased by the British Government. The order also includes point detection
kits which are capable of detecting anthrax, Ricin toxin, Botulinum toxin,
plague, and SEBs.
"We are very pleased to have reached this
milestone. The British Government was the first customer for our BSM-2000
product line and we are excited to have received a new order from them
for additional consumables and software for their systems. We are also
pleased to have the opportunity to supply them with our point bioterrorism
detection kits," said Jacques Tizabi, UDTT's Chief Executive Officer.
FE GOLD CORP (OTCBB: AZMN)
"Up 33.3% on Tuesday"
Santa Fe Gold Corp (OTCBB: AZMN) is a
U.S.-based mining and exploration company focused on acquiring and developing
gold, silver, copper and industrial mineral properties. The company owns
the Summit silver-gold property and a mill site and processing equipment
in southwestern New Mexico; mineral lease rights to the Ortiz gold property
in north-central New Mexico, believed to contain two million ounces of
gold; the Black Canyon mica mine and processing facility near Phoenix,
Ariz.; and a large resource of micaceous iron oxide (MIO) in western Arizona.
Santa Fe Gold intends to build a portfolio of high-quality, diversified
mineral assets with an emphasis on precious metals. To learn more about
the company, visit www.santafegoldcorp.com.
11 - Santa Fe
Gold Corp Announces New Ticker Symbol of SFEG Effective as of September
Santa Fe Gold Corp (OTC Bulletin
Board: AZMN), formerly Azco Mining Inc., a U.S.-based mining
and exploration enterprise focused on gold, silver, copper and industrial
minerals, today announced that effective September 12, 2007, its new ticker
symbol will be “SFEG” for trading on the OTB Bulletin Board.
Pierce Carson, CEO, said, “Our recent
name change and new ticker symbol reflect the company’s strategic
objective of building a mid-tier precious metals exploration and mining
“We plan for production to
begin initially at our Summit silver-gold property, to be followed by
our Ortiz gold property. We also intend to expand our precious metals
resource base, which exceeds 2 million ounces of gold, through aggressive
exploration programs and acquisition of additional properties.
BIOPHARMACEUTICALS (NASD: NABI)
"Up 22.9% on Tuesday"
Nabi Biopharmaceuticals leverages its
experience and knowledge in powering the immune system to develop and,
in certain areas, market products that target serious medical conditions
in the areas of hepatitis and transplants, gram positive bacterial infections
and nicotine addiction. We are a vertically integrated company with sales
of antibodies and other biologics, including Nabi-HB(R) [Hepatitis B Immune
Globulin (Human)], a pipeline of products in various stages of development
and a state-of-the-art manufacturing capability. The company operates
through two strategic business units: Nabi Biologics and Nabi Pharmaceuticals.
Nabi Biologics has responsibility for the company's protein and immunological
products and development pipeline, including Nabi- HB. Nabi Pharmaceuticals
is responsible for the NicVAX(R) (Nicotine Conjugate Vaccine) and StaphVAX(R)
(Staphylococcus aureus Polysaccharide Conjugate Vaccine) development programs.
For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php.
The company is headquartered in Boca Raton, Florida. For additional information
about Nabi Biopharmaceuticals, please visit our Web site: http://www.nabi.com.
11 - Nabi Biopharmaceuticals
Announces Sale of Nabi Biologics to Biotest AG
Nabi Biopharmaceuticals (Nasdaq: NABI)
announced Tuesday that it has entered into a definitive agreement with
Biotest AG, Dreieich, Germany to sell the Nabi Biologics strategic business
unit (SBU) to Biotest Pharmaceuticals Corporation for $185 million. Biotest
researches and manufactures pharmaceutical, biotherapeutic and diagnostic
products and has more than 1,200 employees worldwide.
Biotest has agreed to acquire the Biologics
SBU's products, including Nabi-HB(R) [Hepatitis B Immune Globulin (Human)],
and other plasma business assets, including Nabi's state-of-the-art plasma
protein production plant, and nine FDA-certified plasma collection centers
across the U.S. The acquisition also will include certain of Nabi's Corporate
Shared Services group assets and the company's Boca Raton, Florida headquarters
and other facilities, as well as the assumption of certain liabilities.
'This agreement definitively puts us on
the final path to a successful outcome of our strategic alternatives process,'
said Dr. Leslie Hudson, Interim President and Chief Executive Officer
of Nabi. 'We feel this transaction not only will realize value for Nabi
shareholders but also will allow us to build on the promise of our Pharmaceuticals
SBU pipeline. I am delighted that after the transaction closes our Nabi
Biologics and Corporate Shared Services employees will have the prospect
of a promising future with Biotest.'
'With the acquisition of Nabi Biologics,
we have found the ideal complement for our European plasma protein business
and have become a global player in the industry,' said Professor Dr. Gregor
Schulz, Chairman of the Management Board of Biotest AG. 'We have an immediate
share in the highly attractive and growing US plasma protein market and
are substantially expanding our capacities, extending our product range
and consolidating our clinical development portfolio.'