For Monday, September 10th
SDVI, CYPW, ZPNW, GLIF, RENG,
CSGH, ENVI, SCYI, OJSY, TARR, XTLB
Our Stocks to Watch today include
Spongetech Delivery Systems (OTCBB: SPNG) PhoneBrasil International
(OTC: PHBR), Signature Devices Inc. (OTC: SDVI), Cyclone Power Technologies
(OTC: CYPW), Zippi Networks Inc. (OTC: ZPNW), Grant Life Sciences
(OTCBB: GLIF), Radial Energy (OTCBB: RENG), China Sun Group (OTCBB:
CSGH), EnviroResolutions (OTC: ENVI), Secretaire Technologies (OTC:
SCYI), OJSys Inc. (OTC: OJSY), Tarragon Corp. (NASD: TARR), XTL
Biopharmaceuticals (NASD: XTLB)
DELIVERY SYSTEMS (OTCBB: SPNG)
“Up 10% in morning trading”
SpongeTech Delivery Systems is a development
stage company which designs, produces, markets and distributes cleaning
products for vehicular use utilizing patented technology relating to sponges
containing hydrophilic (liquid absorbing) foam polyurethane matrices.
The Company's sponges are specially configured with an outer contact layer
and an inner matrix, which is loaded with specially formulated soaps and
wax that are released when the sponge is applied to a surface with minimal
pressure. The Company's products are currently designed specifically for
vehicular cleaning use. However, the Company is exploring the possibility
of using its patented technology for the development of sponges for other
uses, including for use with anti-bacterial, bath and kitchen soaps for
household uses, as well as for use as a children's bath foam sponge.
10 - SpongeTech
Delivery Systems Gets Another $5,000,000 (USD) Sale for Asian Market Showing
Its' Continuous Worldwide Expansion!
SpongeTech Delivery Systems, Inc. (OTCBB:
SPNG) the Company announced today that it has just received a new order
from a South Korean Distributor for 500,000 units of its SpongeTech Car
Care Delivery System product. The total order value on this new distribution
order is over $5,000,000 (USD) and is scheduled for delivery from March
2008 through July 2008 to the company's new Asian distributor in Seoul,
This order, when added to the previous
sales order backlog stated in the company's 10KSB last week, brings the
company's current sales backlog up to approximately $10,552,180.
SpongeTech Delivery Systems' CFO, Steven
Moskowitz commented, "We are happy to be able to announce this new order
for SpongeTech Car Care Delivery Systems products with our new Asian distribution
partner in Seoul, South Korea. This new order effectively doubles our
sales order backlog and demonstrates the rapid growth we are currently
experiencing. Additionally, it further validates our efforts to open new
sales, marketing and distribution channels on a global basis." Mr. Moskowitz
further states, "As we have moved from a development stage company, into
a full production stage company, it has been rewarding to us to see that
our vision and efforts are starting to pay off for us and our investors.
To see the company grow from basically a very small sales base, to a sales
backlog of approximately $10.5M over the course of several months, is
exciting. We are just at the very beginning stages of what we can achieve.
We have dozens of other countries and regions to open up new distribution
channels in, and we are just at the beginning stages of signing new sales
and distribution agreements with domestic distributors and retailers as
well. Additionally, we just launched a new product line in a new vertical
market segment for us, Children's Bath Products, which should also open
up new sales and distribution channels for the company. Stay tuned! Good
things are happening at SpongeTech!"
INC (OTC: PHBR)
PhoneBrasil is an American based company
specializing in Hybrid VoIP, cellular and Broadband & WIFI Technology
in the Latin American market as well as servicing the International Telecommunications
Markets. PhoneBrasil supplies four niche markets: wholesale and retail
markets; calling cards that utilize their traffic and minutes via PHBR
T-1 servers and VoIP boxes. The company offers prepaid VoIP calls & equipment
and remains focused on dominating technological aspects like software,
billing, supply and cost savings for the new VoIP industry.
6 - PhoneBrasil
Announces Pending Telecommunications Agreement with Latin American Government
PhoneBrasil International, Inc. (OTC:
PHBR) Anderson Dias, CEO of PHBR in his letter to shareholders stated:
Dear Fellow Shareholder:
As the CEO of PhoneBrasil International,
Inc. it is with a great deal of pride, enthusiasm, and excitement that
I report to you, for the first time, and I promise not the last time,
of the happenings in your company. I plan to announce the details of an
agreement with a Latin American Government Party on or before September
11th, 2007. PHBR is also planning its move to a higher exchange, preferably
OTCBB or AMEX.
Back on June 20th 2007 I announced, Ã¢€œPhoneBrasil
Receives Certification from Brazilian Government and Transfers/Registers
New Licenses in Record Time.Ã¢€ Management believed that it was of utmost
importance to utilize maximum effort in order to insure that PHBR attained
its stated goals. Through that effort we were able to obtain, in record
time, the issuance of licenses, certifications, and corporate documents
from the Brazilian Government in order to have them registered in the
public company, Ã¢€œPhoneBrasil International, Inc.Ã¢€ Accordingly, many small
& midsized communication companies in Latin America desirous of doing
business in Brazil have chosen, on a fee basis, to do business under PhoneBrasilÃ¢€™s
The fact that Carlos Slim, whose telephone
monopoly in Mexico helped make him the world's richest man, is looking
to the fast-growing Brazilian market to add to his wealth, (http://www.iht.com/articles/2007/08/23/bloomberg/bxslim.php)
reinforces PhoneBrasil's belief that it is in the right place at the right
time to take advantage of the rapid growth in the Latin Telecommunications
The Company has the ability to provide
its customers with up to 900 million minutes of telecommunication per
month through its Miami based offices. At maximum capacity, this would
equate to $160,000,000.00 worth of billing for the minutes & traffic per
month. Moreover, for the twelve month period ending at the end of the
third quarter 2008, the Company projects revenues from its wholesale/retail
activities will reach $140,000,000. PhoneBrasilÃ¢€™s core business alone,
together with existing contracts, on an annualized basis, is expected
to produce an EBITA of $1.70 per share.
Lastly, the signed agreement with CityNet
Wireless, to partner the building of a $1.2 Billion communication platform
in Brazil is the final step in the CompanyÃ¢€™s quest to become a major force
in the South American Telecommunications market.
PhoneBrasil International is in the culmination
of years of effort expended by your management team in developing the
associations necessary to permit PhoneBrasil to experience its rapid growth
rate. Your management teams looks forward with unbridled enthusiasm to
the future for PhoneBrasil and is confident that the high benchmarks set
by management will not only be met but surpassed.
In closing, you can be sure that the established
company policy to keep Shareholders fully apprised will, without fear
of contradiction, be fully and unequivocally adhered to.
DEVICES INC. (OTC: SDVI)
Signature Devices, Inc. (OTC: SDVI) publishes,
creates, develops and manufactures advanced information technologies,
including computer systems, software, and electronic products.
The company also publishes software including
video games, and commercial products. One of the companies technologies
includes a blend of hardware and software for Image generation technology.
Signature Devices, has developed software for the world's leading game
publishers, including Electronic Arts (NASDAQ: ERTS),
Crytek, Expresso Fitness, and SNK Playmore. The company has also developed
embedded systems and electronics for companies such as Pacific Consultants
(now PEMSTAR) for the product Land Warrior.
Based in Silicon Valley, Signature Devices
has created technology for advanced 3D systems for use in gaming systems,
simulations and digital CG films. One of Signature Devices, Inc. core
businesses is to publish and distribute video games. The company
brings high caliber independently developed games to a variety of gaming
platforms, including PC, Playstation 2, Xbox, and Game Boy Advance/Nintendo
DS. Signature Devices, Inc. seeks titles from small and mid-size developers
and will provide complete publishing to get them to market, including
sales, distribution, marketing and public relations.
6 - WallSt.net
(http://www.wallst.net) Updates the
Investment Community Through All-New Interviews with SDVI, FFEX and NSTC
On August 6, Kenneth Hurley, CEO of Signature
Devices, Inc. (OTC: SDVI) (http://www.signaturedevices.com)
updated the investment community in an all-new interview with www.wallst.net.
Interview highlights include detailed discussions on the following topics:
-- target markets for the company's 3-d
-- recent press releases
-- the company's relationship with Global
-- royalty revenue streams, and how they
impact the company's bottom line
-- steps the company has taken to expand
its core business
-- growth strategy for Graffiti Entertainment
-- reasons the company is able to 'acquire
-- upcoming milestones for investors to
To hear the interview in its entirety,
and to read an in-depth report on the company, visit http://www.wallst.net/superstocks/superstocks_profile.asp?ticker=sdvi
About Signature Devices, Inc. and
Graffiti Entertainment, LLC:
Based in Redwood City, Calif., Signature
Devices, Inc. (www.signaturedevices.com)
(OTC: SDVI) creates, develops and manufactures advanced information technology,
including computer systems, software and electronics products. One of
the company's premiere technologies includes a blend of hardware and software
for Image generation technology used in video games and simulations. Graffiti
Entertainment, LLC (www.GraffitiEntertainment.com) is a full-service developer
and publisher of interactive entertainment software for advanced entertainment
consoles. Its focus is on creating, developing, and publishing trend setting
titles with mass-market appeal.
POWER TECHNOLOGIES (OTC: CYPW)
“Up 20% in morning trading”
Cyclone Power Technologies (OTC: CYPW)
holds the U.S. patent, international patent applications, and exclusive
commercial rights to the Green Revolution Engine(tm), an environmentally-friendly
and highly-efficient external combustion, heat-regenerative engine. Developed
Cyclone's President and CEO, Harry Schoell, the Green Revolution Engine(tm)
regenerates (or recycles) its heat, which allows it to run cleaner, cooler
and more efficiently than traditional internal combustion engines. It
is capable of running on any liquid or gaseous fuel, including ethanol
and propane, and is lubricated with de-ionized water instead of motor
oil. By eliminating many subsystems like oil pumps, radiators, catalytic
converters and fuel injectors, Cyclone's Green Revolution Engine(tm) is
expected to cost less to manufacture, operate and maintain; however, it
is highly scalable and sufficiently powerful for applications ranging
from lawn equipment and small home generators, large stand alone generators,
to cars, trucks, buses, RV's, boats and ships, as well as earth moving
equipment and locomotives.
4 - Cyclone Power
Technologies Signs Agreement to Expedite Development of Its Green Engine
Cyclone Power Technologies, Inc. (OTC:CYPW)
announced recently that it has entered into a Technology Development Agreement
with TETRAD Energy Corporation, Inc.
Under the terms of the agreement, TETRAD
shall provide assistance to Cyclone in the late-staged development of
its Green Revolution Engine(tm), including securing the support of scientific
experts, key governmental agencies, independent testing and data-verification
facilities, and private equity financiers. For its services, TETRAD has
been granted a license option, which if exercised, will allow it to manufacture
home and commercial generators up to 15kw in size using Cyclone's external
combustion, heat-regenerative engine technology.
"We are excited to be working with
TETRAD in the late-stage development of our technology," stated Harry
Schoell, Cyclone's CEO and inventor of the technology. "I believe that
TETRAD's expertise will provide great value to our progress."
TETRAD's President and CEO, Carmella Angus,
has over 25 years experience in all phases of product development and
has been a key strategist in the late-phase development and market launch
of several successful products including one pharmaceutical product with
global revenues exceeding $12 billion. TETRAD's CTO, Martin Dudziak PhD,
has worked for over 20 years in both basic and applied R&D within physics
and engineering fields, including the design and delivery of alternative
and conventional energy-based systems for military, medical, security
and emergency applications.
"In my assessment," stated Dr. Dudziak,
"the Cyclone technology is one of the most practical solutions for energy
sustainability and renewability for a society so intensively based upon
powered vehicles for transportation and travel. It is very practical for
the world of 2008 and beyond and is adaptable to the emergence of new
ZIPPI NETWORKS INC. (OTC:
Zippi Networks, Inc., arms a new generation
of online sellers with the advanced tools and strategies to free themselves
from shrinking profits, unnecessary competition, a dwindling number of
unique items to merchandise, and inventory overhead. The industry's first
one-call 1-877-GO-ZIPPI pickup-and-sell service, advanced technology and
a revolutionary business model (patents pending) allow Zippi to simplify
the process so much that anyone can sell online and earn the cash they
deserve. At the same time, professional tools - such as the industry's
first enterprise-level palmtop device for completely integrated anywhere/anytime
online selling - along with a supportive network and infrastructure, simplify
the "leap" to becoming a successful online sales entrepreneur.
28 - Zippi(TM)
Networks Sees 600 Percent Rise in Website Traffic Ranking
Zippi™ Networks, Inc. (OTC: ZPNW),
the innovative force empowering a new generation of online sellers, recently
announced a 600 percent increase in the number of Internet users around
the world who visited http://www.zippi.com over the last three months.
Zippi Networks' public launch occurred in June, which included introduction
of the company’s eye-catching and useful new website.
According to global Internet traffic monitor
Alexa.com, the influx of visitors to the Zippi website has boosted it
to a ranking of 628,061 in the world. Alexa also rated site performance
as “Very Fast” with 86 percent of worldwide web sites ranked
“It's crucial, with Zippi's
transition from development to revenue mode, that word-of-mouth, advertising,
public relations, marketing drive consumers and potential online entrepreneurs
to our very compelling and useful website,” said Zippi Networks
President Dean Rositano, “Such a significant ramping of traffic
is a very encouraging sign visitors are taking interest in the opportunity
to build a home based business of their own, using Zippi's unprecedented
1-877-GO-ZIPPI one-call pickup service, and the benefits and advanced
tools that are part of becoming a commission-based Zippi Affiliate.”
LIFE SCIENCES (OTCBB: GLIF)
“Up 80% in morning trading”
Grant Life Sciences Inc., a development
stage company, engages in the research, development, marketing, and sale
of diagnostic kits for the screening, monitoring, and diagnosis of diseases
with emphasis on women's health, infectious diseases, and cancers.
10 - Grant Life
Sciences Announces That U.S. Patent Will Be Issued for Blood Test That
Detects Cervical Cancer
Grant Life Sciences (OTC Bulletin Board:GLIF)
announced today it has received notice from the U.S. Patent and Trademark
Office that Patent No. 7,267,961--'PEPTIDES FROM THE E7 PROTEIN OF HUMAN
PAPILLOMA VIRUSES 16 AND 18 FOR DETECTING AND/OR DIAGNOSING CERVICAL AND
OTHER HUMAN PAPILLOMA VIRUS ASSOCIATED CANCERS'--will issue tomorrow,
Tuesday, Sept. 11, 2007.
"Of course we are extremely pleased by
the issuance of this patent, which is an important part of a comprehensive
IP portfolio focusing on HPV detection and diagnostic technologies, including
domestic patents, international patents and patent applications, that
Grant Life Sciences is overseeing," said Hun-Chi Lin, Ph.D., Grant's President
and Chief Scientist.
"No doubt, this is a very significant development
for Grant Life Sciences," added Dr. Lin. "This patent would protect our
investment to date in the development of our serum-based test for cervical
cancer and allows us to move forward confidently in seeking an appropriate
In a further development, Pop3 is engaged
in ongoing negotiations to acquire rights to certain technologies, currently
under development, and hopes to be able to issue guidance regarding this
development in the very near future.
ENERGY (OTCBB: RENG)
"Up 44.44% in morning trading"
Radial Energy identifies, acquires, and
develops low risk oil and natural gas exploration and development opportunities
throughout the Americas. The Company's innovative strategy involves targeting
overlooked or under-developed reserves that are under the radar of multinational
oil companies and out of the reach of small independents.
10 - Radial Energy
Announces Letter of Intent to Participate in Ecuadorian Gold Mining Projects
Radial Energy Inc. (OTC BB:RENG) is pleased
to announce that the Company has signed a Letter Of Intent ("LOI") with
Minera Del Pacifico S.A. ("Pacifico") to acquire mining assets located
in the productive gold mining province of El Oro, located in the southern
region of Ecuador. The LOI plans for the acquisition of a 45% ownership
interest in the EMPEC floatation mill and the rights to develop two existing
gold mines. The EMPEC floatation mill also includes the rights to 19 exploration
concessions and is one of the largest floatation mills in Ecuador, with
the ability to produce approximately 250 tons of hard rock per day.
The signing of the LOI reflects the Company's
intent to leverage its Latin American business experience and expertise
to include mining operations in tandem with its ongoing commitment to
oil and gas exploration, in particular to the development of the Huaya
Block in Peru. The Company is currently performing due diligence on the
mining assets and expects to sign a Definitive Agreement with Pacifico
by November 30, 2007. Further information on the development of the mining
assets will be released in the upcoming weeks. Full details of the LOI
can be found in Radial's report on Form 8K to be filled with the Securities
and Exchange Commission ("SEC").
SUN GROUP (OTCBB: CSGH)
"Up 57.14% in morning trading"
China Sun Group High-Tech Co., formerly
known as Capital Resource Funding, produces anode materials used in lithium
ion batteries. Through its majority- owned operating subsidiary, Da Lian
Xin Yang High-Tech Development Co. Ltd ("DLX"), the Company primarily
produces cobaltosic oxide and lithium cobalt oxide. According to the China
Battery Industry Association, DLX has the second largest non-governmental
manufacturer of high-tech cobalt series products in Asia. Through its
R&D group, DLX owns a proprietary series of nanometer technologies
that supply state-of-the-art components for advanced lithium ion batteries.
Leveraging its technological leadership in China, high-quality product
line and scalable production capacity, DLX plans to create a fully integrated
supply chain from the primary manufacturing of cobalt ore to finished
products, including lithium ion batteries. For more information, visit
6 - China Sun
Group Reports Strong Revenues of $8.3 Million and Achieves Profitability
in Fiscal 2007
China Sun Group High-Tech Co., (OTC Bulletin
Board:CSGH; "China Sun"), formerly known as Capital Resource
Funding Corp., announced today its audited financial results for the fiscal
year ended May 31, 2007. All results presented herein are represented
in U.S. Dollars. Full details are available on Form 10-KSB filed at http://www.sec.gov.
"I enthusiastically report that in our
first year of operations we achieved impressive revenue growth and profitability,"
said Bin Wang, CEO of China Sun Group. "In April 2006, our subsidiary
DLX commenced production and quickly amassed sales of over $1.5 million.
Our strong performance in fiscal 2007 indicates we can continue to drive
sales momentum by servicing manufacturers with the highest quality components
for lithium ion battery circuitry."
Revenues for the year ended May 31, 2007
totaled $8,275,066 compared to $277,715 for the year ended May 31, 2006,
an increase of $7,997,351. The increase resulted from new sources of sales
channels and market demand from business development of new customer.
Cost of revenues for the year ended May 31, 2007 totaled $4,758,023 compared
to $Nil for the year ended May 31, 2006. General and administrative expense
for the year ended May 31, 2007 totaled $1,247,533 compared to $163,341
for the year ended May 31, 2006, an increase of $1,084,192. The increase
resulted from the allowance of a doubtful account of $777,831 and the
overhead for a new office setup in the United States.
Research and development expense for the
year ended May 31, 2007 totaled $89,166 compared to $83,000 for the year
ended May 31, 2006, an increase of $6,166. The increase resulted from
the continuous development of new products and advancement of manufacturing
Income from operations for the year ended
May 31, 2007 totaled $1,400,185 compared to a loss from operations of
$343,950 for the year ended May 31, 2006, an increase of $1,744,135. The
increase resulted from growth in sales. During the years ended May 31,
2007 and 2006, net cash used for operating activities was $730,162 and
$651,081, respectively. During fiscal 2007, operating funds were primarily
used for working capital and increase the balance of trade accounts receivable.
"Up 39.20% in morning trading"
EcoGen designs and produces environmental
control systems and equipment for the North American market. This merger
allows us to proceed with the manufacture of our patented bubble scrubber
which removes sulphur dioxide, nitrogen oxide, and particulate from the
exhaust of diesel engines. We are presently building a website at enviroresolutions.com
for more detailed information. EcoGen was incorporated in 2001 with a
mission to become a global supplier of innovative pollution control systems
10 - EnviroResolutions,
Inc. Announces Merger with EcoGen Power Corporation
EnviroResolutions, Inc. ("EnviroResolutions"),
a publicly traded company on the Pink Sheets: trading symbol: ENVI.PK,
is pleased to announce that it has signed a definitive Share Exchange
Agreement with EcoGen Power Corporation ("EcoGen").
INDUSTRIES (OTC: SCYI)
"Up 37.25% in morning trading"
7 - Secretaire
Industries Inc. Signs LOI with Free-Market News Network to Effect a Business
Secretaire Industries Inc. (scyi) and Free-Market
News Network, Corp. are pleased to jointly announce the commencement of
formal negotiations to effect a business combination.
The proposed combination may be effected
in one of several different ways, including an asset acquisition, merger
of Free-Market News Network, Corp. (FMNN) and Secretaire Industries, or
a share-exchange whereby Secretaire purchases the shares of FMNN from
its shareholders in exchange for shares of Secretaire. Both parties will
jointly determine the optimum structure for the transaction in order to
best satisfy tax planning, regulatory and other considerations, including
mutually agreed upon performance based milestones.
"We are excited about the potential
to acquire a fast-growing and dynamic company that appears to be well
positioned to benefit from the major societal shift from traditional media
outlets to alternative 'net providers," commented Randy Schuler, President
Mr. Schuler continued, "FMNN is a leading
provider of social, political and financial news and information, albeit
presented from a free market oriented point of view. We believe the positive
growth of such free market thinking is likely to continue, with resultant
INC. (OTC: OJSY)
"Up 45.56% in morning trading"
OJsys, Inc. (OJSY), established in April
of 2000, develops and manufactures various broadcasting receivers/Set-top
Boxes, i.e. satellite receiver, terrestrial receiver, IP set-top boxes,
receiver-plus-DVD-RW combos, etc., and media center PC devices including
satellite receivers and digital recording (PVR) functions. OJsys markets
its products to Europe, Japan, the Middle East, Asia and the United States.
More information is available at www.OJsys.net.
10 - OJsys, Inc.
Successfully Completes Product Development With Samsung Electronics
OJsys, Inc. (OTC:OJSY) announced today
that its wholly owned NTN, Inc. subsidiary successfully completed its
co-development with Samsung Electronics Co., Ltd., a world leader in digital
technology, of operating software for Samsung's digital camera.
The newly developed software gives the
digital camera a scroll menu, multi-layered picture viewing, and the ability
to edit moving pictures. The digital camera operating software joins OJSY's
Satellite TV set-top box as the second product co-designed by OJsys and
Samsung, based in Korea, is one of the
largest electronics companies in the world, and is a leader in digital
convergence. Samsung's products include mobile phones, home entertainment
devices, home appliances, computer devices and more. Their annual revenue
is in the tens of billions of dollars, with 75,000 employees and a sales
network covering more than 47 countries.
Henri Joubaud, CEO of OJsys, said, "We
are excited that Samsung chose OJsys to help develop this software. We
are being rewarded for the consistent development of our technology and
attention to detail. We look forward to more development deals with Samsung
and other electronics manufacturers in the future."
CORP (NASD: TARR)
"Up 6.56% in morning trading"
Tarragon Corporation is a leading developer
of multifamily housing for rent and for sale. Tarragon's operations are
concentrated in the Northeast, Florida, Texas and Tennessee. To learn
more about Tarragon Corporation, visit: www.tarragoncorp.com.
7 - Tarragon Corporation
Closes $69.25 Million Property Sale and Reaches Understanding With Largest
Creditor for Reinstatement of Over $550 Million of Loans
Tarragon Corporation (NasdaqGS:TARR) recently
announced that it has closed the sales of two of its Florida rental properties
for $69.25 million and that it has reached agreement with its largest
creditor, General Electric Capital Corporation (GECC), on the terms, which
Tarragon expects to be satisfied early next week, under which GECC will
reinstate all loans that it has made to Tarragon and/or its affiliates.
The proceeds from the sale of the two Florida
properties have allowed Tarragon to satisfy approximately $50 million
of outstanding indebtedness, bring current all debt service that had been
owed to GECC and to establish certain cash and other reserves. Further,
in addition to the property sales announced today, Tarragon also has accepted
offers or entered into contracts to sell additional properties in Florida
and Tennessee over the next 30 days. Such sales, if completed, would generate
approximately $35 million in net proceeds while reducing Tarragon's outstanding
debt by about $270 million.
The Florida property sales, agreement
with GECC and the above-referenced property sales are part of an overall
Tarragon plan designed to restore liquidity and improve its financial
condition. As part of this plan, Tarragon is in discussions with other
significant lenders. As described above, the plan currently contemplates
additional property sales, the proceeds of which would be used to repay
or bring current Tarragon's obligations under other loan agreements and
to provide Tarragon with additional liquidity.
There can be no assurance, however, that
the contemplated property sales will be completed on acceptable terms
or in a timely manner, that Tarragon will complete its agreement with
GECC or that it will be able to reach agreements with other lenders. If
not, it may be necessary for Tarragon to undertake such other actions
as may be appropriate in the light of its current liquidity situation.
BIOPHARMACEUTICALS (NASD: XTLB)
"Up 33.33% in morning trading"
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) today 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.