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"Stocks that Standout" picks for today are: CYTR, GNBT, MMTC, TEVA
(M2 PressWIRE Via Acquire Media NewsEdge) "Stocks that Standout" picks for today are: CytRx Corporation (NASDAQ: CYTR), Generex Biotechnology Corporation (Nasdaq: GNBT), Micro Imaging Technology, Inc. (OTCBB: MMTC), Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA)!
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Jun 29, 2009 -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today provided a favorable progress update for its ongoing Phase 2 STAR-1 registration clinical trial to evaluate the efficacy and safety of orally administered tamibarotene as a third-line treatment for acute promyelocytic leukemia (APL).
The primary endpoint of the open-label, non-randomized STAR-1 trial is to determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients following treatment failure with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO). A durable complete response is achieved when no leukemia cells can be found in the bone marrow (morphologic leukemia-free state or MLFS), the patient's neutrophil and platelet counts (blood cells) are increased to a certain level, and there is no sign of disease outside of the blood and bone marrow. All of these criteria must be satisfied for at least 28 days to be considered a durable complete response.
Of the 11 patients enrolled in the STAR-1 trial to date, two patients have achieved durable complete response and one has achieved MLFS, but withdrew from the trial to receive a bone marrow transplant before the durable complete response could be confirmed. One patient achieved a complete response, but did not maintain MLFS for the required 28 days to be considered a durable complete response. Another patient achieved a durable MLFS, but did not have the necessary increases in blood cells to be considered a durable complete response.
"We are highly encouraged by the trial patients' response to tamibarotene, with five of the 11 APL patients, or 45%, achieving MLFS after failing on two other drug therapies," said Steven A. Kriegsman, CytRx President and CEO. "We are aggressively working to achieve our goal of completing this trial by the end of the current year, which may include acceleration of the trial through a negotiation with the FDA regarding the total number of patients ultimately enrolled, and filing an NDA submission with the FDA in 2011."
CytRx holds the North American and European rights to tamibarotene, a rationally designed, synthetic retinoid compound designed to potentially overcome resistance to and avoid the toxic side effects of ATRA - used in the current first-line APL treatment. The STAR-1 pivotal clinical trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA). The FDA also has granted Orphan Drug Designation for the treatment of APL and Fast Track Designation for the use of tamibarotene in patients with relapsed or refractory APL. In addition, CytRx expects tamibarotene to be granted European orphan medicinal product designation for treatment of APL in the coming weeks.
Tamibarotene is approved in Japan for use in relapsed or refractory APL. The approval was based on data from two studies in Japanese patients. In the pivotal study, the effectiveness of tamibarotene was evaluated in 39 patients with APL, including patients who had never received treatment for APL and patients who had been previously treated with ATRA. The overall complete response rate in these patients was 61.5%. In patients who had a recurrence of APL following ATRA therapy, the response rate was 81%.
APL is diagnosed in approximately 1,500 new patients in the United States annually. There are currently no approved third-line treatment options for refractory APL patients, an annual market that CytRx estimates at approximately $20 million in the United States and $25 million in Europe. CytRx scientists also continue evaluating clinical strategies for developing tamibarotene as a first-line or second-line APL therapy. The estimated annual market potential in the U.S. and Europe for an expanded label including refractory, maintenance and front-line therapy is $150 million.
CytRx also retains an option to expand its licenses for the use of tamibarotene in other fields in oncology, including multiple myeloma, myelodysplastic syndrome and certain solid tumors. Tamibarotene has showed statistically significant anti-tumor activity in an animal trial for multiple myeloma, an incurable malignant tumor of the plasma cells of bone marrow.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of acute promyelocytic leukemia (APL). In addition, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 45% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ: RXII).
Jun 26, 2009 -- Antigen Express Inc., a wholly owned subsidiary of Generex Biotechnology Corporation (Nasdaq: GNBT), has developed new vaccine technology that "could rapidly lead to safe, effective flu vaccines," according to a June 23, 2009 article in the Worcester, Massachusetts Telegram & Gazette.
"It's not a biological process, it's a chemical process," explained Douglas M. Powell, PhD, director of immunobiology at Antigen Express. "It's not futuristic, it's here now."
The article notes that in contrast with traditional vaccines, which require literally cracking millions of hen eggs, Antigen Express uses lab equipment to string together amino acids into peptides that can stimulate the body to produce immune cells in response to specific threats, such as influenza.
"If Antigen Express could develop an H1N1 vaccine, large-scale production could take place rapidly in existing facilities," Dr. Powell said. "The capacity exists now that you could literally make billions of doses of this vaccine."
The complete text of the article is available online at http://www.telegram.com/article/20090623/NEWS/906230410/1116.
Earlier this month, Generex announced positive results of a recently completed Phase I trial of its prostate cancer vaccine. The immunotherapeutic peptide AE37 is also being developed by Antigen Express for multiple cancer indications.
About Generex Biotechnology Corporation
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(tm)), which is available for sale in India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world.
Jun 29, 2009 -- Micro Imaging Technology, Inc. (OTCBB: MMTC) announced that it has entered into a strategic business development relationship with OPH Ltd. Hong Kong who will be instrumental in securing a manufacturing partner for the Company in Asia. In addition, OPH will develop this market for the MIT 1000 Rapid Microbial Identification System through its distribution channels by working closely with existing Micro Imaging Technology (MIT) distributors and jointly with MIT to identify and select other strategic partners to expand the Company's MIT 1000 business in Asia.
"The MIT 1000 technology is truly a revolutionary development in rapid detection of microbial pathogens," said David Harris, chairman of OPH Ltd. Mr. Harris further stated, "We are very pleased and excited to partner with MIT in delivering these exceptional technological benefits to Asian producers and consumers. The speed, accuracy and cost-savings provided by the MIT 1000 System will improve the operational efficiencies and bottom line for food and pharmaceutical manufacturers and, most importantly, will contribute to the advancement of the overall safety of their global supply chains."
MIT recently received Performance Test Method (PTM) Certification for the Identification of Listeria from the AOAC Research Institute (RI) and is now focused on accelerating the commercialization of the MIT 1000. "OPH has helped numerous companies quickly and successfully expand their businesses to Asia. Given our objectives of establishing a global presence and lowering product cost, we see the partnership with OPH as a significant first step in our international growth goals," stated Michael Brennan, MIT's Chairman and CEO.
Recent market research information showed that over $4.5 Billion was spent in 2008 for rapid identification in the industrial microbiology market according to Strategic Consulting Inc. (SCI), and is expected to reach $6.2 Billion by 2013. SCI has provided food processing, beverage, pharmaceutical, personal care and other industries with market metrics for over 20 years.
About OPH Ltd.:
OPH is the parent company to GMC Group Limited management consulting firm, GlobalFinancialWire.com corporate communications service, and UltraFuture public relations service. GMC Group will be taking the lead in coordinating and implementing the strategic planning and business development program. Since 1999, OPH and its affiliates have helped manufacturing and technology companies expand their business in Asia and secure equity funding for expansion. OPH estimates that they have helped companies raise over $15 Million (US) and expand businesses by over $100 Million (US) in that period.
About Micro Imaging Technology:
MIT is a California-based public company that has developed and patented a rapid microbial ID System that can revolutionize the pathogenic ID process and annually save thousands of lives and tens of millions of dollars. The System IDs bacteria in minutes, not days, and at a significant per test cost savings when compared to any conventional method. It does not rely on chemical or biological agents, conventional processing, fluorescent tags, gas chromatography or DNA analysis. The process is totally GREEN requiring only clean water and a sample of the unknown bacteria. Revenues for all rapid testing methods exceed $5 billion annually -- with food safety accounting for over $3.5 billion and are expanding at an average rate of 10.2 percent annually since 2003.
The System is laser based and uses the proven principles of light scattering in conjunction with proprietary PC-based software algorithms to ID microbes and create a proprietary database. MIT, through independent testing, has proven the ability with high accuracy to ID the most dangerous and pervasive pathogens; E. coli, Listeria, Salmonella, and Staphylococcus aureus (a.k.a. Staph) and twenty (20) other species of bacterium.
The MIT 1000 System has numerous ID applications including food quality control, clinical diagnostics, pharmaceutical quality assurance, semiconductor processing control and water quality monitoring. MIT has chosen to focus initial efforts on food quality control as recent events have created an urgent demand for quicker and cheaper testing -- demands that will promote a high-value return on any investment in MIT's technology.
Jun 29, 2009 -- Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and its partner, Antares Pharma, Inc. (NYSE Amex: AIS) today announced the approval of a Supplemental New Drug Application (sNDA), which added "needle-free injection" to its Tev-Tropin(R) [somatropin (rDNA) for injection] brand human growth hormone (hGH) drug label. Teva will market the Antares needle-free device as the Tev-Tropin Tjet Injector system.
"We are pleased to add this new technology to our growing portfolio through our successful partnership with Antares, and to offer patients a less invasive delivery system," stated Larry Downey, head of Teva's North America Brand Pharmaceuticals division. "This significant achievement demonstrates our ability to leverage our leadership in the pharmaceutical industry, and our ongoing commitment to utilize our global strengths in innovative activities."
"This is the first product approval stemming from our portfolio of product collaborations with Teva and is a very exciting milestone for the Company" said Paul K. Wotton, President and Chief Executive Officer of Antares Pharma. "Importantly it is another example of delivering on our strong focus and commitment to patients, together with our partners, to provide new ways to administer drugs. We look forward to the launch of this product by Teva."
Human growth hormone is a protein given by injection that is commonly used to treat children with growth hormone deficiency. Pediatric patients benefit both from the avoidance of using needles as well as the rapid injection speed associated with giving needle-free injections. According to industry estimates, the market for human growth hormone in the United States is approximately $1 billion which is the largest market segment globally. Antares currently markets its needle-free injection system for use in the treatment of growth hormone deficient children through its partners in Europe, Japan and Asia.
About Tev-Tropin(R)
TEV-TROPIN(R) is indicated only for the treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone (GH).
Important Safety Information for Tev-Tropin(R)
TEV-TROPIN(R) stimulates linear growth in children lacking endogenous GH. Treatment of growth hormone-deficient (GHD) children with TEV-TROPIN(R) produces growth rate and IGF-1 levels similar to those seen after treatment with hGH of pituitary origin.
Unless patients with Prader-Willi Syndrome (PWS) also have a diagnosis of GHD, TEV-TROPIN(R) is not indicated for treatment of pediatric patients who have growth failure due to genetically confirmed PWS. Because of reported fatalities, patients with PWS who are severely obese, have severe respiratory impairment, respiratory infections, or sleep apnea should interrupt use of GH.
Patients should be observed for evidence of glucose intolerance, hypopituitarism, malignant transformation of skin lesions, hypothyroidism, slipped capital femoral epiphysis, and intracranial hypertension. Funduscopic examination of patients is recommended at the initiation and periodically during the course of GH treatment. TEV-TROPIN(R) should not be initiated in patients with acute critical illness as a complication of open heart surgery, abdominal surgery, multiple accidental trauma, or those with acute respiratory failure. TEV-TROPIN(R) should not be used in patients with evidence of an active malignancy, progressive or recurrent underlying intracranial tumor, active proliferative or severe nonproliferative diabetic retinopathy, or closed epiphysis.
When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site.
Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis.
Somatropin may alter the clearance of drugs metabolized by the CP450 enzyme system and careful monitoring is advisable.
Benzyl alcohol associated with toxicity in newborns is contained in the diluent supplied with TEV-TROPIN(R). Treatment of patients with coexisting ACTH deficiency should have glucocorticoid replacement dose adjusted to avoid inhibition of growth.
In studies of growth hormone-deficient children, headaches occurred infrequently. Injection-site reactions (eg, pain, bruise) occurred in 8 of the 164 treated patients.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.
About Antares Pharma
Antares Pharma is a product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has multiple development partnerships with leading pharmaceutical companies. The Company's products are designed to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. Antares has three validated drug delivery systems: the ATD(TM) Advanced Transdermal Gel Delivery system; subcutaneous injection technology platforms, including Vibex(TM) disposable pressure-assisted auto injectors, Valeo(TM)/Vision(R) reusable needle-free injectors, and disposable multi-use pen injectors; and Easy Tec(TM) oral disintegrating tablets (ODT). Two of the systems have generated FDA-approved products. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
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