gnbt - momento da verdade
Shevet Escreveu:Boas Pedro, eu pessoalmente, acredito mais num reverse split, não esquecer que até 5 de maio a cotação tem de estar acima de 1usd pelo menos por 10 dias consecutivos, ou seja, têm até dia 20/21 de Abril para a colocarem acima de 1usd e manter pelo menos ate 5 de Maio...............
Não me parece!!!!
Sair do Nasdaq tb não me parece boa ideia, a empresa perderia visibilidade e regulamentação o que poderia repelir os investidores..
Só nos resta mesmo o Reverse...........ou a puxada!!
Abraço
Shevet
ou o Nasdaq permitir mais uma extensão de 180 dias! salvo erro a terceira! não sei se é possível! não estou muito por dentro das regras do nasdaq.
3 hipoteses: puxada
, reverse split 
ou extensão do nasdaq?
abraço
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Boas Pedro, eu pessoalmente, acredito mais num reverse split, não esquecer que até 5 de maio a cotação tem de estar acima de 1usd pelo menos por 10 dias consecutivos, ou seja, têm até dia 20/21 de Abril para a colocarem acima de 1usd e manter pelo menos ate 5 de Maio...............
Não me parece!!!!
Sair do Nasdaq tb não me parece boa ideia, a empresa perderia visibilidade e regulamentação o que poderia repelir os investidores..
Só nos resta mesmo o Reverse...........ou a puxada!!
Abraço
Shevet
Não me parece!!!!
Sair do Nasdaq tb não me parece boa ideia, a empresa perderia visibilidade e regulamentação o que poderia repelir os investidores..
Só nos resta mesmo o Reverse...........ou a puxada!!
Abraço
Shevet
Estás a sentir????
O 50 Cent, looooooool
O 50 Cent, looooooool
-
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- Localização: Caldeirada de Enguias
problema
a gnbt tem até ao dia 5 de Maio para atingir o 1 dolár:
http://biz.yahoo.com/e/091110/gnbt8-k.html
opções:
- reverse split
- divulga noticías bombásticas para conseguir atingir o 1 dolar
ou pura e simplesmente sae do nasdaq!
Bons trades!!!
como já deu para perceber, é de esperar tempos de volatibilidade extrema!!! sofre, sofre, coração...
http://biz.yahoo.com/e/091110/gnbt8-k.html
opções:
- reverse split
- divulga noticías bombásticas para conseguir atingir o 1 dolar
ou pura e simplesmente sae do nasdaq!
Bons trades!!!
como já deu para perceber, é de esperar tempos de volatibilidade extrema!!! sofre, sofre, coração...
- Mensagens: 577
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- Mensagens: 577
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até os enfermeiros já estão a ser treinados para explicar como funciona o oral spray...
http://finance.yahoo.com/news/Generex-A ... l?x=0&.v=1
informação:estou longo na gnbt, cris e ctic
http://finance.yahoo.com/news/Generex-A ... l?x=0&.v=1
informação:estou longo na gnbt, cris e ctic
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Re: informação
Ditrectamente do site da FDA:
http://www.fda.gov/ForConsumers/ByAudie ... 123872.htm
........
treatment IND if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population
........
http://www.fda.gov/ForConsumers/ByAudie ... 123872.htm
........
treatment IND if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population
........
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- Mensagens: 577
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http://www.wtvq.com/health/2880-insulin-spray-
Insulin Spray
Written by Kristi Runyon
Monday, 29 March 2010 12:17
Nearly 1/3 of people with diabetes use insulin and some people with type 2 diabetes eventually need insulin shots to control glucose levels. Researchers are testing an oral spray form of insulin to take away some of the pain of injections.
Diabetes
Normally, when we eat, cells in the pancreas release insulin, a hormone that enables glucose in the blood to enter cells and be used as a source of fuel. Diabetes is a disease that affects the body’s ability to use glucose. There are two main types. In type 1, the pancreas doesn’t produce insulin because of an immune system attack on the insulin-producing cells. In type 2 diabetes the pancreas either doesn’t make a sufficient amount of insulin or the body is no longer able to effectively use the hormone to get fuel into the cells.
According to the American Diabetes Association, about 23.6 million Americans have diabetes. Roughly 1.6 million new cases are diagnosed annually. Type 2 is the most common form of the disease, accounting for 90 to 95 percent of all cases.
Over time, excess glucose in the blood can damage blood vessels and organs. People with diabetes are at high risk for a number of complications, like heart disease, stroke, kidney disease, nerve damage, infections that don’t heal and amputation. The CDC estimates, in 2007, the economic cost of diabetes was $174 billion.
Insulin for Diabetes
There is no cure for diabetes. People with type 1 diabetes don’t make insulin and need regular injections of the hormone to stay alive. Patients with type 2 can often control the disease through diet, exercise, lifestyle modifications and medications. However, some of those with type 2 will eventually need insulin treatment to control glucose levels. The CDC estimates that nearly 1/3 of people with diabetes use insulin.
There are several different forms of insulin. Regular-acting insulin enters the bloodstream within 30 minutes and is effective for about 3 to 6 hours. Rapid-acting insulin gets into the blood very quickly, typically in about 5 minutes and is good for about 2 to 4 hours. Intermediate-acting insulin enters the bloodstream in 2 to 4 hours and is effective for 12 to 18 hours. Long-acting insulin takes about 6 to 10 hours to get into the bloodstream and lasts the longest, usually 20 to 24 hours.
Insulin Spray
Insulin can’t be given in a pill form because the digestive tract breaks it down before it can enter the bloodstream. Therefore, people who need insulin must take regular injections of the hormone. Some people have a hard time accepting the injections, leading to poor compliance and a greater risk for complications from diabetes.
Researchers are now testing a new way to deliver insulin, by using a mouth spray. The new form of insulin is called Oral-lyn™ and it’s delivered through a RapidMist™ device. The RapidMist is similar to an inhaler. But instead of breathing the drug into the lungs, patients hold it inside their mouth, where it is absorbed through the cheek lining. Dennis Gage, M.D., Endocrinologist with Beth Israel Medical Center in New York City, says this lining has a lot of blood vessels, enabling the drug to be quickly absorbed into the bloodstream.
Usage is simple. Gage explains the patient exhales, sprays and holds the drug inside the mouth for about three seconds. A single spray delivers one unit of insulin to the cheek lining. The dosage of insulin can be adjusted by increasing the number of sprays. Thus, if the patient uses more insulin, he/she simply repeats the process until the required dose is achieved.
Oral-lyn™ is a fast-acting type of insulin that’s currently being tested for use before meals. Gage expects that many patients will find the oral spray form of insulin easier and more acceptable to use than injectable forms. However, some people, especially those with type 1 diabetes, will still need injections of longer-acting insulin to control their glucose levels.
There are two clinical trials currently being conducted for Oral-lyn™. For information on the Phase III trial for patients with type I diabetes, go to http://www.clinicaltrials.gov. Then type in the trial identification number: NCT00668850. Information on the trial for patients with type 1 and type 2 diabetes can be found on the same site using the trial identification number, NCT00948493.
AUDIENCE INQUIRY
There are two clinical trials currently being conducted for Oral-lyn™. For information on the Phase III trial for patients with type I diabetes, go to http://www.clinicaltrials.gov. Then type in the trial identification number: NCT00668850. Information on the trial for patients with type 1 and type 2 diabetes can be found on the same site using the trial identification number, NCT00948493.
For information on Oral-lyn™, go to the company’s website at http://www.generex.com
For general information on diabetes or insulin treatment:
American Diabetes Association, http://www.diabetes.org
Centers for Disease Control and Prevention, http://www.cdc.gov/diabetes
National Institute of Diabetes and Digestive and Kidney Diseases, http://www.niddk.nih.gov
Research compiled and edited by Barbara J. Fister
Insulin Spray
Written by Kristi Runyon
Monday, 29 March 2010 12:17
Nearly 1/3 of people with diabetes use insulin and some people with type 2 diabetes eventually need insulin shots to control glucose levels. Researchers are testing an oral spray form of insulin to take away some of the pain of injections.
Diabetes
Normally, when we eat, cells in the pancreas release insulin, a hormone that enables glucose in the blood to enter cells and be used as a source of fuel. Diabetes is a disease that affects the body’s ability to use glucose. There are two main types. In type 1, the pancreas doesn’t produce insulin because of an immune system attack on the insulin-producing cells. In type 2 diabetes the pancreas either doesn’t make a sufficient amount of insulin or the body is no longer able to effectively use the hormone to get fuel into the cells.
According to the American Diabetes Association, about 23.6 million Americans have diabetes. Roughly 1.6 million new cases are diagnosed annually. Type 2 is the most common form of the disease, accounting for 90 to 95 percent of all cases.
Over time, excess glucose in the blood can damage blood vessels and organs. People with diabetes are at high risk for a number of complications, like heart disease, stroke, kidney disease, nerve damage, infections that don’t heal and amputation. The CDC estimates, in 2007, the economic cost of diabetes was $174 billion.
Insulin for Diabetes
There is no cure for diabetes. People with type 1 diabetes don’t make insulin and need regular injections of the hormone to stay alive. Patients with type 2 can often control the disease through diet, exercise, lifestyle modifications and medications. However, some of those with type 2 will eventually need insulin treatment to control glucose levels. The CDC estimates that nearly 1/3 of people with diabetes use insulin.
There are several different forms of insulin. Regular-acting insulin enters the bloodstream within 30 minutes and is effective for about 3 to 6 hours. Rapid-acting insulin gets into the blood very quickly, typically in about 5 minutes and is good for about 2 to 4 hours. Intermediate-acting insulin enters the bloodstream in 2 to 4 hours and is effective for 12 to 18 hours. Long-acting insulin takes about 6 to 10 hours to get into the bloodstream and lasts the longest, usually 20 to 24 hours.
Insulin Spray
Insulin can’t be given in a pill form because the digestive tract breaks it down before it can enter the bloodstream. Therefore, people who need insulin must take regular injections of the hormone. Some people have a hard time accepting the injections, leading to poor compliance and a greater risk for complications from diabetes.
Researchers are now testing a new way to deliver insulin, by using a mouth spray. The new form of insulin is called Oral-lyn™ and it’s delivered through a RapidMist™ device. The RapidMist is similar to an inhaler. But instead of breathing the drug into the lungs, patients hold it inside their mouth, where it is absorbed through the cheek lining. Dennis Gage, M.D., Endocrinologist with Beth Israel Medical Center in New York City, says this lining has a lot of blood vessels, enabling the drug to be quickly absorbed into the bloodstream.
Usage is simple. Gage explains the patient exhales, sprays and holds the drug inside the mouth for about three seconds. A single spray delivers one unit of insulin to the cheek lining. The dosage of insulin can be adjusted by increasing the number of sprays. Thus, if the patient uses more insulin, he/she simply repeats the process until the required dose is achieved.
Oral-lyn™ is a fast-acting type of insulin that’s currently being tested for use before meals. Gage expects that many patients will find the oral spray form of insulin easier and more acceptable to use than injectable forms. However, some people, especially those with type 1 diabetes, will still need injections of longer-acting insulin to control their glucose levels.
There are two clinical trials currently being conducted for Oral-lyn™. For information on the Phase III trial for patients with type I diabetes, go to http://www.clinicaltrials.gov. Then type in the trial identification number: NCT00668850. Information on the trial for patients with type 1 and type 2 diabetes can be found on the same site using the trial identification number, NCT00948493.
AUDIENCE INQUIRY
There are two clinical trials currently being conducted for Oral-lyn™. For information on the Phase III trial for patients with type I diabetes, go to http://www.clinicaltrials.gov. Then type in the trial identification number: NCT00668850. Information on the trial for patients with type 1 and type 2 diabetes can be found on the same site using the trial identification number, NCT00948493.
For information on Oral-lyn™, go to the company’s website at http://www.generex.com
For general information on diabetes or insulin treatment:
American Diabetes Association, http://www.diabetes.org
Centers for Disease Control and Prevention, http://www.cdc.gov/diabetes
National Institute of Diabetes and Digestive and Kidney Diseases, http://www.niddk.nih.gov
Research compiled and edited by Barbara J. Fister
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eles estão dentro:
http://www.mentorcapital.com/Cancer_Imm ... _Index.pdf
as coisas não estão a correr bem, mas uma coisa é certa, se estão dentro é porque acreditam no potencial da generex!!! penso eu....
http://www.mentorcapital.com/Cancer_Imm ... _Index.pdf
as coisas não estão a correr bem, mas uma coisa é certa, se estão dentro é porque acreditam no potencial da generex!!! penso eu....
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April 06, 2010
Generex Launches $250,000,000 Lawsuit Against TheStreet.com and Feuerstein
esta notícia é recente!
http://www.generex.com/press_release_desc.php?id=167
esta notícia saiu cerca de uma hora depois do Feuerstein divulgar mais um artigo (o 3º) a falar mal da generex (saiu por volta das 15h30 da tarde).
isto revela bom sentido de oportunidade do management da gnbt para defender a cotação....
esta notícia é recente!
http://www.generex.com/press_release_desc.php?id=167
esta notícia saiu cerca de uma hora depois do Feuerstein divulgar mais um artigo (o 3º) a falar mal da generex (saiu por volta das 15h30 da tarde).
isto revela bom sentido de oportunidade do management da gnbt para defender a cotação....
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informação
Generex announced in late 2009 that the U.S. FDA has granted approval for the treatment use of Generex Oral-lyn under the FDA's Treatment Investigational New Drug (IND) program. The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing.
esta notícia já é antiga!
mas o interessante nela é que em 39 produtos que mereceram da FDA esta distinção, todos conseguiram mais tarde aprovação por parte da FDA! 39 em 39!
se o oral spray entrar no mercado, será 40 em 40!
esta notícia já é antiga!
mas o interessante nela é que em 39 produtos que mereceram da FDA esta distinção, todos conseguiram mais tarde aprovação por parte da FDA! 39 em 39!
se o oral spray entrar no mercado, será 40 em 40!
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video
Gerald Bernstein, Former President of the American Diabetes Association and now Generex’s VP of Medical Affairs, discusses oral delivery of insulin via Oral-Lyn.
Interessante:
http://www.thedoctorschannel.com/video/ ... specialty=
se a FDA aprovar este spray... vai ser bonito!
Interessante:
http://www.thedoctorschannel.com/video/ ... specialty=
se a FDA aprovar este spray... vai ser bonito!
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mais uma possível noticia!
brevemente deve estar para sair uma notícia relacionada com as vendas do Crave-NX(TM)7-Day Diet Aid Spray em New York! (nos últimos 3 meses)
ver link:
http://finance.yahoo.com/news/New-York- ... l?x=0&.v=1
ver link:
http://finance.yahoo.com/news/New-York- ... l?x=0&.v=1
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http://seekingalpha.com/article/198633- ... urce=yahoo
Generex's Antigen Express: Creating the Next Generation of Cancer Immunotherapy
Antigen Express is the fully owned life science subsidiary of Generex Biotechnology (GNBT). Antigen Express is building an impressive pipeline of next generation synthetic therapeutics aimed at a variety of major diseases, including cancer and infectious diseases. The platform technology of Antigen Express allows for antigen-specific stimulation of a T-helper response to virtually any antigen of known pathogenic potential. Antigen Express is currently evaluating its leading candidate, the novel Ii-key hybrid HER2/neu peptide AE37 vaccine, in a multi-center Phase II trial for patients with breast cancer under a research agreement with the United States Military Cancer Institute.
AE37 is an immunotherapeutic synthetic peptide vaccine designed to prevent the recurrence of a variety of different cancers that express the HER-2/neu peptide. An advantage of Antigen Express' immunotherapy is that it causes none of the toxicities typically associated with classical chemotherapy. While the target of AE37 is the same as that of the Roche's (RHHBY.PK) blockbuster cancer drug Herceptin, the activity of AE37 relies on its ability to stimulate a patient's own immune system to recognize the cancer target rather than by interacting with the target directly.
New AE37 Data to be Presented at ASCO 2010
I found evidence that new data for the AE37 vaccine will be presented at the 2010 American Society of Clinical Oncology Annual Meeting to be held in Chicago from June 4-8, 2010. ASCO 2010 abstracts will be available on the company's Annual Meeting website in mid-May, although abstract titles can currently be found on the event itinerary page. The title of an AE37 abstract being presented at ASCO 2010 is Effect of a Novel Ii-key Hybrid HER2/neu Peptide AE37 Vaccine with GM-CSF as Compared to GM-CSF Alone on Levels of Regulatory T-cell Treg Populations. The listed author/speaker is Dr. Guy T Clifton, who has worked extensively on peptide based therapeutic vaccines at the USMCI with Antigen Express collaborator Col. George Peoples.
If Dr. Clifton highlights Phase II data that confirms previously reported Phase I data regarding AE37's effect on regulatory T-cell Tregs, that would be great news for Antigen Express. The Phase I trial for AE37 in breast cancer patients showed that Tregs were reduced in all patients tested pre- to post-vaccination. This smaller Phase I trial also found that DTH responses increased in all patients from pre- to post-vaccination p<0.0001. Boding well in this trial for the vaccine was that there was an inverse relationship between the degree of Treg reduction and the size of DTH response to AE37. The researchers concluded in this trial that the reduced levels of Tregs in vaccinated patients appear to be associated with more robust responses in ex vivo immune assays and in vivo DTH reactions suggesting that the AE37 vaccine may be clinically useful.
This pending update follows the impressive interim results for the AE37 vaccine in its current Phase II trial which were unveiled at the San Antonio Breast Cancer Symposium in December 2009. Two hundred disease-free, high risk, breast cancer patients who had completed standard adjuvant therapy are being enrolled and randomized to receive six monthly inoculations of either the AE37 peptide vaccine or the adjuvant GM-CSF alone to compare their ability to prevent cancer recurrence. This interim analysis followed the first 49 patients in the AE37 group and the first 71 for the control group. At a median follow up of 13 months, there were no (0.0%) recurrences in the AE37 group of patients, 0/49, compared to 7.0%, 5/71, in the control group. You can view the SABCS poster from December here.
AE37 Phase I Results for Prostate Cancer Patients to be Presented at the 25th Annual EAU Congress
This same AE37 peptide vaccine has been evaluated in a Phase I trial with prostate cancer patients. The Phase I results for patients with prostate cancer were first announced at the 2009 ASCO Annual meeting and will be presented at next week's 25th Annual EAU Congress in Barcelona. I found the information online, which is open to public viewing. The studies were conducted at St. Savas Hospital in Athens, Greece. Dr T.K. Karaolides from Saint Savas Cancer Hospital is listed as the speaker at to present these findings during the session "Focal and Systemic Therapies".
The results of study with prostate cancer patients have so far been consistent with those of prior clinical trials of AE37 in patients with breast cancer. Results have shown the AE37 HER2/neu hybrid peptide vaccine has very limited toxicity, with no patients experiencing toxicity over Grade 2. That is a very important advantage since most cancer drugs are hard to tolerate. This listing for the 25th Annual EAU Congress in Barcelona suggests we will soon hear an update for the vaccine with prostate cancer patients.
AE37's Market Potential
Roche and Genentech's (DNA) blockbuster drug, Herceptin, which also zeroes in on cancer that is over-expressing HER-2/neu, can be used only in patients expressing the highest level of HER-2, or about 25 percent of breast cancer patients. In comparison, the AE37 peptide vaccine stimulates the immune system to recognize tumor cells in patients with a lower expression of HER-2, so that 75 percent of breast cancer patients would respond to Antigen's vaccine. Herceptin sales in 2008 were $1.8 billion, and reached approximately $2.5 billion in the first half of 2009.
The potential market for Antigen's vaccine could be even larger since it can be used in more HER-2 patients, and when considering the licensing potential of using AE37 in combination with treatments from other firms. Antigen Express has stated it believes there could be a synergistic response if they use Herceptin with an immunological drug like AE37, but currently the company is more focused on looking at AE37 alone or in combination with other peptides (such as in the AE37 Combo Vaccine).
AE37 Combo Vaccine for Breast and Ovarian Cancer Patients
Beyond the trials previously mentioned, Antigen Express announced in May 2009 that the first patient has received the immunotherapeutic AE37 vaccine as part of a new combination therapy approach for breast and ovarian cancer patients. This vaccine therapy is designed to activate immune cells that can detect and destroy cancer cells. The new Phase I clinical trial is being performed at and fully funded by the Mary Crowley Cancer Research Center in Dallas. It will assess safety and immunological response in patients with either breast and/ or ovarian cancer.
In this new trial, AE37 will be paired with a second HER-2/neu-derived peptide, GP2, designed to stimulate a different portion of the immune system. AE37 stimulates the CD4 cells, considered the immunological generals, while the other peptide stimulates the CD8 cells, which act as the infantry in this unified war against cancer. Enrollment was targeted to be completed this year.
Developed to Prevent Cancer Recurrence
Generex currently has a market cap of just under $120 million, and I believe its wholly owned subsidiary is overlooked and not properly valued alongside other life science developmental firms. If AE37 continues to stimulate such impressive results, then I feel Antigen Express will move towards the top of the list among the companies that are developing therapeutic cancer vaccines. While no cancer vaccine is currently approved by the FDA, most investors are aware that Dendreon Corporation (DNDN) has a May 1st PDUFA date for Provenge which is designed to treat metastatic prostate cancer.
Since AE37 is being developed to prevent cancer recurrence, I hope Antigen Express' offering will eventually make another drug or vaccine such as Provenge, designed to treat metastatic cancer, one that stays in the back room of the pharmacy. AE37 may lead to longer and healthier lives, while Dendreon's significant advance may extend the last stage of life by a few precious months. They both may prove to be great medical advances to usher in a new era of immunotherapeutic vaccines to revolutionize how cancer is treated.
Small Firm Attempts to Fund a Potential Blockbuster Pipeline
Antigen Express' parent company, Generex Biotechnology, announced last week that it has reached a funding commitment from a private investment partnership, Seaside88, where they will purchase up to 49,455,130 shares of Generex common stock in 25 bi-weekly tranches. More specific terms of this deal can be found on Generex investor relations page under its press releases and SEC filings. As of the latest quarterly filing, Generex recorded 23.6 million in cash and it has been managing a frugal quarterly burn rate of 3 to 4 million, although that figure may increase due to funding requirements of its planned activities. Generex's funding needs may increase for its worldwide Phase III trial, for its novel buccal insulin spray, Oral-lyn, as well as to support the Treatment IND awarded by the FDA for this non-invasive insulin delivery system. With approximately 253 million shares currently outstanding, this figure should increase to over 300 million if the agreement with Seaside88 reaches full commitment.
Moving Forward to Reach its Goals
While Generex has stated that it has begun active discussions with pharmaceutical companies for potential joint ventures and licensing agreements for AE37, it has also visibly strengthened its own financial position. I believe this will enable the company to move forward in realizing its clinical goals, as these discussions may be time consuming and uncertain. As a result of the continued successful study results for AE37, Generex has stated that a Phase III study for breast cancer patients is being planned for later in 2010, as well as a Phase II study for prostate cancer patients. While many hurdles remain before it, I believe Antigen Express will earn a place on the front line in the war against cancer and the company should be noted for its significant market potential.
Generex's Antigen Express: Creating the Next Generation of Cancer Immunotherapy
Antigen Express is the fully owned life science subsidiary of Generex Biotechnology (GNBT). Antigen Express is building an impressive pipeline of next generation synthetic therapeutics aimed at a variety of major diseases, including cancer and infectious diseases. The platform technology of Antigen Express allows for antigen-specific stimulation of a T-helper response to virtually any antigen of known pathogenic potential. Antigen Express is currently evaluating its leading candidate, the novel Ii-key hybrid HER2/neu peptide AE37 vaccine, in a multi-center Phase II trial for patients with breast cancer under a research agreement with the United States Military Cancer Institute.
AE37 is an immunotherapeutic synthetic peptide vaccine designed to prevent the recurrence of a variety of different cancers that express the HER-2/neu peptide. An advantage of Antigen Express' immunotherapy is that it causes none of the toxicities typically associated with classical chemotherapy. While the target of AE37 is the same as that of the Roche's (RHHBY.PK) blockbuster cancer drug Herceptin, the activity of AE37 relies on its ability to stimulate a patient's own immune system to recognize the cancer target rather than by interacting with the target directly.
New AE37 Data to be Presented at ASCO 2010
I found evidence that new data for the AE37 vaccine will be presented at the 2010 American Society of Clinical Oncology Annual Meeting to be held in Chicago from June 4-8, 2010. ASCO 2010 abstracts will be available on the company's Annual Meeting website in mid-May, although abstract titles can currently be found on the event itinerary page. The title of an AE37 abstract being presented at ASCO 2010 is Effect of a Novel Ii-key Hybrid HER2/neu Peptide AE37 Vaccine with GM-CSF as Compared to GM-CSF Alone on Levels of Regulatory T-cell Treg Populations. The listed author/speaker is Dr. Guy T Clifton, who has worked extensively on peptide based therapeutic vaccines at the USMCI with Antigen Express collaborator Col. George Peoples.
If Dr. Clifton highlights Phase II data that confirms previously reported Phase I data regarding AE37's effect on regulatory T-cell Tregs, that would be great news for Antigen Express. The Phase I trial for AE37 in breast cancer patients showed that Tregs were reduced in all patients tested pre- to post-vaccination. This smaller Phase I trial also found that DTH responses increased in all patients from pre- to post-vaccination p<0.0001. Boding well in this trial for the vaccine was that there was an inverse relationship between the degree of Treg reduction and the size of DTH response to AE37. The researchers concluded in this trial that the reduced levels of Tregs in vaccinated patients appear to be associated with more robust responses in ex vivo immune assays and in vivo DTH reactions suggesting that the AE37 vaccine may be clinically useful.
This pending update follows the impressive interim results for the AE37 vaccine in its current Phase II trial which were unveiled at the San Antonio Breast Cancer Symposium in December 2009. Two hundred disease-free, high risk, breast cancer patients who had completed standard adjuvant therapy are being enrolled and randomized to receive six monthly inoculations of either the AE37 peptide vaccine or the adjuvant GM-CSF alone to compare their ability to prevent cancer recurrence. This interim analysis followed the first 49 patients in the AE37 group and the first 71 for the control group. At a median follow up of 13 months, there were no (0.0%) recurrences in the AE37 group of patients, 0/49, compared to 7.0%, 5/71, in the control group. You can view the SABCS poster from December here.
AE37 Phase I Results for Prostate Cancer Patients to be Presented at the 25th Annual EAU Congress
This same AE37 peptide vaccine has been evaluated in a Phase I trial with prostate cancer patients. The Phase I results for patients with prostate cancer were first announced at the 2009 ASCO Annual meeting and will be presented at next week's 25th Annual EAU Congress in Barcelona. I found the information online, which is open to public viewing. The studies were conducted at St. Savas Hospital in Athens, Greece. Dr T.K. Karaolides from Saint Savas Cancer Hospital is listed as the speaker at to present these findings during the session "Focal and Systemic Therapies".
The results of study with prostate cancer patients have so far been consistent with those of prior clinical trials of AE37 in patients with breast cancer. Results have shown the AE37 HER2/neu hybrid peptide vaccine has very limited toxicity, with no patients experiencing toxicity over Grade 2. That is a very important advantage since most cancer drugs are hard to tolerate. This listing for the 25th Annual EAU Congress in Barcelona suggests we will soon hear an update for the vaccine with prostate cancer patients.
AE37's Market Potential
Roche and Genentech's (DNA) blockbuster drug, Herceptin, which also zeroes in on cancer that is over-expressing HER-2/neu, can be used only in patients expressing the highest level of HER-2, or about 25 percent of breast cancer patients. In comparison, the AE37 peptide vaccine stimulates the immune system to recognize tumor cells in patients with a lower expression of HER-2, so that 75 percent of breast cancer patients would respond to Antigen's vaccine. Herceptin sales in 2008 were $1.8 billion, and reached approximately $2.5 billion in the first half of 2009.
The potential market for Antigen's vaccine could be even larger since it can be used in more HER-2 patients, and when considering the licensing potential of using AE37 in combination with treatments from other firms. Antigen Express has stated it believes there could be a synergistic response if they use Herceptin with an immunological drug like AE37, but currently the company is more focused on looking at AE37 alone or in combination with other peptides (such as in the AE37 Combo Vaccine).
AE37 Combo Vaccine for Breast and Ovarian Cancer Patients
Beyond the trials previously mentioned, Antigen Express announced in May 2009 that the first patient has received the immunotherapeutic AE37 vaccine as part of a new combination therapy approach for breast and ovarian cancer patients. This vaccine therapy is designed to activate immune cells that can detect and destroy cancer cells. The new Phase I clinical trial is being performed at and fully funded by the Mary Crowley Cancer Research Center in Dallas. It will assess safety and immunological response in patients with either breast and/ or ovarian cancer.
In this new trial, AE37 will be paired with a second HER-2/neu-derived peptide, GP2, designed to stimulate a different portion of the immune system. AE37 stimulates the CD4 cells, considered the immunological generals, while the other peptide stimulates the CD8 cells, which act as the infantry in this unified war against cancer. Enrollment was targeted to be completed this year.
Developed to Prevent Cancer Recurrence
Generex currently has a market cap of just under $120 million, and I believe its wholly owned subsidiary is overlooked and not properly valued alongside other life science developmental firms. If AE37 continues to stimulate such impressive results, then I feel Antigen Express will move towards the top of the list among the companies that are developing therapeutic cancer vaccines. While no cancer vaccine is currently approved by the FDA, most investors are aware that Dendreon Corporation (DNDN) has a May 1st PDUFA date for Provenge which is designed to treat metastatic prostate cancer.
Since AE37 is being developed to prevent cancer recurrence, I hope Antigen Express' offering will eventually make another drug or vaccine such as Provenge, designed to treat metastatic cancer, one that stays in the back room of the pharmacy. AE37 may lead to longer and healthier lives, while Dendreon's significant advance may extend the last stage of life by a few precious months. They both may prove to be great medical advances to usher in a new era of immunotherapeutic vaccines to revolutionize how cancer is treated.
Small Firm Attempts to Fund a Potential Blockbuster Pipeline
Antigen Express' parent company, Generex Biotechnology, announced last week that it has reached a funding commitment from a private investment partnership, Seaside88, where they will purchase up to 49,455,130 shares of Generex common stock in 25 bi-weekly tranches. More specific terms of this deal can be found on Generex investor relations page under its press releases and SEC filings. As of the latest quarterly filing, Generex recorded 23.6 million in cash and it has been managing a frugal quarterly burn rate of 3 to 4 million, although that figure may increase due to funding requirements of its planned activities. Generex's funding needs may increase for its worldwide Phase III trial, for its novel buccal insulin spray, Oral-lyn, as well as to support the Treatment IND awarded by the FDA for this non-invasive insulin delivery system. With approximately 253 million shares currently outstanding, this figure should increase to over 300 million if the agreement with Seaside88 reaches full commitment.
Moving Forward to Reach its Goals
While Generex has stated that it has begun active discussions with pharmaceutical companies for potential joint ventures and licensing agreements for AE37, it has also visibly strengthened its own financial position. I believe this will enable the company to move forward in realizing its clinical goals, as these discussions may be time consuming and uncertain. As a result of the continued successful study results for AE37, Generex has stated that a Phase III study for breast cancer patients is being planned for later in 2010, as well as a Phase II study for prostate cancer patients. While many hurdles remain before it, I believe Antigen Express will earn a place on the front line in the war against cancer and the company should be noted for its significant market potential.
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olhem para o volume nos ulimos 10 dias!!! muito estranho... digo eu! se calhar estou a ver fantasmas...
a street.com disse quue a abk era um dead stock e uma semana depois...a cotação subiu desde os 0,5 até aos 3,30!
a street.com disse que a gnbt era lixo e pouco tempo depois.... será?
a street.com disse quue a abk era um dead stock e uma semana depois...a cotação subiu desde os 0,5 até aos 3,30!
a street.com disse que a gnbt era lixo e pouco tempo depois.... será?
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
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