dallas tx 8/14/2009 12:44:50 AM
News / Business

OPSY, SNEY, NVSR, YASH, GSAE, ATNO, SEWC, CIRC, CEGE, BPAX, HTDS OTCPicks.com Daily Market Movers Digest Midday Report for Thursday, August 13th

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Our Stocks to Watch today include Optical Systems Inc. (OTC: OPSY), Sunergy Inc. (OTCBB: SNEY), NavStar Technologies Inc. (OTC: NVSR), Yasheng ECO-Trade Corp. (OTCBB: YASH), Green Star Alternative Energy Inc. (OTC: GSAE), Atlantis Technology Group Inc. (OTC: ATNO), Sew Cal Logo Inc. (OTCBB: SEWC), CirTran Corp. (OTCBB: CIRC), Ceregene Inc. (Nasdaq: CEGE), BioSante Pharmaceuticals Inc. (Nasdaq: BPAX) and Hard to Treat Diseases Inc. (OTC: HTDS).

 

Visit http://www.otcpicks.com/microcap.htm to register for our Daily Market Mover’s Digest Newsletter and Email Stock Watch Alerts.

 

OPTICAL SYSTEMS INCORPORATED (OTC: OPSY)

"Up 30.77% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/OPSY.php 

 

Company Profile: http://www.otcpicks.com/optical-systems/optical-systems.htm

 

Optical Systems, Inc., through its operating subsidiary, Automotive Software Designers, Inc., develops technology and services for the automotive retail industry designed to maximize productivity and increase profits at auto dealerships. ASDI's flagship technology solution, Save-a-Deal, is a turnkey customer relationship management (CRM) tool for auto dealerships. Our business development center (BDC) provides a variety of services designed to help auto dealerships drive traffic to their showroom or Web site, retain customers and generate new streams of revenue.

 

OPSY News:

 

August 12 - DealerDX Selects Save-a-Deal as CRM Software of Choice to Market to More than 650 Minority Dealerships

 

Automotive Software Designers, Inc., a leading provider of software and services for the automotive retail industry, and a wholly owned subsidiary of Optical Systems, Inc. (OTC: OPSY), announced that its flagship software product, Save-a-Deal has been selected by DealerDX, LLC, a private consulting firm and member of the National Association of Minority Automobile Dealers (NAMAD).

 

"Our relationship with DealerDX has the potential to generate $10 million in new business over the next 18 months," said B.J. Grisaffi, Chairman and Chief Executive Officer of Optical Systems, Inc. "DealerDX has relationships with 650 minority dealerships that could all benefit from our software and services. This is a fantastic situation for our company, our customers and our shareholders. We are excited about adding NAMAD to our fast growing dealer network. We now believe our goal of adding 2000 dealers over the next 24 months is achievable and revenues could exceed $100 million with all of our ancillary products."

 

There were approximately 1,200 minority dealerships in the United States in 2007, according to the NAMAD Web site.

 

"Minority dealerships cannot afford to lose deals in today's market," said Lee Putney, President and Founder of DealerDX, LLC. "ASDI's software and services have a proven track record of generating revenue and traffic for dealerships across the United States."

 

ASDI's software and services have been shown to:

 

* Save between 10 and 12 deals per-month

* Increase sales traffic by 15 percent

* Increase service traffic by 28 percent

 

ASDI-DealerDX will offer minority dealerships a full suite of products and services at special association prices with added incentives for each dealership over 100. The company also plans to offer a 40 percent discount when 50 or more dealerships commit to the ASDI-DealerDX program in the first phase. The packages will include Save-a-Deal, Save-a-Car and our comprehensive Sales Manager and Service Manager BDC programs.

 

Save-a-Deal is a comprehensive, fully-integrated front office software solution specifically designed to increase auto dealerships' profitability. When properly used, this scalable DMS system is guaranteed to increase unit sales and profit per vehicle while lowering costs through enhanced efficiency.

 

Save-a-Car is a cost-effective, global positioning system for auto dealerships to monitor and track inventory. In addition to offering superior tracking capabilities over competing solutions, Save-a-Car allows drivers to save up to 35 percent on their insurance premium when installed.

 

SUNERGY INCORPORATED (OTCBB: SNEY)

 

Detailed Quote: http://www.otcpicks.com/quotes/SNEY.php 

 

Company Profile: http://www.otcpicks.com/sunergy-inc/sunergy-inc.htm

 

The Company is an aggressive junior mining exploration and development Company that is production oriented at the earliest possible profitable opportunity. We control 100% of the 150 SQ. Km. Nyinahin mining concession with a full prospecting license. The concession is surrounded by several operating mines and is adjacent to Newmont Mining's property. This concession has the Ofin river flowing through our eastern portion and there are numerous artisan pits ready for testing and evaluation for near term production. The Ofin river is known for good alluvial gold production. Artisans usually recover about 30% of the available gold through primitive hand methods, leaving 60-70% to be recovered by modern mechanical operations.

 

SNEY News:

 

August 13 - Sunergy Reports Update on Operations on Its 150 sq. km. Ghana Mining Concession

 

Sunergy Inc. (OTCBB: SNEY) (the "Company") reports the following update on the planning and preparation for operations on our 150 sq. km. Nyinahin mining concession, located in Ghana, West Africa. During Q'4 2009 we plan to test and evaluate the alluvial gold recovery potential along the Ofin River which runs through the eastern portion of the concession for about 45 km. We plan to do this by bulk sampling the numerous existing artisan pits along the river on our concession. Our planned budget is around $300,000.00 US which could recover an estimated 1,000 oz./gold generating around $900,000.00 of revenue from the program. Our plan involves either leasing a suitable gold recovery plant or joint venturing with another operator with suitable equipment. The permitting for the operation will commence shortly.

 

The Ofin River is an easterly-flowing waterway in Ghana. It flows through the Tano Ofin Reserve in Ghana's Atwima District. The Ofin riverbed is 90 meters above mean sea level. The Ofin and the Pra rivers form the boundary between Ghana's Asahanti and central regions. Dunkwa-on-Ofin is a major town on the river. Gold is mined from the river's sediment. The Ofin tributaries also offer good gold and diamond recovery historically.

 

Karl Baum, Manager of West African Development, said, "Since this concession already has a full prospecting license, permitting is very straight forward and inexpensive. The artisan pits have no overburden and are considered high grade targets by the industry in Ghana. Many alluvial projects in Ghana have from 2-15 meters of overburden, so our excavation costs should be very economic. I am excited about the opportunity for early cash flow."

 

Company President Joseph Guerrero said: "This cornerstone project offers both immediate gold recovery opportunities through the numerous abandoned Artisan pits along the Ofin River as well as substantial hard rock exploration in three large anomalies that warrant a vigorous exploration effort. Some larger mining Companies operating in the area have already expressed interest in evaluating the mineral potential on this concession and we are currently evaluating 2 immediate gold production acquisition opportunities to establish immediate cash flow and aggressively advance our shareholder value."

 

August 12 - Sunergy Appoints Karl A. Baum Manager of West African Business Development

 

Sunergy, Inc. (OTCBB: SNEY) (the "Company") announced the appointment of Mr. Karl A. Baum as Manager of West African Business Development to further advance the Company's Nyanhin Project within the Republic of Ghana and other business and mining interests in the region.

 

Mr. Baum brings with him a background in Business Management from Arizona State University and International Management Studies from Thunderbird School of Global Management. He has over 5 years of experience within West Africa serving as the General Manager for (2) small-scale exploration and gold mining operations within The Republic of Ghana with 7,000 ton/day capacity. As International Procurements and Logistics Manager he has overseen the shipment of over USD 15 Million worth of capital equipment from the United States and imported into Ghana. He has led the permitting activities for the operating mines in Ghana and enjoys a good working relationship with the local and national authorities. Prior to his positions within Ghana, Mr. Baum served as Permitting Coordinator on several gold mining projects in Colorado working with the EPA and Division of Minerals and Geology to ensure regulatory compliance.

 

Mr. Baum has also provided assistance in developing several large scale contracts for mining services within The Republic of Liberia and Sierra Leone; giving him a working knowledge of the customs and concerns of performing within the West African business climate. This hands on experience within the region has assisted him in providing turn-key supply chain management solutions which are vital to successful operations in this part of the world.

 

Karl commented, "I am excited to join the Sunergy family because we share the same vision and goals for developing a large diversified Company throughout West Africa. This economic downturn has uncovered several opportunities that are available now for those ready to do business in Ghana and West Africa. I will return to Ghana shortly and start implementing our business plan for near term gold production and cash flow and keep my eyes open for opportunities."

 

Company Chairman P.K. Rana Medhi said, "We now have an area manager with local knowledge and substantial connections in Ghana. With our debt settled, we are now in position to begin work in earnest on our 150 sq. km. Nyinahin mining concession and Karl is the perfect manager to take us through permitting to production."

 

President Joseph Guerrero commented, "Our aggressive approach to developing our projects and evaluating expansion projects can now proceed rapidly. With Karl's assistance and leadership, we are committed to building a diverse revenue base taking advantage of the business opportunities that Ghana offers."

 

NAVSTAR TECHNOLOGIES INCORPORATED (OTC: NVSR)

 

Detailed Quote: http://www.otcpicks.com/quotes/NVSR.php 

 

Company Profile: http://www.otcpicks.com/navstar-technologies/navstar-technologies.htm

 

NavStar is focused on the creation of GPS products and services that provide wireless tracking of vehicles, equipment, and other valuable and personal assets. The goal is to be a total solutions provider.

 

NVSR News:

 

August 12 - NavStar Shareholder Update: Potential Revenue From Current Agreements Exceed $100M Over the Next 24 to 36 Months

 

NavStar Technologies, Inc. (OTC: NVSR), a multinational firm focused on developing and commercializing asset tracking and monitoring devices for vehicles and high value cargo, released the following shareholder letter.

 

Dear Shareholders,

 

We continue to make significant progress on the customer front and have completed several distribution agreements with partners to represent NavStar in 5 different countries. The typical cycle for us to secure a distribution partner and to recognize revenue is:

 

1) Sales lead

2) Confirm Interest, validate opportunity and access scope

3) Field Trial

4) LOI

5) Business and/or Distribution Agreement

6) Field Trial

7) Technology integration (wireless interface, software customization)

8) Secure PO

 

This process takes time and the speed at which we proceed through this cycle has been lengthened by the current economic climate. In spite of these conditions we have been successful with the customers listed below. Every announcement we have made is a valid customer relationship and valid revenue opportunity.

 

We are working on several additional customer opportunities that will be announced later this month.

 

We are as anxious as you are to report real revenue and to see the stock price reflect the true value of our company. We expect the initial PO from Ecuador either this month or early next month as the field trial is completed. Revenue in 2009 should be between $2.0 and $5.0M.

 

NavStar is still seeking $2.0M to $3.0M in longer term financing. We are approaching this fund raising on several fronts and remain optimistic that significant funding will be available in the next several months.

 

In the coming weeks our press releases will consist of topics relative to NavStar Technologies' previously mentioned negotiations, our funding efforts and more details about our plans for 2009 and beyond. We do listen to our shareholders, and are working hard to build value for you and for NavStar.

 

Sincerely,

 

N. Douglas Pritt

Chairman & CEO

NavStar Technologies, Inc.

 

YASHENG ECO-TRADE CORPORATION (OTCBB: YASH)

 

Detailed Quote: http://www.otcpicks.com/quotes/YASH.php 

 

Company Profile: http://www.otcpicks.com/yasheng-eco-trade.htm

 

The Company's business is the identification and acquisition of undervalued assets within emerging industries for the purpose of consolidation and development of these businesses and sale if favorable market conditions exist. The Company's competencies include financial services, mergers and acquisitions, accounting, real estate development and natural resources exploration. The Company is currently in the process of developing a logistics center. As part of its strategy to develop a logistics center, the Company has entered a term sheet with Yasheng Group in which Yasheng Group, among other things, has agreed to contribute real property for the development of a logistics center.

 

YASH News:

 

August 10 - Yasheng ECO-Trade Corporation Provides Corporate Update

 

The Board of Directors for Yasheng ECO-Trade Corporation (OTCBB: YASH) recently provided a corporate update on the Company’s activities relating to the development of a trade zone and certain potential Merger and Acquisition (M&A) activity. Following the company’s signing of their initial term sheet with Yasheng Group on January 26, 2009 (the “Yasheng Group Transaction”) the Company has been actively working to position and maximize the opportunities associated with the Yasheng Group Transaction.

 

The first component of the Yasheng Group Transaction involves the establishment of the Yasheng Asian Pacific Cooperative Zone (the "Cooperative Zone"). The Cooperative Zone will be located in Southern California, in a big box building – as a free zone facility – which will provide logistics, distribution, customer service, sales marketing and quality control headquarters for designated Chinese companies. Since signing the agreement in January, the Company engaged Colliers International to locate and negotiate a long term lease for a big-box-building. In addition, the Company has engaged Legend Transportation and Better Online Solutions to consult the Company regarding RFID tracking, Logistics Coordination and shipping. The Cooperative Zone will be a free zone big box (e.g. merchandize entering the US into this building will not need to clear customs, until shipped outside the building to the end user) storing massive merchandize under one roof from China. This concept will allow the Cooperative Zone to handle all paperwork associated with Export/Import, as well as vacate the needs of local US clients to import big quantities of goods, and therefore better manage their inventory turnover, as well as optimize the needs for working capital.

 

The second component of the Yasheng Group Transaction involves the potential merger or acquisition of the Yasheng Group and other Chinese companies into the Company. In addition to the transaction with Yasheng Group, the Company has recently also signed a binding term sheet with Zangye Golden Dragon. The Zangye Golden Dragon proposed transaction was introduced to the Company by the Yasheng Group. The acquisition of Yasheng Group or other Chinese entities is subject to the drafting and negotiation of final definitive agreements, performing due diligence as well as board approval of the Company. As such, there is no guarantee that the Company will be able to successfully move forward with such acquisitions.

 

Finally, the transaction has evolved to include the establishment of a Joint Venture to expand the opportunities for both the Company and Yasheng. This transaction includes the establishment of Yasheng Russia, which will focus on the development of a Stock Breeding Farm. The joint venture is subject to the drafting and negotiation of a final definitive agreement, performing due diligence as well as board approval of the Company. As such, there is no guarantee that the Company will be able to successfully move forward with such joint venture.

 

Yasheng ECO-Trade Chairman Greg Rubin commented, “The Board is pleased with the progress the company has made and is encouraged by the companies’ plans for the future.”

 

GREEN STAR ALTERNATIVE ENERGY INCORPORATED (OTC: GSAE)

 

Detailed Quote: www.otcpicks.com/quotes/GSAE.php 

 

Company Profile: http://www.otcpicks.com/Newsletter/GSAE_eProfile_091708.htm  

 

Green Star Alternative Energy is an environmentally conscious, renewable energy producer. The Company is working to develop more than 300 MW (megawatts) of clean electricity through wind energy. The corporate revenue model is two-fold: the use of a renewable resource allows not only for the creation of environmentally friendly energy, but the granting of carbon (greenhouse gas) emission credits which may be traded and sold. Green Star is pursuing a significant opportunity to provide clean energy to the growing Republic of Serbia and neighbouring European countries. Through a joint venture with key wind farm and power trading company Notos, Green Star will become the nation's first developer of wind power. GSAE is focussed on green technology and sustainable energy programs like wind turbines, hydro electric power generation, and other renewable electricity models.

 

GSAE News:

 

August 11 - CEO of Green Star Alternative Energy Conducts Exclusive Webcast Interview with The Green Baron Report

 

Green Star Alternative Energy, Inc. (OTC: GSAE) ("GSAE" or the "Company") announces that its CEO Mike Andric has conducted an exclusive new audio-taped webcast interview so that GSAE shareholders and the investment community can learn more about the Company’s recent developments and growth plans. Unrestricted access to the webcast is now available on the “Webcasts” page at www.TheGreenBaron.com. This webcast is also available at www.StrictlyStocks.com, "Where Wall Street speaks to the World."

 

The Green Baron Report also issued a new “Stock Pick” profile dated Tuesday, August 4th, 2009 to its members and is available on their website. The report focused on how Green Star is moving forward to develop wind energy projects to the under supplied market in Serbia. The report also detailed how its Joint Venture with Notos, a private Serbian company dedicated to renewable energy, enables Green Star to establish a leadership role in the development and supply of wind power in Serbia and the Balkan Peninsula.

 

ATLANTIS TECHNOLOGY GROUP (OTCBB: ATNO)

"Up 60.87% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/ATNO.php

 

Atlantis Business Development Corporation operates as a business development company that primarily assists eligible portfolio companies with capital information. The company was incorporated in 1986 as Vision Technology International and changed its name to Medplus Corporation in 1992. Subsequently, it changed its name to Atlantis Business Development Corporation in 2003. Atlantis Business Development Corporation is headquartered in Miami, Florida.

 

ATNO News:

 

August 12 - Atlantis Technology Group's Subsidiary Global Online Television Announces Projected Sales Revenues Over $50 Million

 

Atlantis Technology Group (OTC: ATNO) subsidiary Global Online Television Corporation (GOTV) announces projected sales revenues of the GOTV service of over $50 Million US by year end 2010. This projected sales revenue was based on marketing research of the IPTV products offered by GOTV. The projected customer base exceeds 100,000 subscribers by year end 2010. This sales projection does not include the GO-V-Phone service soon to be offered.

 

IPTV statistics from RNCOS.com: "The Worldwide IPTV subscribers are forecasted to reach to 103 Million in 2011. Americas and Western Europe are expected to be the biggest markets on revenue per user basis. The worldwide IPTV Service Revenue is forecasted to reach US $38 billion and subscribers are forecasted to reach 53 million in the year 2009."

 

ABOUT GLOBAL ONLINE TELEVISION

 

Global Online Television Corporation was originally developed by Atlantis Technology Group as a media division that would explore and further media-based technology. GOTV brings the largest internet protocol television networks together for your home television viewing. IPTV is TV to TV using standard broadband connections, thus making it possible for 93% of the world's broadband users to relieve its streams. Using the IPTV and Microsoft Windows Media Player, the video stream is delivered to your home television over any broadband internet connection. This means that if you already have a connection, like DSL or cable modem, then you're ready to go.

 

Atlantis Technology Group's Board of Directors Approves a Forward Split of 1 for 5

 

Atlantis Technology Group (OTC: ATNO) Board of Directors approved a forward split 1 for 5 at a special Board of Directors meeting on August 11th, 2009, for every 1 share of Atlantis the shareholders will receive an additional 5 shares of Atlantis. This split was agreed unanimously by the Board of Directors.

 

The Board of Directors feels this forward split will give opportunity for investors to become shareholders of Atlantis Technology Group as well as give current shareholders more value in Atlantis Technology Group .The Board of Directors has scheduled a special meeting for August 15, 2009 to discuss details of the forward split.

 

SEW CAL LOGO INCORPORATED (OTCBB: SEWC)

"Up 200.00% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/SEWC.php

 

Sew Cal Logo, Inc. produces and manufactures custom embroidered caps, sportswear, and related corporate identification apparel primarily in the United States. It offers caps and headwear, jackets, denim, cargo shorts, pants, and related apparel. The company also provides contract embroidery and silk-screening services to the manufacturing and promotional industry; and designs and manufactures apparel under private labels. In addition, it supplies wardrobe, as well as promotional and cast and crew items for feature films and television. Further, Sew Cal Logo owns the rights to a branded line of surf and sports wear items known as Pipeline Posse, which it sells primarily through the Internet. It sells its products to motion picture and television studios, retailers, local schools, shops, and small businesses. The company was founded in 1985 and is based in Los Angeles, California.

 

SEWC News:

 

June 9 - Sew Cal Logo Reports Earnings

 

Visit http://bit.ly/J53U9 to view the most recent quarterly financial report for Sew Cal Logo Inc. (OTCBB: SEWC).

 

CIRTRAN CORPORATION (OTCBB: CIRC)

"Up 30.53% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/CIRC.php

 

Founded in 1993, CirTran Corporation has evolved from its roots as a premier international, full-service contract manufacturer. From its headquarters in Salt Lake City, where it operates along with its Racore Technology electronics manufacturing subsidiary from an ISO 9001:2000-certified facility, CirTran has grown in scope and geography. Today, CirTran’s operations include: CirTran-Asia, a subsidiary with principal offices in ShenZhen, China, which manufactures high-volume electronics, fitness equipment, and household products for the multi-billion-dollar direct response industry; CirTran Online, which offers products directly to consumers through major retail web sites, and CirTran Beverage, which has partnered with Play Beverages, LLC to introduce and distribute the Playboy Energy Drink.

 

CIRC News:

 

June 1 - CirTran Opens Door to Eastern Europe for Playboy Energy Drink With 5-Year Distribution Agreement in Albania

 

CirTran Corporation (OTCBB: CIRC) announced that it has again added to the international distribution of the new line of Playboy-branded energy drinks it manufactures and distributes, signing a five-year agreement giving rights in Albania to the Tobacco Holding Group Sh.p.k, an Albanian company based in Tirana.

 

Under the terms of the agreement, the Tobacco Holding Group gains exclusive rights to distribute Playboy Energy Drink in Albania. Concurrent with signing the agreement, Tobacco Holding placed and paid for an initial order with CirTran Beverage Corp, a wholly-owned subsidiary of CirTran Corporation which spearheads the manufacture and distribution of Playboy Energy Drink and Playboy Energy Drink Low Sugar.

 

Playboy Energy Drink was formally introduced in the U.S. by CirTran a year ago, and is gaining in its popularity in the U.S. and abroad, said Iehab J. Hawatmeh, founder, president and CEO of CirTran.

 

Opening the Door to Eastern Europe

 

Mr. Hawatmeh said that the signing of the agreement with the Tobacco Holding Group “opens the door to Eastern Europe for our exciting new product.” He said that approval for distribution in Albania has already been gained, and that product has been shipped.

 

“CirTran is very excited about how our Playboy Energy Drink has been received in the U.S. and around the world,” Mr. Hawatmeh said, noting that late last year CirTran signed a 10-year agreement in Mexico.

 

“Consumers, retailers and the beverage distribution community around the world have shown great interest in the Playboy Energy Drink,” he said. “And now, with the door open to Eastern Europe, CirTran will be working to increase distribution in marketplaces where the Playboy name is already well known.”

 

Lirim Fezollari, managing director of the Tobacco Holding Group, said his company “is very excited about bringing this great brand and product to our country. We are confident of its immediate popularity,” he said.

 

CELL GENESYS INCORPORATED (NASDAQ: CEGE)

"Up 38.42% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/CEGE.php

 

Cell Genesys, Inc., a biotechnology company, engages in the development and commercialization of biological therapies for patients with cancer. It develops cell-based cancer immunotherapies and oncolytic virus therapies. The company's GVAX cancer Immunotherapies comprise Prostate Cancer, a phase III product for the treatment of prostate cancer; Pancreatic Cancer, a phase II product for pancreatic cancer; and Leukemia, a phase II product for the treatment of acute and chronic myelogenous leukemia, and myelodysplastic syndrome. Its Oncolytic Virus Therapy includes CG0070, a phase I product for the treatment of recurrent bladder cancer. Cell Genesys has alliance with Novartis AG for the development and commercialization of oncolytic virus therapies; research and development collaboration with Medarex, Inc.; and development and commercialization collaboration of GVAX immunotherapy with Takeda Pharmaceutical Company Limited for prostate cancer. The company was founded in 1988 and is headquartered in South San Francisco, California.

 

CEGE News:

 

August 5 - Ceregene Receives Additional Grant From Michael J. Fox Foundation to Expand Long-Term Testing of CERE-120 Patients

 

Ceregene, Inc. (Nasdaq: CEGE) announced that the Michael J. Fox Foundation will provide partial funds for long-term follow-up testing of patients enrolled in the company's Phase 2 trial of CERE-120 for Parkinson's disease. The funding will enable Ceregene to collect and analyze more extensive data for up to 48 months from patients with advanced Parkinson's disease who were enrolled in the double-blind, controlled trial which ended in November 2008.

 

As was previously announced, the Phase 2 trial of CERE-120 involving 52 patients, failed to demonstrate a difference in the primary endpoint between patients in the CERE-120 versus control group. It was subsequently announced, however, that CERE-120 suggested improvement on several secondary endpoints at 12 months, and at 18 months, a statistically significant treatment effect on the primary endpoint emerged, while several additional secondary endpoints also showed improvement. In contrast, on no measure did sham patients perform better than CERE-120 patients, at either 12 or 18 months. Based on those findings, and insight gained from analyses of post-mortem brain tissue from two CERE-120 treated patients, the company has revised the dosing regimen and expects to initiate a new trial of CERE-120 in the near future.

 

"We are pleased to be able to gather unique, long-term data from both CERE-120 treated and control patients and thus gain more information about the potential long-term effects of CERE-120 on Parkinson's disease," stated Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer. "We very much appreciate the support the MJFF has provided to enable us to expand the testing of these patients and further enrich our data base. Our conviction about CERE-120's potential to treat Parkinson's disease remains strong. We learned a significant amount from the initial Phase 2 trial which enabled us to design a protocol that should maximize the potential for the greatest treatment effect in our upcoming Phase 2 trial."

 

Phase 2 Trial of CERE-120

 

Ceregene's Phase 2 trial was a double-blind, controlled clinical trial that completed enrollment of 58 patients with advanced Parkinson's disease in October 2007. Patients in the Phase 2 trial were enrolled across nine leading academic medical centers in the United States, with two thirds of patients receiving CERE-120 and one third enrolled into a control group. Patients received a single administration of CERE-120 via stereotactic neurosurgery to deliver the drug into the putamen region of the brain and were followed for a minimum of 12 months for safety and efficacy, with over half the subjects followed for 15 to 18 months under blinded conditions, allowing longer-term analyses of the therapeutic effects of CERE-120.

 

CERE-120 and its Application to Treating Parkinson's Disease

 

CERE-120 is composed of an adeno-associated virus (AAV) vector carrying the gene for neurturin, a naturally occurring protein known to repair damaged and dying dopamine-secreting neurons, keeping them alive and restoring normal function. Neurturin is a member of the same protein family as glial cell-derived neurotrophic factor (GDNF). The two molecules have similar pharmacological properties, and both have been shown to benefit the midbrain dopamine neurons that degenerate in Parkinson's disease. Degeneration of these neurons is responsible for the major motor impairments of Parkinson's disease. CERE-120 has been delivered by stereotactic injection to the terminal fields (i.e., the ends of the degenerating neurons), located in an area of the brain called the putamen. The cell bodies for these same neurons are located in a different area of the brain, called the substantia nigra. Once CERE-120 is delivered to the brain, it provides stable, long-lasting expression of neurturin in a highly targeted fashion. Genzyme Corporation (Nasdaq: GENZ - News) has licensed the ex-North American rights for the development and commercialization of CERE-120 from Ceregene, an agreement that was announced in June 2007.

 

ABOUT PARKINSON'S DISEASE

 

Parkinson's disease is a progressive movement disorder that affects a million people in the United States. Its main symptoms, stiffness, tremors and slowed movements and gait, are caused by a loss of dopamine-containing nerve cells in the substantia nigra, which project their axons to the putamen. Dopamine is a neurotransmitter involved in controlling movement and coordination, so Parkinson's patients exhibit a progressive inability to initiate and control physical movements. There is currently no treatment that can reverse the degeneration of these neurons, let alone cure Parkinson's disease.

 

ABOUT THE MICHAEL J. FOX FOUNDATION

 

The Michael J. Fox Foundation is dedicated to ensuring the development of better treatments, and ultimately a cure, for Parkinson's disease through an aggressively funded research agenda. MJFF has funded $149 million in research to date.

 

ABOUT CEREGENE

 

Ceregene, Inc. is a San Diego-based biotechnology company focused on the delivery of nervous system growth (neurotrophic) factors for the treatment of neurodegenerative and retinal disorders using gene delivery. Ceregene's clinical programs include CERE-110, an AAV2 based vector expressing nerve growth factor that is currently in a multi-center, controlled Phase 2 study for the treatment of Alzheimer's disease, and CERE-120 (AAV2-Neurturin) for Parkinson's disease. CERE-135 and CERE-140 are in preclinical development for ALS (Lou Gehrig's disease) and ocular disorders, respectively. Ceregene was launched in January 2001. The company's investors include Alta Partners, MPM Capital, Investor Growth Capital and Cell Genesys, Inc. (Nasdaq: CEGE) as well as Hamilton BioVentures and California Technology Partners.

 

BIOSANTE PHARMACEUTICALS INCORPORATED (NASDAQ: BPAX)

"Up 30.34% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/BPAX.php

 

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante's lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3.0 billion. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook™). Additional information is available online at www.biosantepharma.com.

 

BPAX News:

 

August 13 - BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in Phase III Program

 

BioSante Pharmaceuticals, Inc. (Nasdaq: BPAX), announced positive safety data in its ongoing LibiGel Phase III clinical development program.

 

BioSante reported that with over 1,250 women enrolled and almost 825 women-years of exposure in its LibiGel Phase III clinical development program, there have been no deaths and only five cardiovascular events. This analysis of blinded data indicates a very low cardiovascular event rate has occurred thus far. Therefore, in view of the excellent LibiGel safety profile, BioSante’s LibiGel Phase III development program will continue as planned. BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.

 

“The cardiovascular safety data indicate that LibiGel, to date, has been shown to be safe,” said Stephen M. Simes, BioSante’s president and CEO. “We are happy to see that LibiGel continues to show its safety in healthy women, and also in those women with at least two cardiac risk factors enrolled in our cardiovascular and breast cancer safety study. We will continue to analyze blinded cardiac event data on a regular basis. LibiGel remains the only pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need also referred to as female sexual dysfunction (FSD).”

 

The Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that will enroll between 2,400 and 3,100 women, exposed to LibiGel or placebo for 12 months. An NDA can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.

 

The LibiGel safety study is tracking a predefined list of cardiovascular events, in agreement with the FDA, including cardiovascular death, myocardial infarction and stroke, in women 50 years of age or older and suffering from at least two cardiovascular risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study.

 

In addition to the Phase III cardiovascular and breast cancer safety study, BioSante is conducting two LibiGel Phase III efficacy trials. The Phase III efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement).

 

As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

 

HARD TO TREAT DISEASES INCORPORATED (OTC: HTDS)

"Up 38.35% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/HTDS.php 

 

In June 2003, International Foam Solutions, Inc. changed its name to Hard to Treat Diseases, Inc. in connection with the completion of a share exchange agreement with Hard to Treat Diseases and T-19, Inc. Hard to Treat Diseases, Inc. holds the international marketing rights, except South Korea, to Tubercin, a patented immunostimulant developed for combating cancer and rheumatoid arthritis under medical patent. Tubercin promotes good health by enhancing the immune system. The nasal spray would be distributed through major holistic retailers and providers worldwide.

 

HTDS News:

 

August 12 - Hard To Treat Diseases Completes IP Ownership Filings With U.S. Patent and Trademark Office

 

Hard to Treat Diseases (OTC: HTDS) announced that the Company has completed the necessary filings required to correct the ownership of its intellectual property (IP) rights.

 

Having performed an extensive audit and investigation on five (5) issued patents, HTDS finds that the Company should have been assigned full ownership of the patents. Filings were made today with the U.S. Patent and Trademark Office that formalize, and secure HTTD's ownership and rights to the patents.

 

In summary, The IP rights are being utilized by a fully reporting OTCBB publicly traded company. As a result of HTDS IP rights, this company has raised substantial monies in equity financing, constructed an operating plant that generates revenue, is in the process of purchasing parcels of property in various States in order to construct additional plants. It also has had numerous industrial bonds approved for several million dollars each.

 

The issuer for the time being has elected not to name the OTCBB publicly traded company that is utilizing its rights, however HTDS has placed the OTCBB company on formal notice. Notwithstanding, HTDS management is looking towards a mutually amicable resolution of this matter. HTDS is of the opinion that this OTCBB company got off to a great start, primarily because of these patents, which rightfully belong to HTDS. HTDS takes the position that there is no good or valid dispute that these IP rights belong to anyone else but HTDS.

 

The issuer expects a "knee jerk" reaction by the OTCBB Company, including the standard form letter type denials issued by their barristers, a denouncement and a host of other panic stricken immediate type reactions. HTDS management intentions are neither to harm the OTCBB operations nor to destabilize OTCBB shareholders value. Instead, it will seek a harmonious "win-win" solution. Once the rights are finalized, HTDS is positioning itself to aggressively move the recycling industry to a higher level, with a separate recycling operating division inside HTDS; which should not disrupt HTDS' primary Bio Chem and Vaccine business. In the event the OTCBB utilizing HTDS rights is willing to cooperate, HTDS may very well have found a new partner. HTDS management is also mindful that refusal of this infringement may leave the HTDS management with no other alternative but to attorn these IP rights and to appoint an interim HTDS management to assume the recycling operations.

 

The management of HTDS is not ruling out any options at this point. Either way, once HTDS assumes control, the management anticipates gross revenue exceeding $250 million within two years.

 

Resolutions and a decision are expected shortly.

 

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