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Generex Biotechnology Corporation (OTCBB: GNBT) $0.29. Today announced two presentations of data obtained from its on-going Phase II trial of its novel immunotherapeutic AE37 vaccine in breast cancer patients. The presentations, entitled Combination Immunotherapy: Safety and Immunologic Data from a Phase II Trial Administering a HER2/neu-derived Peptide Vaccine Sequentially or Concurrently with Trastuzumab and Increased prevalence of HLA-DR3 among breast cancer patients: implications for adjuvant HER2/neu peptide vaccine trials, will be made at the 33rd Annual San Antonio Breast Cancer Symposium in San Antonio, Texas from December 8-12, 2010.
The presentation on combination immunotherapy reports that patients receiving both AE37 and Trastuzumab (Herceptin), a monoclonal antibody targeting the same protein, have increased specific immune-stimulation of T cells when AE37 is given simultaneous to administration of Trastuzumab rather than following Trastuzumab treatment. These results confirm prior published reports suggesting that the combination of Trastuzumab with active immunotherapy can work synergistically in cancer patients.
The second presentation reports that patients who are genetically predisposed to less efficiently recognize peptides derived from the HER2 protein have an immunological response to the AE37 HER2 peptide vaccine that is similar in robustness to the response in patients not having this predisposition. This is promising confirmation that AE37, which is designed as a self-potentiating peptide vaccine, indeed has improved activity that may be clinically relevant.
What They Do: Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies.
Casey Container Corp. (OTCBB: CSEY) $0.32. Today announced it is in receipt of a new purchase order from a U.S.-based bottled water company providing for Casey to supply about 225,000 biodegradable preforms on a weekly basis over a year period, for use in the manufacture of biodegradable plastic bottles. This is the second order received by Casey Container from a bottled water company for its biodegradable plastic bottle solution.
Casey Container holds a license to EcoPure, a revolutionary second-generation proprietary and organic additive, which -- once added to a resin used to produce plastic bottle preforms -- renders the plastic biodegradable. The Company's biodegradable preforms are made of PET, HDPE and other conventional polymers, thus offering the same performance and cost effective advantages of conventional plastics. By introducing EcoPure into the manufacturing process, Casey expects to produce a truly biodegradable PET, HDPE and other polymer products that break down into harmless bio-gases and bio-mass over time in anaerobic environments like landfills.
This order, along with its previous announced preform order also from a bottled water company, set Casey Container on a path to begin producing 450,000 preforms weekly. The combined orders represent over $2 million in revenue to the Company over their first one-year term, based on current pricing for the preforms.
What They Do: Casey Container is engaged in the design and custom manufacture of biodegradable PET, HDPE and other plastic polymer preforms, bottles and containers for use in the bottled water, beverage and consumer products industries.
iBio, Inc. (OTCBB: IBPM) $3.09. Today announced that the U.S. Food and Drug Administration (FDA) accepted another Investigational New Drug (IND) application filed for a product candidate made with the Company’s proprietary, transformative technology, the iBioLaunch technology platform.
The product candidate, H5N1 avian influenza vaccine, funded by the Bill & Melinda Gates Foundation, was manufactured by iBio’s research collaborator, Fraunhofer Center for Molecular Biotechnology (FCMB), in its cGMP robotic pilot manufacturing facility in Newark, Delaware. A human clinical trial based on this IND already has been commenced.
“We are pleased that the FDA again cleared an IND application based on our technology within its thirty-day minimum review period,” said Robert Kay, Chairman and Chief Executive Officer of iBio. “These filings have cumulative importance for us since iBio has rights of access, reference, use and incorporation of the relevant content of these INDs to reduce the time and expense of subsequent applications for regulatory approval of other products, including vaccines and therapeutic biologics, that use the iBioLaunch technology.”
What They Do: iBio is a biotech company commercializing its proprietary, transformative iBioLaunch technology platform for the production of biologics including therapeutic proteins – orphan biologics, biosimilars and biobetters – and vaccines.
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