gnbt - momento da verdade
Então Generex.... estamos à espera....
Não estamos em Julho????
Ver:
Active Comparator Study of Generex Oral-Lyn™ Spray and Injected Human Insulin
Status: Recruiting
Study State Date: April 2008
Primary Completion Date: Anticipated July 2010
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Phase: Phase 3
Sponsor(s): Generex Biotechnology Corp.
OSMOS Clinical Research, Inc
Information By: Generex Biotechnology Corp.
Trial Identifier: NCT00668850
Official Title: A 26-Week, Open-Label, Randomized, Active Comparator Study of Generex Oral-Lyn™ Spray and Injected Human Insulin In Subjects With Type-1 Diabetes Mellitus
Description: To compare the efficacy of Generex Oral-lyn™ RapidMist™ System and standard regular human insulin therapy as measured by HbA1c, in type-1 diabetes mellitus subjects on BID NPH intermediate acting insulin therapy.
http://www.clinicaltrialssearch.org/act ... 68850.html
Não estamos em Julho????
Ver:
Active Comparator Study of Generex Oral-Lyn™ Spray and Injected Human Insulin
Status: Recruiting
Study State Date: April 2008
Primary Completion Date: Anticipated July 2010
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Phase: Phase 3
Sponsor(s): Generex Biotechnology Corp.
OSMOS Clinical Research, Inc
Information By: Generex Biotechnology Corp.
Trial Identifier: NCT00668850
Official Title: A 26-Week, Open-Label, Randomized, Active Comparator Study of Generex Oral-Lyn™ Spray and Injected Human Insulin In Subjects With Type-1 Diabetes Mellitus
Description: To compare the efficacy of Generex Oral-lyn™ RapidMist™ System and standard regular human insulin therapy as measured by HbA1c, in type-1 diabetes mellitus subjects on BID NPH intermediate acting insulin therapy.
http://www.clinicaltrialssearch.org/act ... 68850.html
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
...Business Opportunity as of August 31st ....
o que será que a generex quer dizer com isto.....
Ver.
Dia 15 de Julho de 2010
http://biz.yahoo.com/e/100715/gnbt8-k.html
o que será que a generex quer dizer com isto.....
Ver.
Dia 15 de Julho de 2010
http://biz.yahoo.com/e/100715/gnbt8-k.html
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
pedro200 Escreveu:pedro200 Escreveu:Ver página 7 - 12 (AE37 Cancer Vaccine)
http://www.health.mil/Libraries/Documen ... he-MHS.pdf
That particular breast cancer vaccine trial has just been cleared by the FDA to enter phase three: a greatly expanded cohort that receives vaccines blindly. Some will receive the new cancer vaccine, while others will receive a more generic immune stimulant. Ideally, because the cancer vaccine is targeted to activate the immune system against specific types of cancerous cells, it will be more effective than the immune stimulant. Neither doctor nor patient knows which subjects have received the active specific immunotherapy and which have received a non-specific type.
If phase three goes as well as expected, the breast cancer vaccine could be on the market in five years, approved to reduce the risk of recurrence in women who have successfully fought off breast cancer.
Peoples hopes that the breast cancer vaccines he is researching will someday be used as a preventive tool. “To see things that you discover in the lab actually being translated into clinical trials and ultimately—hopefully in my lifetime—into an approved therapeutic for cancer would be the ultimate achievement,” he says. Once it is cleared for use as a drug that reduces recurrence, Peoples will lead the CVDP in testing it as a drug that can prevent cancer all together.
Este documento contém informação melhor que muitas Press Release da Generex! O Ae37 está na fase III? hum... a gnbt já divulgou isto?

nas propriedades do pdf diz que este foi criado em 29 de junho de 2010 às 21h37m20s ...

Boa semana
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
pedro200 Escreveu:Ver página 7 - 12 (AE37 Cancer Vaccine)
http://www.health.mil/Libraries/Documen ... he-MHS.pdf
That particular breast cancer vaccine trial has just been cleared by the FDA to enter phase three: a greatly expanded cohort that receives vaccines blindly. Some will receive the new cancer vaccine, while others will receive a more generic immune stimulant. Ideally, because the cancer vaccine is targeted to activate the immune system against specific types of cancerous cells, it will be more effective than the immune stimulant. Neither doctor nor patient knows which subjects have received the active specific immunotherapy and which have received a non-specific type.
If phase three goes as well as expected, the breast cancer vaccine could be on the market in five years, approved to reduce the risk of recurrence in women who have successfully fought off breast cancer.
Peoples hopes that the breast cancer vaccines he is researching will someday be used as a preventive tool. “To see things that you discover in the lab actually being translated into clinical trials and ultimately—hopefully in my lifetime—into an approved therapeutic for cancer would be the ultimate achievement,” he says. Once it is cleared for use as a drug that reduces recurrence, Peoples will lead the CVDP in testing it as a drug that can prevent cancer all together.
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
pedro200 Escreveu:Sanofi said to be planning $20bn acquisition in US
By Gareth Macdonald, 05-Jul-2010
Related topics: Mergers and acquisitions, Industry Drivers
Rumour has it that French drug giant Sanofi Aventis is planning to make a $20bn (€16bn) acquisition in the US with speculation that biotechs like Allergan, Biogen Idec and Genzyme are among the targets.
The speculation was sparked by a Bloomberg report late last week which stated that, according to unnamed sources, Sanofi’s board has met to consider a potential billion dollar US takeover.
While Sanofi has not commented, most observers agree that such an acquisition would be in keeping with the strategy CEO Christopher Viehbacher has employed since his appointment in 2008, which has seen the firm spend $17bn on 25 acquisitions.
In the last few weeks for example Sanofi bought US biopharmaceutical company Targegen, which is a developer of small molecule kinase inhibitors. And, while the Targegen deal's $560m value would be dwarfed by the rumoured takover, it does indicate that Sanofi is still looking to grow through acquisitions.
In addition, a large-scale acquisition would also fit with the general trend that has seen a number of Sanofi’s Big Pharma peers spend on M&A to replenish revenue from patent threatened products.
Sanofi to supply insulin to Generex
By Nick Taylor, 10-Dec-2009
Related topics: Materials & Formulation, Contract services (outsourcing), Drug delivery systems, Ingredients, excipients and raw materials
Sanofi-Aventis will manufacture and supply recombinant human insulin crystals to Generex Biotechnology for use in Oral-lyn commercial production and clinical trials.
Oral-lyn, Generex’s liquid formulation of regular human insulin delivered to the buccal mucosa, is commercially available in India, Lebanon, Algeria and Ecuador and Phase III type 1 diabetes trials are ongoing at several sites.
To support attempts to gain regulatory approval in major markets, including the US and Canada, Generex has entered into an active pharmaceutical ingredient (API) supply agreement with Sanofi.
"We are very pleased to have entered into this long-term supply agreement for insulin crystal," said Anna Gluskin, Generex's president and CEO.
Gluskin added: "It solidifies one of our key product components which will assist in the smooth transition into commercialisation of our flagship product, Generex Oral-lyn, into major markets.”
The insulin will be manufactured at Sanofi’s site in Frankfurt, Germany. Since the end of the 1990s the site has developed pilot and commercial scale production of human recombinant insulin from a genetically modified Escherichia coli strain.
In addition to gaining an API supply Generex will also receive quality and regulatory support from Sanofi. Generex’s regulatory team will now begin updating current regulatory submissions to include Sanofi’s insulin crystal.
“A new paradigm”
Gluskin explained that Generex is seeking “to establish a new paradigm for the treatment of diabetes” by gaining regulatory approval for Oral-lyn in major pharmaceutical markets.
The company believes its product “is a safe, simple, fast, effective, and pain-free alternative to subcutaneous injections of prandial insulin” which, unlike inhaled insulin products, has no pulmonary deposition.
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
Sanofi said to be planning $20bn acquisition in US
By Gareth Macdonald, 05-Jul-2010
Related topics: Mergers and acquisitions, Industry Drivers
Rumour has it that French drug giant Sanofi Aventis is planning to make a $20bn (€16bn) acquisition in the US with speculation that biotechs like Allergan, Biogen Idec and Genzyme are among the targets.
The speculation was sparked by a Bloomberg report late last week which stated that, according to unnamed sources, Sanofi’s board has met to consider a potential billion dollar US takeover.
While Sanofi has not commented, most observers agree that such an acquisition would be in keeping with the strategy CEO Christopher Viehbacher has employed since his appointment in 2008, which has seen the firm spend $17bn on 25 acquisitions.
In the last few weeks for example Sanofi bought US biopharmaceutical company Targegen, which is a developer of small molecule kinase inhibitors. And, while the Targegen deal's $560m value would be dwarfed by the rumoured takover, it does indicate that Sanofi is still looking to grow through acquisitions.
In addition, a large-scale acquisition would also fit with the general trend that has seen a number of Sanofi’s Big Pharma peers spend on M&A to replenish revenue from patent threatened products.
By Gareth Macdonald, 05-Jul-2010
Related topics: Mergers and acquisitions, Industry Drivers
Rumour has it that French drug giant Sanofi Aventis is planning to make a $20bn (€16bn) acquisition in the US with speculation that biotechs like Allergan, Biogen Idec and Genzyme are among the targets.
The speculation was sparked by a Bloomberg report late last week which stated that, according to unnamed sources, Sanofi’s board has met to consider a potential billion dollar US takeover.
While Sanofi has not commented, most observers agree that such an acquisition would be in keeping with the strategy CEO Christopher Viehbacher has employed since his appointment in 2008, which has seen the firm spend $17bn on 25 acquisitions.
In the last few weeks for example Sanofi bought US biopharmaceutical company Targegen, which is a developer of small molecule kinase inhibitors. And, while the Targegen deal's $560m value would be dwarfed by the rumoured takover, it does indicate that Sanofi is still looking to grow through acquisitions.
In addition, a large-scale acquisition would also fit with the general trend that has seen a number of Sanofi’s Big Pharma peers spend on M&A to replenish revenue from patent threatened products.
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
Generex's Glucose RapidSpray(TM) Now Available at Boots UK R
http://finance.yahoo.com/news/Generexs- ... l?x=0&.v=1
WORCESTER, Mass., July 15, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT - News) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that one of its proprietary confectionary over-the-counter products, Glucose RapidSpray(TM), is now available under a trial run at selected Boots UK (www.Boots-UK.com) retail chain stores.
Boots is a member of Alliance Boots (www.allianceboots.com) and has approximately 2600 stores, from local community pharmacies to large destination health and beauty stores. Alliance Boots is a leading international, pharmacy-led health and beauty group delivering a range of products and services to customers.
Glucose RapidSpray(TM) (www.GlucoseRapidSpray.com) is a proprietary, innovative alternative for people who require or want additional glucose. Glucose RapidSpray(TM) delivers a fat-free, low-calorie glucose formulation that was developed using the Company's proprietary buccal drug delivery technologies. Glucose RapidSpray(TM) delivers glucose directly into the mouth where it is absorbed. Glucose RapidSpray(TM) is simple to carry and use with no large tablets to chew or messy gels to swallow.
Presently, Glucose RapidSpray(TM) is available in retail pharmacies across Canada, the United States and in independent stores and pharmacies in the Middle East. The processes for registering the product for retail marketing in other countries is underway.
Glucose RapidSpray(TM) was introduced to Boots UK through the Boots Centre for Innovation (www.BootsInnovation.com). Established in 2007, Boots Centre for Innovation has been set up to work closely with early stage companies or inventors to develop pioneering products for the shelves of Alliance Boot stores. Boots Centre for Innovation is a not-for-profit partnership between Alliance Boots, Longbow Capital and The Institute of Life Science at Swansea University.
"We welcome the opportunity to have our proprietary product, Glucose RapidSpray(TM), become available in the UK," said Rose C. Perri, Generex's Chief Operating Officer. "We remain confident that customers of this confectionary over-the-counter product will be satisfied with its results."
WORCESTER, Mass., July 15, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT - News) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that one of its proprietary confectionary over-the-counter products, Glucose RapidSpray(TM), is now available under a trial run at selected Boots UK (www.Boots-UK.com) retail chain stores.
Boots is a member of Alliance Boots (www.allianceboots.com) and has approximately 2600 stores, from local community pharmacies to large destination health and beauty stores. Alliance Boots is a leading international, pharmacy-led health and beauty group delivering a range of products and services to customers.
Glucose RapidSpray(TM) (www.GlucoseRapidSpray.com) is a proprietary, innovative alternative for people who require or want additional glucose. Glucose RapidSpray(TM) delivers a fat-free, low-calorie glucose formulation that was developed using the Company's proprietary buccal drug delivery technologies. Glucose RapidSpray(TM) delivers glucose directly into the mouth where it is absorbed. Glucose RapidSpray(TM) is simple to carry and use with no large tablets to chew or messy gels to swallow.
Presently, Glucose RapidSpray(TM) is available in retail pharmacies across Canada, the United States and in independent stores and pharmacies in the Middle East. The processes for registering the product for retail marketing in other countries is underway.
Glucose RapidSpray(TM) was introduced to Boots UK through the Boots Centre for Innovation (www.BootsInnovation.com). Established in 2007, Boots Centre for Innovation has been set up to work closely with early stage companies or inventors to develop pioneering products for the shelves of Alliance Boot stores. Boots Centre for Innovation is a not-for-profit partnership between Alliance Boots, Longbow Capital and The Institute of Life Science at Swansea University.
"We welcome the opportunity to have our proprietary product, Glucose RapidSpray(TM), become available in the UK," said Rose C. Perri, Generex's Chief Operating Officer. "We remain confident that customers of this confectionary over-the-counter product will be satisfied with its results."
- Mensagens: 577
- Registado: 1/9/2009 10:52
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if Generex were to become a large revenue generating company through the success of Generex Oral-lyn™, and its delivery method was also validated by use with other drug therapies, it would be then be possible for Generex to create a host of “super generic” drugs using its proprietary RapidMist™ drug delivery method and needing only to demonstrate bioequivalence, opening further multibillion dollar opportunities. Now of course this would be down the road a ways and a good many things would need to go in our favor for this to become a reality. However, it is not inconceivable that a multibillion dollar broad based drug company can grow out of our small and relatively unknown Company.
I chose to be the Chief Scientific Advisor to Generex because of the vast potential I see for the technologies and science possessed by this Company. People have called me “The Grandfather of the Industry” or “The Sage of Biotech” but in the end, I am just a researcher and an entrepreneur at heart. I see Generex as an opportunity for me to stay on the biotechnology rollercoaster which I love and ride it to a multibillion dollar success as everyone at the Company works diligently to have a positive impact on the lives of people with diabetes, cancers, influenzas or the many other diseases we may address down the road.
By Dr. Joseph Rubinfeld, Chief Scientific Advisor
(salvo erro este senhor foi um dos fundadores da AMGEN!)
January 08, 2010
I chose to be the Chief Scientific Advisor to Generex because of the vast potential I see for the technologies and science possessed by this Company. People have called me “The Grandfather of the Industry” or “The Sage of Biotech” but in the end, I am just a researcher and an entrepreneur at heart. I see Generex as an opportunity for me to stay on the biotechnology rollercoaster which I love and ride it to a multibillion dollar success as everyone at the Company works diligently to have a positive impact on the lives of people with diabetes, cancers, influenzas or the many other diseases we may address down the road.
By Dr. Joseph Rubinfeld, Chief Scientific Advisor
(salvo erro este senhor foi um dos fundadores da AMGEN!)
January 08, 2010
- Mensagens: 577
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pedro200 Escreveu:Lembram-se de eu ter falado da reunião do dia 10 de Junho com o Nasdaq?
A Generex acaba de divulgar a seguinte informação::)
Com esta autorização a generex ganha tempo.... os stockholders até podem aprovar o reserve-split, mas este até pode nunca acontecer....
Mais uma boa notícia...aguardemos próximos desenvolvimentos.....
http://biz.yahoo.com/e/100715/gnbt8-k.html
15-Jul-2010
Other Events
Item 8.01. Other Events.
On July 9, 2010, Generex Biotechnology Corporation (the "Company") received written notice that a Nasdaq Hearings Panel (the "Panel") had determined to grant the request of the Company to remain listed on The Nasdaq Stock Market, subject to certain conditions. These conditions include: (1) the Company informing the Panel on or about July 28, 2010 that it has obtained shareholder approval to implement a reverse stock split in a ratio sufficient to meet the $1.00 bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2); and (2) the Company informing the Panel on or about August 31, 2010 whether it has a signed term sheet in respect of a material business opportunity (a "Business Opportunity"). If the Company does not have a signed term sheet for a Business Opportunity as of August 31st, the Company must implement the reverse stock split and demonstrate a closing bid price for its common stock of $1.00 per share or more for a minimum of ten consecutive trading days on or before September 30, 2010 to regain compliance with Nasdaq's bid price requirement and avoid delisting. If the Company does have a signed term sheet for a Business Opportunity by August 31st, the Company must provide the Panel with an update on its stock price and trend, recent public disclosures, and a timeline for either signing and announcing an agreement relating to a Business Opportunity or, alternatively, implementing a reverse stock split, along with other factors for the Panel to consider in determining whether and for how long to continue the Company's listing; upon the Company's submission of such information, the Panel will then evaluate the Company's request for continued listing through October 2010.
During the granted exception period, the Company must promptly notify the Panel of any significant developments, particularly any event, condition or circumstance that may impact its ability to maintain compliance with any Nasdaq listing requirement or the exception deadline. The Panel reserves the right to reconsider the granted exception in such an instance.
The foregoing disclosures relating to a Business Opportunity are presented solely for the purpose of describing the Panel's determination with respect to the Company's continued listing on Nasdaq. Nothing in this Current Report on Form 8-K should be construed to indicate that a Business Opportunity will, or is likely to, occur, or that if it should occur, it will be material to, or have any effect on, the Company's business, prospects or finances.
I am pleased to see that the Panel recognized the opportunities available to the Company through prospective business events and gave us the opportunity to remain listed on The NASDAQ Stock Market," said Anna Gluskin, the Company's President & Chief Executive Officer. "We are looking forward to our upcoming annual meeting of the Generex stockholders and the prospect of an exciting and positive year ahead."

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Lembram-se de eu ter falado da reunião do dia 10 de Junho com o Nasdaq?
A Generex acaba de divulgar a seguinte informação:
:)
Com esta autorização a generex ganha tempo.... os stockholders até podem aprovar o reserve-split, mas este até pode nunca acontecer....
Mais uma boa notícia...aguardemos próximos desenvolvimentos.....
http://biz.yahoo.com/e/100715/gnbt8-k.html
15-Jul-2010
Other Events
Item 8.01. Other Events.
On July 9, 2010, Generex Biotechnology Corporation (the "Company") received written notice that a Nasdaq Hearings Panel (the "Panel") had determined to grant the request of the Company to remain listed on The Nasdaq Stock Market, subject to certain conditions. These conditions include: (1) the Company informing the Panel on or about July 28, 2010 that it has obtained shareholder approval to implement a reverse stock split in a ratio sufficient to meet the $1.00 bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2); and (2) the Company informing the Panel on or about August 31, 2010 whether it has a signed term sheet in respect of a material business opportunity (a "Business Opportunity"). If the Company does not have a signed term sheet for a Business Opportunity as of August 31st, the Company must implement the reverse stock split and demonstrate a closing bid price for its common stock of $1.00 per share or more for a minimum of ten consecutive trading days on or before September 30, 2010 to regain compliance with Nasdaq's bid price requirement and avoid delisting. If the Company does have a signed term sheet for a Business Opportunity by August 31st, the Company must provide the Panel with an update on its stock price and trend, recent public disclosures, and a timeline for either signing and announcing an agreement relating to a Business Opportunity or, alternatively, implementing a reverse stock split, along with other factors for the Panel to consider in determining whether and for how long to continue the Company's listing; upon the Company's submission of such information, the Panel will then evaluate the Company's request for continued listing through October 2010.
During the granted exception period, the Company must promptly notify the Panel of any significant developments, particularly any event, condition or circumstance that may impact its ability to maintain compliance with any Nasdaq listing requirement or the exception deadline. The Panel reserves the right to reconsider the granted exception in such an instance.
The foregoing disclosures relating to a Business Opportunity are presented solely for the purpose of describing the Panel's determination with respect to the Company's continued listing on Nasdaq. Nothing in this Current Report on Form 8-K should be construed to indicate that a Business Opportunity will, or is likely to, occur, or that if it should occur, it will be material to, or have any effect on, the Company's business, prospects or finances.
A Generex acaba de divulgar a seguinte informação:

Com esta autorização a generex ganha tempo.... os stockholders até podem aprovar o reserve-split, mas este até pode nunca acontecer....
Mais uma boa notícia...aguardemos próximos desenvolvimentos.....
http://biz.yahoo.com/e/100715/gnbt8-k.html
15-Jul-2010
Other Events
Item 8.01. Other Events.
On July 9, 2010, Generex Biotechnology Corporation (the "Company") received written notice that a Nasdaq Hearings Panel (the "Panel") had determined to grant the request of the Company to remain listed on The Nasdaq Stock Market, subject to certain conditions. These conditions include: (1) the Company informing the Panel on or about July 28, 2010 that it has obtained shareholder approval to implement a reverse stock split in a ratio sufficient to meet the $1.00 bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2); and (2) the Company informing the Panel on or about August 31, 2010 whether it has a signed term sheet in respect of a material business opportunity (a "Business Opportunity"). If the Company does not have a signed term sheet for a Business Opportunity as of August 31st, the Company must implement the reverse stock split and demonstrate a closing bid price for its common stock of $1.00 per share or more for a minimum of ten consecutive trading days on or before September 30, 2010 to regain compliance with Nasdaq's bid price requirement and avoid delisting. If the Company does have a signed term sheet for a Business Opportunity by August 31st, the Company must provide the Panel with an update on its stock price and trend, recent public disclosures, and a timeline for either signing and announcing an agreement relating to a Business Opportunity or, alternatively, implementing a reverse stock split, along with other factors for the Panel to consider in determining whether and for how long to continue the Company's listing; upon the Company's submission of such information, the Panel will then evaluate the Company's request for continued listing through October 2010.
During the granted exception period, the Company must promptly notify the Panel of any significant developments, particularly any event, condition or circumstance that may impact its ability to maintain compliance with any Nasdaq listing requirement or the exception deadline. The Panel reserves the right to reconsider the granted exception in such an instance.
The foregoing disclosures relating to a Business Opportunity are presented solely for the purpose of describing the Panel's determination with respect to the Company's continued listing on Nasdaq. Nothing in this Current Report on Form 8-K should be construed to indicate that a Business Opportunity will, or is likely to, occur, or that if it should occur, it will be material to, or have any effect on, the Company's business, prospects or finances.
- Mensagens: 577
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- Localização: 7
Mary Crowley Cancer Research Centers offers patients access to innovative clinical trials under the oversight of the FDA, using new therapies targeting the molecular pathways that impact cancer growth
http://www.marycrowleymedicalresearch.c ... q=node/490
You are asked to be in this study because you have intermediate to high risk breast cancer or ovarian cancer and you have no evidence of cancer after surgical and chemotherapy treatments. The purpose of this study is to test an investigational agent called GP2 + GM-CSF and AE37 + GM-CSF vaccines. GP2 and AE37 are made up of two peptides (fragments of proteins). The peptides are combined with another product, granulocyte-macrophage colony-stimulating factor (GM-CSF), called an "adjuvant" that is meant to enhance the response of the immune system. The peptides in this investigational drug are designed to help your immune system make a type of white blood cell, within the immune system, called "cytotoxic" or "killer" T-cell. Cytoxic T-cells attack particular cancer cells that have specific markers called "antigens." The antigens targeted by this investigational drug are known as "HER-2/neu." Each of these peptides has separately been preliminarily tested as a vaccine with GM-CSF in patients with breast cancer; this study will test the combination of the peptides when given at the same time.
Inclusion Criteria
Intermediate- to high-risk patients with breast cancer.For the purposes of this protocol, these groups are defined as including any patient with clinical and/or molecular prognostic indicators warranting chemotherapy AND/OR
Stage IIIC or IV ovarian cancer patients following optimal debulking surgery and chemotherapy
HER2/neu-expressing tumor (IHC 1-3+ and/or positive FISH >0
Platelets > 100,000 mm3
HLA-A2+ or HLA-A3+.
Age >18 years
Completion of primary standard of care breast and/or ovarian cancer therapies (i.e., surgery, chemotherapy, immunotherapy (e.g., trastuzumab) and radiation therapy as appropriate per standard of care for patients’ specific cancer). Patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.
Exclusion Criteria
HER2/neu- breast/ovarian cancers (IHC 0).
Patients who are candidates for the following protocol; “Prospective, randomized, single-blinded, multi-center phase II trial of the HER2/neu peptide GP2 + GM-CSF vaccine versus GM-CSF alone in HLA-A2+ OR the modified HER2/neu peptide AE37 + GM-CSF vaccine versus GM-CSF alone in HLA-A2- node positive and high-risk node-negative breast cancer patients to prevent recurrence” will be enrolled to that study.
Clinical and/or radiographic evidence of residual or persistent breast cancer or ovarian cancer
Receiving immunosuppressive therapy to include chemotherapy, steroids (note: the use of prednisone, or equivalent, <2.0mg/day, is allowed) or methotrexate. Except patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.
Laboratory values in the following ranges: Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000
Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
Patients may not be receiving any other investigational agents (except with permission of the Lead Principal Investigator)
http://www.marycrowleymedicalresearch.c ... q=node/490
You are asked to be in this study because you have intermediate to high risk breast cancer or ovarian cancer and you have no evidence of cancer after surgical and chemotherapy treatments. The purpose of this study is to test an investigational agent called GP2 + GM-CSF and AE37 + GM-CSF vaccines. GP2 and AE37 are made up of two peptides (fragments of proteins). The peptides are combined with another product, granulocyte-macrophage colony-stimulating factor (GM-CSF), called an "adjuvant" that is meant to enhance the response of the immune system. The peptides in this investigational drug are designed to help your immune system make a type of white blood cell, within the immune system, called "cytotoxic" or "killer" T-cell. Cytoxic T-cells attack particular cancer cells that have specific markers called "antigens." The antigens targeted by this investigational drug are known as "HER-2/neu." Each of these peptides has separately been preliminarily tested as a vaccine with GM-CSF in patients with breast cancer; this study will test the combination of the peptides when given at the same time.
Inclusion Criteria
Intermediate- to high-risk patients with breast cancer.For the purposes of this protocol, these groups are defined as including any patient with clinical and/or molecular prognostic indicators warranting chemotherapy AND/OR
Stage IIIC or IV ovarian cancer patients following optimal debulking surgery and chemotherapy
HER2/neu-expressing tumor (IHC 1-3+ and/or positive FISH >0
Platelets > 100,000 mm3
HLA-A2+ or HLA-A3+.
Age >18 years
Completion of primary standard of care breast and/or ovarian cancer therapies (i.e., surgery, chemotherapy, immunotherapy (e.g., trastuzumab) and radiation therapy as appropriate per standard of care for patients’ specific cancer). Patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.
Exclusion Criteria
HER2/neu- breast/ovarian cancers (IHC 0).
Patients who are candidates for the following protocol; “Prospective, randomized, single-blinded, multi-center phase II trial of the HER2/neu peptide GP2 + GM-CSF vaccine versus GM-CSF alone in HLA-A2+ OR the modified HER2/neu peptide AE37 + GM-CSF vaccine versus GM-CSF alone in HLA-A2- node positive and high-risk node-negative breast cancer patients to prevent recurrence” will be enrolled to that study.
Clinical and/or radiographic evidence of residual or persistent breast cancer or ovarian cancer
Receiving immunosuppressive therapy to include chemotherapy, steroids (note: the use of prednisone, or equivalent, <2.0mg/day, is allowed) or methotrexate. Except patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.
Laboratory values in the following ranges: Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000
Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
Patients may not be receiving any other investigational agents (except with permission of the Lead Principal Investigator)
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A GNBT está no AH a 0.39 com um volume já algo considerável acima da média de 29,540, tendo tocado também nos 0.40:
http://www.nasdaq.com/aspxcontent/Exten ... type=after
http://www.nasdaq.com/aspxcontent/Exten ... type=after
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a cotada hoje esteve um bocadinho "flat", subiu os 3% da ordem, faltando ainda quebrar os 0.38, não esquecer que salvo erro é a 5ª sessão consecutiva a subir, a juntar ao resto das noticias e dos indicadores favoráveis, acho que estamos no bom caminho.
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AC a GNBT fez 800 usd negociados no after-hours!
esta acção continua a ser alvo de um absoluto wishfull thinking !
a todos os que não são habituais neste tópico sou a alertar para a perigosidade desta acção...
eu negoceio-a, mas o dinheiro que lá meto não é relevante. e o perigo dá-me algum prazer.
esta acção continua a ser alvo de um absoluto wishfull thinking !
a todos os que não são habituais neste tópico sou a alertar para a perigosidade desta acção...
eu negoceio-a, mas o dinheiro que lá meto não é relevante. e o perigo dá-me algum prazer.
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Será efeito Intel ?



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AC Investor Blog
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Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
www.ac-investor.blogspot.com -
Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
Dia 10 de Maio de 2010, a generex divulgou esta informação:
Generex will continue to monitor and execute the ongoing Generex Oral-lyn(TM) study according to protocol and national/international ICH-GCPs. The study's endpoint is for Generex Oral-lyn(TM) to achieve non-inferiority to injectable meal-time (prandial) insulin. Formal verification of the non-inferiority hypothesis should be achieved by the statistical power set out in the protocol. Following the execution of the study's first interim analysis in approximately two months, the enrollment of additional subjects in the study may possibly be terminated. This in turn would establish an approximate end-of-study-treatment-period in December 2010.
To date, no Generex Oral-lyn(TM) drug-related "Serious Adverse Events" (SAEs) have been reported, which also supports the current initiatives of the study.
2 meses depois......
(hoje é dia 13 de Julho)
olhem para aquilo que aconteceu no dia 5 de junho de 2009 à cotação da generex, quando esta divulgou os resultados do oral lyn, conhecidos à data.
Jun 5, 2009 0.85 1.14 0.72 0.81 75,070,400 0.81
Jun 4, 2009 0.50 0.87 0.49 0.84 69,664,400 0.84
Jun 3, 2009 0.44 0.49 0.43 0.47 9,815,600 0.47
Jun 2, 2009 0.45 0.47 0.43 0.43 5,575,500 0.43
Jun 1, 2009 0.38 0.47 0.38 0.43 11,567,500 0.43
May 29, 2009 0.39 0.41 0.37 0.37 6,226,000 0.37
May 28, 2009 0.37 0.42 0.35 0.38 11,554,900 0.38
Generex will continue to monitor and execute the ongoing Generex Oral-lyn(TM) study according to protocol and national/international ICH-GCPs. The study's endpoint is for Generex Oral-lyn(TM) to achieve non-inferiority to injectable meal-time (prandial) insulin. Formal verification of the non-inferiority hypothesis should be achieved by the statistical power set out in the protocol. Following the execution of the study's first interim analysis in approximately two months, the enrollment of additional subjects in the study may possibly be terminated. This in turn would establish an approximate end-of-study-treatment-period in December 2010.
To date, no Generex Oral-lyn(TM) drug-related "Serious Adverse Events" (SAEs) have been reported, which also supports the current initiatives of the study.
2 meses depois......

olhem para aquilo que aconteceu no dia 5 de junho de 2009 à cotação da generex, quando esta divulgou os resultados do oral lyn, conhecidos à data.
Jun 5, 2009 0.85 1.14 0.72 0.81 75,070,400 0.81
Jun 4, 2009 0.50 0.87 0.49 0.84 69,664,400 0.84
Jun 3, 2009 0.44 0.49 0.43 0.47 9,815,600 0.47
Jun 2, 2009 0.45 0.47 0.43 0.43 5,575,500 0.43
Jun 1, 2009 0.38 0.47 0.38 0.43 11,567,500 0.43
May 29, 2009 0.39 0.41 0.37 0.37 6,226,000 0.37
May 28, 2009 0.37 0.42 0.35 0.38 11,554,900 0.38
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pedro200 Escreveu:according to :
asco 2010 ABSTRACT....
we know that using AE37 in BC patients would give recurrence rate of 2.9% (2 out of 67) and without using AE37 recurrence rate is 7.2% (6 out 83)
the questions that we ask ourselves are:
1- What can we learn from these numbers?
2- What should we expect to get from PIII
3- Does AE37 work?
The Answers are:
1- We can learn alot from the above:
when we use a group of 67 patients and we
estimate the probability of recurrence which is 0.029, we know from the probbaility and statistic theory (see fro example Probability & statistic by A. Papoulis p.283) that the standard diviation of this kind of estimation is d=sqrt(p*(1-p)/N) where , and we also know that using the +/- sigma theory we can expect that for future trials 68% of the results would give p-d=0.029 or p+d=0.029
solving the above would give the following:
p=1/67 -- 4/67 or 1.5% to 5.9%
this means that on the worse case we would have 5.9% recurence this is still better than 7.2% by about 18.1%, however we can also get the best result which is 1.5% which is 79.2% better comapred to non AE37 case, BUT we should expect to get sometyhing in the middle which is recurrence=3.7% (1.5+5.9)/2 which is about 48.6% better to non AE37.
when we have compared to the non AE37 case we used recurrence as we saw on the Generex ASCO
abstract which was 7.2%. this number could be verified with the surce : http://www.gaeainitiative.eu/word_page/B... which indicates that recurrence after about 13-14mo is about 7.2%.
2. base on the above we can say that we should expect a 3.7% recurrence using AE37 compared to 7.2% without using the AE37 which is abot 48% better
3. Using the results so far and the probability & statistic theory (Papoulis p. 283) we have concluded that on the worse case the recurrence would be 5.9% and the best would be 1.5% but both are unlikley so we can expect with high probability to get something in the middle which is 3.7% so the answer YES AE37 WORKS!!!!!
==> 48.6% better to non AE37
só para recordar!!!!
Cumprimentos
(Londres, Inglaterra)
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nk667 Escreveu:Esta patente vai valer muitos B$e eu vou ter muita paciencia e muito tempo para esperar por isso!
Ainda falta anunciarem a partnership...
Bons negocios
antes disso a generex deve divulgar os resulttados da fase II do breast cancer. Desta forma, caso os resultados sejam positivos, a generex consegue subir a parada.....
ainda estou à espera dos resultados da reunião do dia 10 de Junho.....

e os resultados da fase III do oral lyn?
- Mensagens: 577
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