Our Stocks to Watch tomorrow include Global IT Holdings Inc. (OTC: GITH), VIA Pharmaceuticals Inc. (Nasdaq: VIAP), Universal Detection Technology Inc. (OTCBB: UNDT), Dynavax Technologies Corp. (Nasdaq: DVAX), Generex Biotechnology Corp. (Nasdaq: GNBT) and Discovery Laboratories Inc. (Nasdaq: DSCO).
Visit http://www.otcpicks.com/microcap.htm today to join this growing community.
GLOBAL IT HOLDINGS INCORPORATED (OTC: GITH)
"Up 200.00% on Thursday"
Detailed Quote: http://www.otcpicks.com/quotes/GITH.php
Global IT Holdings, Inc. provides a range of specialized staffing and project implementation services and products in the
GITH News:
September 10 - Global IT Holdings Inc. Enters Into Negotiations With Second Acquisition
Global IT Holdings Inc. (OTC: GITH) Chief Executive Officer Eric Stratton Racheff issues the following statement to shareholders:
"I am pleased to announce that we have entered into negotiations with a staffing company for our 2nd acquisition. This company leads the way in professionalism and speed when finding specialized employees for its clients. We are moving forward with the proposal and negotiation process.
"This is our 2nd company that we are in the process of acquiring. We will continue to be adding value to the company by acquiring companies in many fields that we specialize in. Over the next few months shareholders will see multiple companies added to our team.
"Also for shareholders, our website will be updated regularly with press releases, filings, information about us and our new subsidiaries."
VIA PHARMACEUTICALS INCORPORATED (NASDAQ: VIAP)
"Up 22.50% on Thursday"
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.
UNIVERSAL DETECTION TECHNOLOGY (OTCBB: UNDT)
"Up 15.22% on Thursday"
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 45.71% on Thursday"
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.
GENEREX BIOTECHNOLOGY CORPORATION (NASDAQ: GNBT)
"Up 22.06% on Thursday"
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™ 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."
DISCOVERY LABS INCORPORATED (NASDAQ: DSCO)
"Up 47.92% on Thursday"
Detailed Quote: http://www.otcpicks.com/quotes/DSCO.php
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 Surfactant Technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary Capillary Aerosolization Technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs is focused initially on developing its KL4 surfactant pipeline to build a pediatric franchise that will potentially address several respiratory conditions affecting neonates and young children, beginning with Respiratory Distress Syndrome (RDS).
DSCO News:
September 10 - Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for SURFAXIN Approval
Discovery Laboratories, Inc. (Nasdaq: DSCO) has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for September 29, 2009. This meeting will serve as a follow-up to the June 2 meeting with the FDA and the FDA's April 17 Complete Response letter. The objective of this meeting is to define the options available to Discovery Labs to resolve the remaining primary issue that Discovery Labs must address to gain
At the upcoming September 29 meeting, Discovery Labs plans to discuss with the FDA a limited Surfaxin clinical trial design and whether conducting such trial, while simultaneously employing the fetal rabbit Biological Activity Test (BAT, a quality control and stability release test), could potentially address the key remaining requirement for Surfaxin approval. This approach was suggested by the FDA at the June 2 meeting as a way for Discovery Labs to increase the likelihood of gaining Surfaxin approval. In addition, Discovery Labs plans to review its ongoing quality improvement efforts, intended to further refine the BAT in accordance with Discovery Labs' continuing quality improvement initiatives, with the FDA.
Background
The April 17 Complete Response letter from the FDA and the June 2 meeting focused primarily on certain aspects of the BAT, specifically whether preclinical data generated using both the BAT and a well-established preterm lamb model of RDS adequately supports the comparability of Surfaxin clinical drug product to the to-be-manufactured Surfaxin, and whether the BAT can adequately distinguish change in Surfaxin biological activity over time.
During the conduct of Phase 3 clinical trials for Surfaxin, Discovery Labs employed an array of quality control tests, but did not employ the BAT to evaluate biological activity of the Surfaxin clinical drug product. After completing the Phase 3 clinical trials, in accordance with discussions with the FDA, Discovery Labs validated and implemented the BAT as a recurring quality control test to confirm biological activity for Surfaxin release and stability testing. Based on agreements reached in meetings with the FDA in 2006 and 2008, Discovery Labs conducted a series of preclinical experiments to establish comparability between Surfaxin drug product used in Phase 3 clinical trials and the Surfaxin drug product intended to be manufactured for commercial use. Accordingly, Discovery Labs initiated a series of side-by-side studies employing both the preterm lamb model of RDS and the BAT and believes that the correlated results demonstrate comparability and support approval of Surfaxin.
At the June 2 meeting with the FDA, Discovery Labs presented data from the preterm lamb model and BAT studies, together with a comprehensive statistical evaluation of such data, intended to establish the comparability of clinical drug product to Surfaxin drug product to be manufactured for commercial use. The comprehensive statistical evaluation was a comparative regression analysis using an accepted FDA statistical method. Discovery Labs believes that the data and related statistical evaluation are highly supportive of the comparability of clinical drug product to commercial Surfaxin.
However, the FDA stated at the June 2 meeting, that data generated from the preterm lamb model and BAT studies must demonstrate, in a point-to-point analysis, the same relative changes in respiratory compliance between both models over time. Based on this standard, Discovery Labs believes that establishment of comparability in this manner would be an extremely high hurdle and that, from the FDA's perspective, the data analysis provided by Discovery Labs did not meet that standard.
In addition, the FDA suggested that the comparability studies in the preterm lamb model and the BAT would not be necessary if the BAT had been implemented to assess Surfaxin drug product used in the Phase 3 clinical trials. The FDA also suggested that, to increase the likelihood of gaining Surfaxin approval and as an alternative to demonstrating comparability using the preterm lamb model and BAT, Discovery Labs could consider conducting a limited clinical trial, while simultaneously employing the BAT, as a path forward to Surfaxin approval.
OTCPicks.com is located at
DO NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND ON THIS REPORT. We are not registered as a securities broker-dealer or an investment adviser either with the U.S. Securities and Exchange Commission (the "SEC") or with any state securities regulatory authority. We are neither licensed nor qualified to provide investment advice. OTCPicks.com makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person or that an investment such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk. You are receiving this email because you have registered on OTCPicks.com or one of our affiliate companies.
The information contained in our report should be viewed as commercial advertisement and is not intended to be investment advice. The report is not provided to any particular individual with a view toward their individual circumstances. The information contained in our report is not an offer to buy or sell securities. We distribute opinions, comments and information free of charge exclusively to individuals who wish to receive them.
Our newsletter and website have been prepared for informational purposes only and are not intended to be used as a complete source of information on any particular company. An individual should never invest in the securities of any company profiled based solely on information contained in our reports. Individuals should assume that all information contained in the report about profiled companies is not trustworthy unless verified by their own independent research.
Any individual who chooses to invest in any securities should do so with caution. Investing in securities is speculative and carries a high degree of risk; you may lose some or all of the money that is invested. Always research your own investments and consult with a registered investment advisor or licensed stockbroker before investing.
Information contained in our report will contain "forward looking statements" as defined under Section 27A of the Securities Act of 1933 and Section 21B of the Securities Exchange Act of 1934. Subscribers are cautioned not to place undue reliance upon these forward-looking statements. These forward-looking statements are subject to a number of known and unknown risks and uncertainties outside of our control that could cause actual operations or results to differ materially from those anticipated. Factors that could affect performance include, but are not limited to, those factors that are discussed in each profiled company's most recent reports or registration statements filed with the SEC. You should consider these factors in evaluating the forward-looking statements included in the report and not place undue reliance upon such statements. We are committed to providing factual information on the companies that are profiled. However, we do not provide any assurance as to the accuracy or completeness of the information provided, including information regarding a profiled company's plans or ability to effect any planned or proposed actions. We have no first-hand knowledge of any profiled company's operations and therefore cannot comment on their capabilities, intent, resources, nor experience and we make no attempt to do so. Statistical information, dollar amounts, and market size data was provided by the subject company and related public information sources which we believe to be reliable but we cannot guarantee the accuracy of the information. To the fullest extent of the law, we will not be liable to any person or entity for the quality, accuracy, completeness, reliability, or timeliness of the information provided in the report, or for any direct, indirect, consequential, incidental, special or punitive damages that may arise out of the use of information we provide to any person or entity (including, but not limited to, lost profits, loss of opportunities, trading losses, and damages that may result from any inaccuracy or incompleteness of this information). We encourage you to invest carefully and read investment information available at the websites of the SEC at http://www.sec.gov and FINRA at http://www.finra.org.
Disclosure: OTCPicks.com has not been compensated by any of the companies covered in this release.
