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GNBT - Generex Biotechnology - Deel 3

703 Posts
Pagina: «« 1 ... 31 32 33 34 35 36 »» | Laatste | Omlaag ↓
  3. welshterrier 5 3 januari 2012 15:20


    Generex Subsidiary Antigen Express Provides Update on AE37 Cancer Vaccine's Clinical & Regulatory Strategy

    Date :

    01/03/2012 @ 9:00AM

    Source :

    PR Newswire

    Stock :

    Generex Biotech Corp (GNBT)

    Quote :

    0.15 0.0 (0.00%) @ 8:51AM



    Generex Subsidiary Antigen Express Provides Update on AE37 Cancer Vaccine's Clinical & Regulatory Strategy

    Print

    Alert

    Generex Biotech Corp (OTCBB:GNBT)
    Intraday Stock Chart

    Today : Tuesday 3 January 2012

    Generex Biotechnology Corporation (OTCBB: GNBT) today provided an update to the clinical development & regulatory strategy for its cancer vaccine, AE37. Positive interim Phase 2b clinical data from the study in HER-2 expressing breast cancer subjects (presented last month at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas) has lead to an earlier-than-expected advancement in the overall development of AE37 for both breast and prostate cancer indications.

    (Logo: photos.prnewswire.com/prnh/20110106/N... )

    AE37 is a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine designed to train the immune system, independent of HLA-type, to track down cancer cells throughout the body and destroy them. The positive interim Phase 2b results, building upon completed pre-clinical and Phase I breast cancer studies, enables Antigen Express to move up the timing of key development and regulatory plans. In particular, the company will organize an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by the end of Q1 2012. With the FDA's guidance, the Company will move into a pivotal Phase 3 clinical development program in women with loco-regional breast cancer that express low to moderate levels of HER2. Parallel steps will be taken with the European Medicines Agency using the same Phase 2b results. The Phase 2b is currently planned to enroll a total of 300 women and will continue as planned to provide additional valuable information on efficacy and safety of AE37 as the Company pursues its Phase 3 trial plans.

    Dr. Eric von Hofe, Ph.D., President of Antigen Express, said: "While the number of patients with recurrent breast cancer is still too low to confirm statistical significance in this ongoing study, the approximate 46% reduction in breast cancer recurrence in low HER2 expressing tumors together with excellent safety enables us to move forward in requesting an End-of-Phase II meeting with the FDA."

    Importantly, the majority of women with loco-regional breast cancer have low to moderate expressing HER2 tumors and currently are treated with chemotherapy and radiotherapy only. There is no approved targeted HER2 therapy for these women.

    "We are excited and committed to move the AE37 cancer vaccine through the appropriate scientific and regulatory steps," commented Mark Fletcher, President & Chief Executive Officer of Generex. "AE37 not only continues to move closer to market approval but also provides validation for the underlying Ii-Key technology platform upon which it is based."

    Phase I studies clearly identified the potential for AE37 to induce the immune system to focus on the HER2 protein through helper (CD4) and cytotoxic (CD8) immune cells in patients. The HER2 protein is expressed on a high percentage of cancers in the breast, prostate, ovaries, gastro-intestinal tract, and lung. In two Phase I trials, AE37 has demonstrated a good safety profile in both breast and prostate cancer patients.

    The AE37 cancer vaccine has also completed a Phase 1 trial in prostate cancer demonstrating appropriate dosing and immune activation similar to that seen in the breast cancer trials. The Phase 2b breast trial results add to AE37's database on tolerability and safety and have raised the possibility of using AE37 early in prostate cancer therapy. With the Phase 2b breast cancer trial suggesting immune activation by AE37 could control breast cancer and seeing similar immune activation in the Phase I prostate trial, the Company is encouraged to move AE37 cancer vaccine more rapidly into larger clinical trials in men with newly diagnosed HER2 positive prostate cancer. These Phase 2 trials are being designed with leading oncologists in prostate cancer.

    About AE37 and Ii-Key Hybrid Platform Technology

    Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for large, unmet medical needs. The Company's Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells. Incorporating the Ii-Key modification along with tumor-associated antigens can greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens as well as increasing immunological memory.

    The first product candidate utilizing the Company's novel Ii-Key Hybrid technology platform is a HER-2/neu Peptide Vaccine (AE37). This "off-the-shelf" cancer immunotherapy product candidate is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a peptide fragment of the human epidermal growth factor receptor 2 (HER2) oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide.

    About Breast Cancer

    According to the American Cancer Society, more than 232,000 women will be diagnosed with breast cancer, and nearly 40,000 will die from the disease, in 2011. For women whose cancer tests positive for increased quantities of the HER2, approved targeted therapies include trastuzumab (Herceptin®; Roche-Genentech). However, only 25% of breast cancer patients have HER2 levels high enough to be eligible for Herceptin. AE37 is positioned initially as an adjuvant therapy for at least 50% of breast cancer patients; i.e., those with low-to-intermediate levels of HER2 expression.

    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™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation in immunotherapy. One of its platform technologies relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

  6. svenhedin 4 januari 2012 22:40
    Generex Subsidiary Antigen Express Available for Partnering & Collaboration Meetings at the 2012 JPMorgan Healthcare Conference

    WORCESTER, Mass. and TORONTO, Jan. 4, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) announced today that representatives of the Company's wholly-owned subsidiary, Antigen Express, Inc., will be in attendance at the 2012 JPMorgan Healthcare Conference in San Francisco from January 8 through 13.

    (Logo: photos.prnewswire.com/prnh/20110106/N... )

    Representatives of Antigen Express will be available over the course of the conference to meet with prospective partners, collaborators, and investors in respect of the Antigen Express proprietary platform immunotherapeutic vaccine technologies.

    Mark Fletcher, Generex President & Chief Executive Officer, has commented: "In particular, the recently announced positive interim clinical data from our Phase 2b study in HER-2 expressing breast cancer subjects makes the time ripe for discussions with prospective partners and collaborations in respect of a Phase 3 study of the breast cancer vaccine."

    Interested parties are invited to contact:

    Mr. Joseph Moscato
    Seahawk Capital Partners, Inc.
    646-599-6222
    jmoscato@seahawkcap.com

    About AE37 and Ii-Key Hybrid Platform Technology

    Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for large, unmet medical needs. The Company's Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells. Incorporating the Ii-Key modification along with tumor-associated antigens can greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens as well as increasing immunological memory.

    The first product candidate utilizing the Company's novel Ii-Key Hybrid technology platform is a HER-2/neu Peptide Vaccine (AE37). This "off-the-shelf" cancer immunotherapy product candidate is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a peptide fragment of the human epidermal growth factor receptor 2 (HER2) oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide.

  8. svenhedin 12 januari 2012 22:08

    Generex Biotechnology and Cannabis Science Look to Make Headway in Lucrative Cancer Drug Market

    Five Star Equities Provides Stock Research on Generex Biotechnology & Cannabis Science

    NEW YORK, NY -- (MARKET WIRE) -- 01/12/12 -- Several small cap biotechnology stocks are looking to make a splash in the highly lucrative cancer drug market this year. According to a recent press release issued by Denver-based Cannabis Science, global cancer drug sales are expected to grow at a compounded annual rate of 12 to 15 percent, reaching $75 to $80 billion by 2012. Five Star Equities examines the outlook for companies in the Biotechnology industry and provides equity research on Generex Biotechnology Corporation (OTCBB: GNBT) and Cannabis Science Inc. (OTCBB: CBIS). Access to the full company reports can be found at:

    www.fivestarequities.com/GNBT

    www.fivestarequities.com/CBIS

    Cannabis Science, Inc. is a development stage company engaged in the development, production, and commercialization of phytocannabinoid-based pharmaceutical products. Last week the company reported the continuing successful progress by two patients who have been topically self-administering Cannabis Science extracts for Squamous Cell Carcinoma Cancer and Skin Cancer.

    Cannabis Science recently issued its fiscal 2012 earnings guidance. The company says sales for 2012 are forecasted to be $6,846,000, while arguing that the company's revenues have "the potential to increase to $65,740,000 in 2014."

    Five Star Equities releases regular market updates on the biotechnology industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.fivestarequities.com and get exclusive access to our numerous stock reports and industry newsletters.

    Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. The Company's novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine (AE37) is the subject of an ongoing Phase 2 clinical study in patients with HER-2 expressing breast cancer. Positive interim results from the ongoing Phase 2 study of AE37 were presented at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in December. The company says that final Phase 2 results are expected at some point this year.

    Five Star Equities provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. Five Star Equities has not been compensated by any of the above-mentioned companies. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: www.fivestarequities.com/disclaimer

    Add to Digg Bookmark with del.icio.us Add to Newsvine

    Contact:
    Five Star Equities
    Email Contact

    Source: Five Star Equities

  10. [verwijderd] 13 januari 2012 23:23
    En ook vandaag weer een mooie 7,5% erbij. Op het hoogste punt gesloten is ook niet slecht, einde van de week.
    Ik ben benieuwd wat er volgende week gaat gebeuren al staan we met de zelfde rotgang mischien wel weer terug op ,008.Who knows @ the end of the day its still GNTB.... init?

    Goed weekend en en de groeten,

    Ronald.
  11. buffalo1 14 januari 2012 10:04
    koersdoel staat op 6 dollar maar dat is relatief,staat al jaren op 6 dollar!!
    Gisteren toch weer plus 7% in een negatieve markt,dromen mag maar ze moeten absoluut een deal sluiten want hun cash is bijna op!!
    Dus in een sterke onderhandelpositie zitten ze niet,denk eerder aan een overname.............
    Niet vergeten dat de laatste tijd een pak biotech in Amerika overgenomen is met een goed product in fase 2,en dat hebben ze want AE37 blijkt volgens de meeste waarnemers revolutionair te zijn.............
    Het aandeel is wel HOT op het moment bijna maal 3,5 op 7 weken kan tellen!!
  13. svenhedin 17 januari 2012 15:47
    Generex Subsidiary Antigen Express Featured on SNN Stock News Now; Highlights Advantages of Ii-Key Platform Technology for Cancer Immunotherapy

    WORCESTER, Mass. and TORONTO, Jan. 17, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today that a detailed interview conducted at the BioTech Showcase 2012 during last week's JPMorgan Healthcare Conference in San Francisco with Dr. Eric von Hofe, Ph.D., President of Generex subsidiary Antigen Express, Inc., regarding the Antigen Express breast cancer vaccine, is available on the Stock News Now website (www.stocknewsnow.com) and on the Generex website (www.generex.com).

    The company further outlined advantages of the Ii-Key immunotherapeutic vaccine. This comes in the wake of positive interim data from its Phase 2b breast cancer trial announced last month at the San Antonio Breast Cancer Symposium.

    One of the core platform technologies of Antigen Express was obtained through seminal discoveries by the founder of the company, Dr. Robert Humphries. As one of the first to characterize MHC class II molecules, he spent a large part of his career elucidating the mechanism of antigenic peptide charging of MHC class II molecules and presentation to CD4+ T helper cells. In particular, he showed that a portion of an MHC class II cofactor controlled antigenic peptide loading onto the class II molecule. It was immediately clear that this represented a simple yet highly effective means of controlling the activation of CD4+ T cells.

    Ii-Key, as this portion of the MHC class II cofactor was termed, provides a robust means for causing MHC class II molecules to either spill antigens causing a harmful autoimmune responses (such as in multiple sclerosis, rheumatoid arthritis or Type I diabetes) or, when linked to an antigen, an activating response triggering a potent immune response. For this latter application, Ii-Key has been linked to a variety of antigens (e.g., portions of viral proteins or proteins expressed in cancer cells) to produce a more robust yet specific activating immune response. Broad patent protection has been allowed for the various functional activities of Ii-Key.

    The most advanced Ii-Key compound currently under development is AE37, which contains a portion of the tumor-associated HER2 protein linked to Ii-Key. In a number of preclinical studies, AE37 has shown clearly increased potency over the unmodified HER2 peptide, consistent with the increased activity of a variety of other Ii-Key containing peptides that have been investigated. Of perhaps greatest interest is the observation that AE37 produced a robust and specific immunological response in a Phase I trial in the absence of immunological adjuvant. This is in clear contrast to most other peptide vaccines that are being developed.

    The recently reported interim results of a randomized, controlled Phase 2b trial showing a strong trend toward decreased relapse in patients receiving AE37 is consistent both with the increased immunological activity of AE37 as well as a variety of studies in the field of cancer immunotherapy showing the importance of specific CD4+ T helper cell activation in generating an effective anti-cancer immune response. While the anti-HER2 therapeutic Herceptin has been shown to significantly reduce relapse in breast cancer patients, it can only be used in roughly 25% of patients whose tumors express the highest level of the HER2 protein. AE37, in contrast, is applicable for use in patients whose tumors express lower levels of HER2. This population, which is ineligible for Herceptin, represents approximately 50% of breast cancer patients.

    About AE37 and Ii-Key Hybrid Platform Technology

    Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for large, unmet medical needs. The Company's Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells. Incorporating the Ii-Key modification along with tumor-associated antigens can greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens as well as increasing immunological memory.

    The first product candidate utilizing the Company's novel Ii-Key Hybrid technology platform is a HER-2/neu Peptide Vaccine (AE37). This "off-the-shelf" cancer immunotherapy product candidate is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a peptide fragment of the human epidermal growth factor receptor 2 (HER2) oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide.

    About Breast Cancer

    According to the American Cancer Society, more than 232,000 women will be diagnosed with breast cancer, and nearly 40,000 will die from the disease, in 2011. For women whose cancer tests positive for increased quantities of the HER2, approved targeted therapies include trastuzumab (Herceptin®; Roche-Genentech). However, only 25% of breast cancer patients have HER2 levels high enough to be eligible for Herceptin. AE37 is positioned initially as an adjuvant therapy for at least 50% of breast cancer patients; i.e., those with low-to-intermediate levels of HER2 expression.

    About Generex Biotechnology Corporation

703 Posts
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