Our Stocks to Watch today include Access Pharmaceuticals Inc. (OTCBB: ACCP), Organa Gardens International Inc. (OTCBB: OGNG), Kender Energy Inc. (OTC: KNDR), China Youth Media Inc. (OTCBB: CHYU), eWorld Companies, Inc. (OTC: EWRC), SGD Holdings Ltd. (OTC: SGDH), Jaguar Mining Enterprises Inc. (OTC: JAGR), Universal Detection Technology Inc. (OTCBB: UNDT), Dynavax Technologies Corp. (Nasdaq: DVAX), Alloy Steel International Inc. (OTCBB: AYSI), Encorium Group Inc. (Nasdaq: ENCO), VIA Pharmaceuticals Inc. (Nasdaq: VIAP) and Generex Biotechnology Corp. (Nasdaq: GNBT).
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ACCESS PHARMACEUTICALS INCORPORATED (OTCBB: ACCP)
"Up 8.76% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/ACCP.php
Company Profile: http://www.otcpicks.com/access-pharmaceuticals/access-pharmaceuticals.htm
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac™, currently in Phase 2 clinical testing of patients with ovarian cancer, and MuGard™ for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin™-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix®, a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.
ACCP News:
September 10 - Access Pharmaceuticals Provides Update on ProLindac™ Clinical Development Plan
Finalizing Plans for Combination Studies in Liver, Pancreatic and Ovarian Cancers Access Pharmaceuticals Inc. (OTCBB: ACCP), provided an update today on the Company's clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. Access' clinical development team recently met with its partners Aosaikang Medicinal Group (ASK) in
Access previously announced positive safety and efficacy results from its Phase 2 monotherapy clinical study of ProLindac in late-stage, heavily pretreated ovarian cancer patients. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.
The recent Phase 2 recurrent ovarian study explored three different dose levels and two dosing regimens of ProLindac as a monotherapy treatment for advanced ovarian cancer, to provide data on the monotherapy anticancer activity and safety of ProLindac. Of patients eligible for evaluation according to standard RECIST criteria, clinically-meaningful disease stabilization was achieved in 42% of all patients, and 66% of all patients in the higher dose groups. Sustained and significant reductions in Ca-125, the established specific serum marker for ovarian cancer, were also observed in several patients.
"Access is extremely pleased with the clinical progress to date, and look forward to initiation of clinical trials looking at ProLindac in combination with commonly used chemotherapies," stated Jeffrey Davis, President & CEO. "Our partners in the Far East hosted Access together with key opinion leaders in oncology indications to discuss various potential protocol options, and hope to start enrolling patients in up to three combination trials by the end of the year, depending upon regulatory approvals of the trial protocols and certain other matters."
ABOUT PROLINDAC™
ProLindac is a novel DACH platinum prodrug which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials. Access believes that ProLindac's unique molecular design potentially could eliminate some of the toxic side effects seen in the currently marketed DACH platinum, Eloxatin, which has sales in excess of $2 billion. Access has previously announced that it has licensed ProLindac to Aosaikang Medicinal Group ("ASK") for the Greater China Region and to JCOM, Ltd for
ORGANA GARDENS INTERNATIONAL INCORPORATED (OTCBB: OGNG)
Detailed Quote: http://www.otcpicks.com/quotes/OGNG.php
Company Profile: http://www.otcpicks.com/Newsletter/OGNA_NA_090909.html
Organa Gardens International Inc. has a vertical hydroponics farming system built to make the most efficient use of light, energy, water, land, temperature and production cycle while growing the highest quality and healthiest plants in an optimum, consistent environment unaffected by weather. The Organa Garden Systems (OGS) provide a means for food production and consumption change to global environmental and ecological sustainability through vertical hydroponics rotary farming.
OGNG News:
September 10 - Global Market Demand for Premium Organic Foods Continues
Organa Gardens International Inc. (OTCBB: OGNG) has a vertical hydroponic farming system known as OGS-E. The OGS-E will virtually eliminate current problems like transportation costs, pollution and product spoilage while enabling the grower/farmer to realize the same crop yield using between one-fifth to one-tenth the land currently needed depending on the crop being grown. The fully automated system recycles and reuses 95% of the water used while requiring a negligible amount of energy to run. The system uses a specially developed nutrient fertilizer which enables it to produce a higher quality of fruits and vegetables.
In a March 2009 report by Global Business Insights, "The organic food and drinks market grew rapidly over the first part of the decade with sales in the
More and more people are turning to organic food as a more reliable and safer way to feed themselves and their family. Artificial ingredients used to make a product low fat or low in calories are starting to be questioned. Strange-sounding ingredients are a concern for consumers. Most consumers now recognize the fact that non-organic foods can contain pesticides, chemical fertilizers and herbicides. Food scares such as BSE and more recently Avian Flu have not only had a detrimental effect on various industries, but also awakened consumer interest in where their food actually comes from. Consumers are starting to question the trust and loyalty they have placed in the food and drinks industry to date.
Organa is in the process of bringing its OGS-E into commercial production and feels its gardening technology is the answer for the concerned consumer. Company president Christopher Scheive states, "Organa's reinventing the food wheel will enable consumers to grow organic goods without the risks of pesticides, crop pests, and soil borne diseases while reaping the rewards of higher yields and seasonal extension of crop growth."
KENDER ENERGY INCORPORATED (OTC: KNDR)
Detailed Quote: http://www.otcpicks.com/quotes/KNDR.php
Company Profile: http://www.otcpicks.com/kender-energy.htm
Kender Energy Inc. is a development phase company active in the field of solar energy. Its present prototypes of solar panels are being developed into a full-scale solar energy production system. The particularity of the Kender solar panel system and technology is to allow, via a closed circuit of gas (usually helium), to create a heat exchange with the sunlight and the air from the environment. The exchange generates the spinning of the helium gas in the closed circuit, propelling a turbine, which produces electricity in a 100% clean and renewable process. The system's main advantages are that it is efficient, cheap in production, and modular. The company is based near
KNDR News:
September 10 - Kender Energy to Distribute Its Solar Technology in
Kender Energy Inc. (OTC: KNDR) announced that it has signed a distribution agreement for the country of
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September 9 - Kender Energy Publishes Its Corporate Video Profile
Kender Energy Inc. (OTC: KNDR) announced that it has published its corporate video profile on its website at www.kendersolar.com/index.php/Kender-Corporate-Video.html.
Detailed Quote: http://www.otcpicks.com/quotes/CHYU.php
Company Profile: http://www.otcpicks.com/china-youth-media/china-youth-media.htm
China Youth Media, Inc. is a China-focused youth marketing and media company whose business is to deliver advertising and content to one of the most sought after and fastest growing demographics in the world. Through its wholly owned subsidiary Youth Media (Hong Kong) Limited, CHYU has secured contracts with a term of 20 plus 10 years that provide exclusive rights from the Chinese government controlled corporation, China Youth Interactive, which uniquely position CHYU to market to China’s massive student population with preferred access online, on campus and on mobile. CHYU currently targets
CHYU News:
September 9 -
China Youth Media, Inc. (OTCBB: CHYU), a China focused youth marketing and media company, announced that its Koobee Network has launched an advertising campaign for the athletic footwear company Converse, a subsidiary of the world’s leading athletic shoes and apparel company, Nike.
Koobee, China Youth Media’s Intranet Television Network and media portal, delivers TV-quality content and advertising directly to China’s 30 million plus college students on a dedicated network targeted to campuses nationwide. The Converse ad campaign is running on Koobee’s recently launched MOGO Music Channel. Produced for and targeted specifically to
“We are very pleased to launch the Converse campaign on Koobee and expect it to become one of many to generate ad revenue for the company,” commented Jay Rifkin, China Youth Media’s CEO. “As more campaigns like this are sold, we believe that Koobee’s highly targeted youth platform will become premium ad inventory for major global brands.”
EWORLD COMPANIES INCORPORATED (OTC: EWRC)
Detailed Quote: http://www.otcpicks.com/quotes/EWRC.php
Company Profile: http://www.otcpicks.com/eworld-companies/eworld-companies.htm
eWorld Companies, Inc. is an online marketing & advertising technologies company that develops and markets cutting edge technologies using rich media, flash, animation and 3D graphics to help individuals and businesses market and advertise online. eWorld's revenue model consists of seven components: (1) Affiliation Fees, (2) Affiliate Monthly Subscriptions, (3) Affiliate Benefit Subscriptions, (4) Product Sales, (5) Advertising Revenues, (6) Web Development Accounts, and (7) International Licensing Fees.
EWRC News:
September 9 - eWorld Companies Receives Major Offer for Purchase of All Outstanding Shares
eWorld Companies, Inc. (OTC: EWRC) has received an offer for purchase of all of the company's outstanding shares for 1.9 cents a share. eWorld CEO Henning Morales has forwarded the offer to the company's attorneys for review and due diligence, and the shareholders will be kept informed as further information becomes available.
SGD HOLDINGS LIMITED (OTC: SGDH)
"Up 6.49% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/SGDH.php
Company Profile: http://www.otcpicks.com/sgd-holdings/sgd-holdings.htm
SGD Holdings, Ltd. is a holding company which owns and operates through its wholly-owned subsidiary, Ecopaper, Inc. (www.ecopaper.com). Its goal is to acquire new technologies which can positively impact the environment either through internal development or by acquisition.
SGDH News:
September 9 - SGD Holdings, Ltd. Subsidiary, Ecopaper, Inc. Sells 50% of a Container of Bulk Banana Paper
SGD Holdings, Ltd. (OTC: SGDH) announced that its wholly-owned subsidiary, Ecopaper, Inc., pre-sold one half container shipment of bulk banana paper to a wholesale client for $28,000. The balance of the container will go into its retail internet inventory to be sold through www.ecopaper.com.
"Increasing consumer demand for our environmentally sustainable tree-free paper products has significantly increased our bulk paper and retail internet sales. Our Central American facility specializes in providing products from the agricultural waste of banana plantations. Increased demand will lower our shipping costs and has improved our overall profit margins," stated Harry Johansing, CEO of SGD Holdings, Ltd.
ABOUT ECOPAPER, INC.
Ecopaper, Inc. is the first company in the history of the paper industry to create and market treeless paper of a superior quality. Every page of Ecopaper is smooth, acid-free, durable, chemical-free, and made in
JAGUAR MINING ENTERPRISES INCORPORATED (OTC: JAGR)
Detailed Quote: www.otcpicks.com/quotes/JAGR.php
Company Profile: http://www.otcpicks.com/jaguar-mining/jaguar-mining.htm
Jaguar Mining Enterprises, Inc. is an independent mining company engaged in the acquisition, development, and exploitation of iron ore primarily mined in
JAGR News:
September 9 - Jaguar Mining Enterprises Issues Special Letter to Shareholders
Jaguar Mining Enterprises, Inc. (OTC: JAGR), an independent mining company engaged in the acquisition, development, and exploitation of iron ore primarily mined in Mexico, announced that it has issued a Special Letter to Shareholders to update existing JAGR investors on the current status of Jaguar Mining, and more importantly, its future growth outlook. Excerpts from the letter follow:
"Currently, our primary emphasis is to develop an iron ore reserve containing 20 million metric tons (mt) at our Cascaronal Project in
"In spite of recent market volatility, we expect that rising worldwide demand will likely produce a tight market into next year. Iron ore prices are normally set in annual talks between major suppliers and customers. As they have been unable to agree upon a benchmark price, iron ore is being sold on the open market. Prices spiked in early August, but we have seen a decline since then. The company's policy of strict fiscal discipline and cost control will help us weather these up and down prices we're now seeing, and allow us to be profitable as we move forward."
The full shareholder letter can be viewed on Jaguar Mining's website at www.jaguarminingenterprises.com.
UNIVERSAL DETECTION TECHNOLOGY (OTCBB: UNDT)
"Up 26.09% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/UNDT.php
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 bacterial spore detector that detects certain biohazard substances. The company is also a reseller of handheld assays used for detection of five bioterrorism agents, radiation detection systems, and antimicrobial products.
UNDT News:
September 10 - Universal Detection Technology Awarded
Universal Detection Technology (OTCBB: UNDT), a developer of early-warning monitoring technologies and counter-terrorism training programs to protect people from bioterrorism and other infectious health threats, announced today that it had received a contract from the Aerospace Data Facility-East, a part of the Department of Defense's National Reconnaissance Office. The contract includes equipment for the detection of harmful bio-agents, including anthrax, ricin and botulinum toxins.
"This contract will provide vital bioterrorism detection equipment to the DoD for a very sensitive sector of our national security and intelligence," said Jacques Tizabi, CEO of Universal Detection Technology. "As the public and private sectors realize the risks of bioterrorism activity, we will provide them with the necessary tools to meet those risks," said Tizabi.
Universal Detection Technology's bio-warfare detection equipment is used extensively by first responders and private industry throughout the country. The equipment has been evaluated by the U.S. DoD as well as the
A DoD agency, the National Reconnaissance Office (NRO) is part of the 16-member Intelligent Community, and is charged with building and operating the nation's reconnaissance satellites. The NRO provides intelligence-gathering tools to the Central Intelligence Agency (CIA) and the Department of Defense (DoD).
DYNAVAX TECHNOLOGIES INCORPORATED (NASDAQ: DVAX)
"Up 59.54% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/DVAX.php
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health.
DVAX News:
September 10 - Dynavax Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine
Dynavax Technologies Corporation (Nasdaq: DVAX) announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease. HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.
As a result of the FDA’s decision, Dynavax expects to initiate a Phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.
“The success of our scientific approach to resolving the clinical hold on HEPLISAV allows us to resume development of our enhanced hepatitis B vaccine,” commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. “After achieving strong efficacy data in our prior Phase 3 pivotal trial, we are fully prepared to initiate the final registration trials for HEPLISAV.”
Dynavax’s global strategy as previously discussed with the FDA and the European Medicines Evaluation Agency (EMEA) is to develop HEPLISAV for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.
ABOUT HEPLISAV
HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines. Over 2,500 individuals have been vaccinated with HEPLISAV to date.
Phase 3 data from Dynavax’s PHAST clinical trial demonstrate subjects over 40 years of age receiving 2 doses of HEPLISAV over a 1 month period achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over a 6 month period. For individuals with chronic kidney disease, clinical data from a small Phase 1 and partially completed Phase 2 trial will be reported at an upcoming medical conference.
Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
ABOUT HEPATITIS B VACCINES
The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations.
Chronic Kidney Disease Market – A high-value segment, the chronic kidney disease market is large, growing rapidly, and is widely recommended for vaccination. There are approximately 750,000 end-stage renal disease (ESRD) patients in the
Other Markets
Other populations such as individuals infected with HIV or diagnosed with chronic liver disease are also less responsive to current hepatitis B vaccines and represent a large, poorly served market opportunity.
ALLOY STEEL INTERNATIONAL INCORPORATED (OTCBB: AYSI)
"Up 15.58% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/AYSI.php
Alloy Steel International, Inc., together with its subsidiary, Alloy Steel Australia (Int.) Pty Ltd., engages in the manufacture and distribution of Arcoplate, a wear-resistant alloy overlay wear plate. It offers fused-alloy steel plates for installation and use in structures and machinery that suffer wear and hang-up problems. The company is also developing the 3-D Pipefitting Cladder process. Alloy Steel International's customer base primarily consists of companies involved in the mining and dredging industries in
AYSI News:
September 8 - Alloy Steel International Signs Supply Agreement With BHP Billiton
Mr. Gene Kostecki, Chairman and CEO of Alloy Steel International (OTCBB: AYSI), announced that Alloy Steel Australia (Int) Pty Ltd a wholly owned subsidiary of Alloy Steel International Inc. has signed a long term strategic supply agreement with BHP Billiton to supply Arcoplate Wear Resistant Super Alloy Wearplate for iron ore mining operations in Western Australia.
The initial product taken will be for the multi-million dollar expansion of their operations in the Pilbara area of
Since the announcement in August 2009 of Alloy Steel's successful commissioning, the increased level of interest in the new production mill shown in Arcoplate has been outstanding, according to Mr. Kostecki. Most of the major iron ore miners in
Since commissioning the new Arcoplate mill, it has been working at full capacity satisfying the demand for the new 3/4 inch or 20mm material whilst the other Arcoplate mill has been fully utilized with the ongoing demand for the thinner overlay materials.
As a result of the increased level of interest in Alloy Steel's Arcoplate product by local and international mining companies, the Directors of Alloy Steel are planning for a further two production mills with substantially increased capacity to come on line in early 2010.
ENCORIUM GROUP INCORPORATED (NASDAQ: ENCO)
"Up 5.63% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/ENCO.php
Encorium Group, Inc. is a global clinical research organization specializing in the design and management of complex clinical trials and Patient Registries for the pharmaceutical, biotechnology and medical device industries. The Company's mission is to provide its clients with high quality, full-service support for their biopharmaceutical and medical device development programs. Encorium offers therapeutic expertise, experienced team management and advanced technologies. The Company has drug and biologics development as well as clinical trial experience across a wide variety of therapeutic areas such as infectious diseases, cardiovascular, vaccines, oncology, diabetes endocrinology/metabolism, gene therapy, immunology, neurology, gastroenterology, dermatology, hepatology, women's health and respiratory medicine. Encorium believes that its expertise in the design of complex clinical trials, its therapeutic experience and commitment to excellence, and its application of innovative technologies, offer its clients a means to more quickly and cost effectively move products through the clinical development process.
ENCO News:
September 8 - Encorium Group, Inc. Announces New Business Awards of $8.7 Million, Including Swine Flu (Influenza A H1N1 virus) Vaccine Trial Win
Company Successful with its Strategic Focus on Vaccines and Oncology Trials
Encorium Group, Inc. (Nasdaq: ENCO), a full-service multinational contract research organization (CRO) that provides design, development, and management capabilities for clinical trials and patient registries to many of the world's leading pharmaceutical companies, today announced the signing of approximately $8.7 million of new business contracts, including selection by a major pharmaceutical company for participation in a swine flu vaccine program.
Dr. Kai Lindevall, executive chairman stated, "We are delighted to be able to announce these new business awards, despite a very challenging market environment. Our experience and capabilities in the vaccine field have been of paramount importance in our success. We are very proud of being the selected partner for one of the frontline clinical development programs for the swine flu vaccine. In addition, we were also recently entrusted with a avian flue vaccine, as well as other vaccine development programs having, in the aggregate, approximately 12,000 patient subjects. We believe our participation in these studies exemplifies the level of trust and respect that large vaccine companies have in our vaccine expertise and clinical operations.
"We believe Encorium has developed into one of the strongest medium sized clinical research organizations with expertise in the field of clinical vaccine development. Our recent success in the vaccine field has been substantial, with revenues from vaccine trials increasing by 150% in 2009 versus 2008. As an acknowledgement of our achievements, in April 2009, Encorium was nominated as a finalist for the Second Annual Vaccine Industry Excellence Award.
"The establishment of our Core Vaccine Team has made it possible to enter strategic partnerships with a number of clients. Moving forward, our goal is to grow into the world's leading vaccine franchise and to create a vertical niche expertise in the field of vaccine research, covering pre-clinical support, regulatory consultancy and strategic trial planning. As an integral part of this strategy, the Company has began and plans to continue creating global investigator and clinic networks to strengthen the Company's ability to conduct large scale global phase III vaccine trials. Through these networks it will be possible for us to achieve fast and efficient subject/patient recruitment for vaccine trials globally, which will also ensure a strong local ownership and a strong ethical foundation.
"The Company has also been successful in winning trials in the field of oncology during 2009. Thus far in 2009, Oncology trials constitute the second largest revenue generating therapeutic field after vaccines. We believe our vaccine experience will continue to assist us in gaining new contract wins in the oncology sector, as we will continue to focus, not just on prophylactic vaccines, but also on therapeutic vaccines, which constitute a substantial number of oncology trials and are the fastest growing area within vaccine development. Based on our expertise and success in the field of vaccines and oncology, we believe we are well positioned to further strengthen our market position in these niche areas."
The new business awards announced today mitigate any negative impact to our backlog as reported at June 30, 2009 from foreign currency translations, contract amendments and terminations and revenue recognized. The Company had reported consolidated backlog at June 30, 2009 from continuing operations of $19.6 million which compared to a backlog of $23.5 million at June 30, 2008.
VIA PHARMACEUTICALS INCORPORATED (NASDAQ: VIAP)
"Up 12.85% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/VIAP.php
VIA Pharmaceuticals, Inc. is a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease. VIA's lead candidate, VIA-2291, targets a significant unmet medical need: reducing inflammation in the blood vessel wall, which is an underlying cause of atherosclerosis and its complications, including heart attack and stroke. In addition, VIA's pipeline of drug candidates includes other compounds to address other underlying causes of cardiovascular disease: high cholesterol, diabetes and inflammation.
VIAP News:
July 17 - VIA Pharmaceuticals Receives Anticipated Notice From NASDAQ
VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, announced that it received a Staff Determination letter, dated July 15, 2009, from the NASDAQ Stock Market stating that the Company has not regained compliance with the minimum $2,500,000 stockholders' equity requirement for continued listing, as set forth in Listing Rule 5550(b), and that the Company's securities are, therefore, subject to delisting from The NASDAQ Capital Market.
The Company intends to file an appeal of the NASDAQ Staff Determination by July 22, 2009 and to request a hearing before a NASDAQ Listing Qualifications Panel (the "Panel"), which request will stay the delisting of the Company's securities pending the Panel's decision. There can be no assurance that the Panel will grant the Company's request for continued listing on The NASDAQ Capital Market.
GENEREX BIOTECHNOLOGY CORPORATION (NASDAQ: GNBT)
"Up 30.49% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/GNBT.php
Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in
GNBT News:
September 10 - Generex Announces USFDA Approval of Use of Company's Flagship Buccal Insulin Product, Generex Oral-lyn™, Under the USFDA'S Treatment Investigational New Drug (IND) Program
Generex Biotechnology Corporation (Nasdaq: GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the treatment use of Generex Oral-lyn™ under the FDA's Treatment Investigational New Drug (IND) program.
The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing.
Under a structured Treatment IND protocol, Generex Oral-lyn™ will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company's ongoing global Phase III pivotal clinical trial.
This Treatment IND will be open to eligible patients that comply with the inclusion/exclusion criteria of the protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this
In order to learn more about the availability of Generex Oral-lyn™ under the IND Treatment program, as per FDA requirements, the Company will be providing information within the www.ClinicalTrials.gov website. Details will include study design and participating sites and/or physicians. Please note that the drug will be available only through physicians who are registered in the Treatment IND program.
"We are excited about having the opportunity to meet the needs of American patients living with diabetes who have no satisfactory alternative treatment and have contacted the Company, based on their special needs, about possible access to Generex Oral-lyn™," stated Anna Gluskin, Generex's President and Chief Executive Officer. "This opportunity to provide those in critical need of Generex Oral-lyn™ will continue while the pivotal Phase III study concludes and the Company prepares for its New Drug Submission with the USFDA and other major health authorities in key markets."
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Disclosure: OTCPicks.com has been compensated three thousand five hundred dollars from a third party (Longview Communications Corp.) for ACCP advertising and promotional services. OTCPicks.com has been compensated five thousand dollars by a third party for OGNG advertising and promotional services. OTCPicks.com has been compensated two thousand five hundred dollars by a third party (BlueWave Advisors) for KNDR advertising and promotional services. OTCPicks.com has been compensated nine thousand five hundred dollars by the company for CHYU advertising and promotional services. OTCPicks.com is being compensated eight thousand dollars by a third party (Mickey Reno) for EWRC advertising and promotional services. OTCPicks.com is being compensated eight thousand dollars by a third party (Stock Awareness Group) for SGDH advertising and promotional services. OTCPicks.com has been compensated two hundred thousand free trading shares by a third party (Microcap Management) for JAGR advertising and promotional services. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. OTCPicks.com is a website partially owned by BlueWave Advisors, LLC, a financial public relations firm. BlueWave Advisors, LLC, its principal and/or its affiliates will hold positions in the company profiled and may buy or sell securities at any time without notice.
