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lmao..I love this guy. Welcome to Allstocks
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Generex Biotechnology Announces Final Resolution of Sands Litigation
By Market Wire Last Update: 1/13/2006 8:30:02 AM Data provided by
TORONTO, Jan 13, 2006 (MARKET WIRE via COMTEX) -- Generex Biotechnology Corporation (GNBT), a leader in the area of buccal drug delivery, announced today that on January 10, 2006 the Court of Appeals of New York denied a motion by Sands Brothers and Co., Ltd. for leave to appeal the January 23, 2001 and October 29, 2002 decisions and orders of the Appellate Division (First Department). The Appellate Division's October 27, 2002 decision and order affirmed a lower court's order vacating a New York Stock Exchange arbitration panel's award granting Sands Brothers & Co., Ltd. a warrant to purchase 1,530,020 shares of the Company's stock and modified that order by remanding the issue of damages to a new panel of arbitrators expressly limiting damages to reliance damages, which would not include damages for lost profits.
On August 17, 2004, the arbitration panel awarded Sands $150,000 in reliance damages, which award was confirmed by the lower court. In September 2005, Sands Brothers filed a motion seeking leave to appeal to the Court of Appeals of New York. The denial of Sand Brothers' motion lets stand the prior decisions and orders of the Appellate Division vacating the arbitration awards which had granted Sands Brothers a warrant to purchase the Company's stock.
"The decision of the Court of Appeals of New York is a most welcome victory for Generex in this case," stated Anna Gluskin, President & Chief Executive Officer of Generex. "We have vigorously opposed Sands' claim in this case over the past 6 years and are grateful that our position has been vindicated."
About Generex
Generex is engaged in the research and development 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 (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.
For more information, visit the Generex Web site at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
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Looks like this is starting to creep back up.
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New news:
Generex Biotechnology Announces FDA Pre-IND Meeting Scheduled for the Avian Flu Vaccine
By Market Wire Last Update: 1/23/2006 7:30:05 AM Data provided by
TORONTO, Jan 23, 2006 (MARKET WIRE via COMTEX) -- Generex Biotechnology Corporation (GNBT) announced today that Antigen Express, Inc., its wholly owned immunotherapeutics subsidiary, will meet with the U.S. Food and Drug Administration (FDA) on February 10, 2006 to discuss requirements for the filing of an Investigational New Drug (IND) application for the novel Antigen Express vaccine to protect against the H5N1 avian influenza and the commencement of human clinical trials.
A major drawback to current vaccine development efforts is the inability to manufacture enough vaccine in the event of an avian flu pandemic. Current estimates are that the total production capacity of the world for producing an avian flu vaccine using traditional methods is less than 40 million doses, at the cost of several hundred million dollars. A compounding problem in developing vaccines for the avian flu is that two high doses are required to achieve protective immunity given that people have never been exposed to a flu virus similar enough to impart even partial immunological protection.
The great advantage of the Antigen Express vaccine is the ability to induce a strong T-helper cell response using a synthetically manufactured peptide. This is important, as a strong T-helper response plays a major role in helping the body to develop neutralizing antibodies to viral infections. Because the Ii-Key/H5 hybrids can be manufactured synthetically, they are less expensive than cell-culture or hen-egg produced vaccines and it is possible to produce them in much larger quantities quicker in existing facilities. The induction of a good T-helper response is expected to greatly reduce the amount of classically produced vaccine necessary to achieve protective immunity. It is also expected that the Ii-Key/H5 vaccine hybrids will afford some significant degree of protection in humans who have received no other vaccine.
Scientists at Antigen Express are developing a vaccine for the potentially pandemic Asian bird flu (H5N1 strain) utilizing highly conserved fragments of the H5 protein to stimulate potent T-helper cell activity. The H5 fragments are modified using a portion of an immunoregulatory protein (termed Ii-Key) that greatly facilitates their ability to stimulate T-helper cell responses specific to the H5N1 strain. The vaccine peptides have been selected for their likelihood of being both potent and active in more than 80% of the population.
Antigen Express scientists designed and synthesized a panel of 24 Ii-Key/H5 hybrid vaccine peptides, using computer-modeling predictions to identify those with the greatest chance of being active in diverse populations. Recently completed studies demonstrated that T-helper cells from mice immunized with recombinant H5 protein or H5 DNA responded strongly in INF(gamma) and IL-4 ELISPOT assays to three Ii-Key/H5 hybrids, indicating that the natural response to H5 protein involved T-helper cell recognition to three of the H5 peptides we had designed. Subsequent experiments demonstrated that immunization of mice with the three Ii-Key/H5 hybrids alone also lead to strong T cell responses.
About Generex
Generex is engaged in the research and development 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 (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.
For more information, visit the Generex Web site at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Note to Editors: In the fifth paragraph, "(gamma)" is used to represent the gamma symbol, which cannot be transmitted over the wire.
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This one is bouncing this morning after a pull back. This one might stay pretty active considering GNBT has meetings slated for Feb 10th and early March....should be even more news coming out....we'll see. On my radar.
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More news today....thought it was good for the company.
Latest Headline for Generex Biotechnology Cp Del
Generex Biotechnology Announces Interim Results of Clinical Breast Cancer Trials 1/25/2006 8:00:13 AM Collaboration With Walter Reed Army Medical Center Demonstrates Good Response to Novel Peptide Vaccine
TORONTO, Jan 25, 2006 (MARKET WIRE via COMTEX) -- Generex Biotechnology Corporation ( GNBT ) announced today interim results of an ongoing clinical trial designed to assess the safety and immunological potency of a novel peptide vaccine in patients with breast cancer. The therapeutic vaccine is being developed by its wholly owned subsidiary, Antigen Express.
The compound, AE37, is a second-generation peptide vaccine designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene. A significant percentage of breast cancers as well as cancers of the lung, colon, stomach and pancreas express this oncogene. A strong immune response against HER-2/neu offers the potential to kill tumor cells that have spread to parts of the body distant from the primary tumor.
The trials are being conducted at the Walter Reed Army Medical Center (WRAMC) in collaboration with the Clinical Breast Care Project (CBCP). The CBCP is a Congressionally-mandated civilian-military collaboration between WRAMC, the Windber Research Institute (Windber, PA), and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. The mission of the CBCP is to undertake advanced research in breast cancer prevention, diagnosis, and treatment.
Clinical trials were initiated in April of 2005 to establish safety and immunological response to AE37. The trial will include up to 15 patients with stage II breast cancer when completed, including three patients treated at a low dose of peptide (100 micrograms), three at an intermediate dose (500 micrograms), three at a high dose (1000 micrograms) and an additional six at whichever of those doses induces the best immune response in the absence of toxicity. Each dose group will receive six doses of AE37 at monthly intervals. The initial 100 microgram dose group has completed all six vaccinations and all patients developed peptide-specific responses to the immunizing peptide. The response of patients was measured by reactivity of their T cells to AE37 as measured both by their ability to proliferate after being exposed to the peptide and to secrete cytokines. While the proliferation assay showed consistent responses among the patients, the cytokine responses were more variable, with one low responder, one intermediate and one high responder. The responses of patients in the 500 microgram group have come much sooner than was seen in the 100 microgram group. After only two inoculations, the proliferative responses of patients' T cells were 2.7 to 5.7 times the highest levels observed in patients receiving 100 micrograms. In addition, cytokine responses in patients receiving two inoculations in the 500 microgram group were already greater than the highest response observed in any patient of the 100 microgram group. In short, AE37 appears to be safe, well-tolerated and exhibits a dose-dependent immunologic response. Once this initial trial is completed, it is planned to conduct a pivotal trial looking at efficacy with a larger number of breast cancer patients.
Antigen Express is engaged in the development of immunotherapeutic vaccines that stimulate T helper cells. This is accomplished by coupling a small portion of the MHC class II-associated invariant chain (Ii Protein) to a known MHC class II antigenic epitope. The discovery that the resulting 'hybrid' peptide is much more potent than the antigenic epitope alone in stimulating T helper cells forms the basis of a proprietary technology platform at Antigen Express. Hybrid vaccine peptides for the potentially pandemic H5N1 avian influenza virus as well as for HIV using the same platform are also under development.
"The demonstration of biological activity in the clinic is an important milestone for Antigen Express both in terms of product development and as validation for one of their platform technologies," said Anna Gluskin, President & Chief Executive Officer of Generex. "We look forward to further results from these trials and in advancing additional immunotherapeutics based on this technology for oncology and in the area of infectious disease."
About Generex
Generex is engaged in the research and development 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 (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases
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