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Tuesday April 11, 6:01 am Eastern Time
Company Press Release
FDA and MCA Allow Aphton`s Applications for
Pancreatic Cancer Pivotal Phase III Trials
MIAMI--(BW HealthWire)--April 11, 2000--Aphton Corporation (NASDAQ NMS:
APHT - news). The FDA has allowed Aphton`s application to commence a pivotal Phase
III clinical trial for the treatment of metastatic pancreatic cancer, with a combination immuno-chemo therapy regimen of
Aphton`s anti-G17 immunogen and gemcitabine (Gemzar) versus gemcitabine. Gemcitabine, a chemotherapeutic, is the current
standard of care for treatment of pancreatic cancer in the US. In clinical trials, it has been shown to increase median survival by
five weeks, from approximately 4.4 to 5.65 months.
The primary center for this randomized, double blind trial will be the University of California Los Angeles (UCLA) School of
Medicine Cancer Center. This trial will be harmonized with the European trial below and initiated immediately thereafter.
A second pivotal Phase III trial has been allowed, by the Medicines Control Agency (MCA) in the UK, for the treatment of
advanced pancreatic cancer. Aphton`s anti-G17 immunogen will be tested directly against gemcitabine. Gemcitabine has not
been adopted as the standard of care in every country in Europe for the treatment of pancreatic cancer. While the primary
center for this randomized, double blind trial will be in the UK, it will be expanded to continental Europe following
commencement in the UK.
Aphton`s anti-gastrin therapy represents a unique and innovative biological treatment for patients suffering from gastrointestinal
system cancers. Aphton`s anti-gastrin drug induces a directed antibody response against gastrin and other gastrin-related
growth factors. Gastrin has been established as a central hormonal growth factor that stimulates gastrointestinal cancer cells to
proliferate and spread.
It is estimated that approximately 88,000 new cases of pancreatic cancer will be diagnosed in the US and Europe this year.
The prognosis for most of these patients is very poor. The great majority of patients has advanced disease at the time of
diagnosis and is considered incurable, with a very short median survival time. In the US, patients diagnosed with pancreatic
cancer (all stages) have five-year survival rates of only four percent. Surgery, when possible, and chemotherapy are the primary
treatment options currently available, but have shown only very limited benefit. Aphton believes that its anti-gastrin vaccine
approach has the potential to extend patient survival without adding to toxicity in a therapeutic regimen.
Aphton Corporation is a biopharmaceutical company developing products using its innovative vaccine-like technology for
neutralizing hormones that participate in gastrointestinal system and reproductive system cancer and non-cancer diseases; and
the prevention of pregnancy. Aphton has strategic alliances with Aventis Pasteur (formerly Pasteur Merieux Connaught,
Rhone-Poulenc Group), SmithKline Beecham PLC, Schering Plough Animal Health and the World Health Organization
(WHO).
Except for the historical information herein, the matters discussed herein include forward-looking statements that may involve a
number of risks and uncertainties. Future results may vary significantly based on a number of factors including, but not limited
to, intellectual property risks, risks in regulatory and market acceptance of new products and continuing demand for same, the
impact of competitive products and pricing, changing economic conditions and other risk factors detailed in Aphton`s most
recent 10-K and other filings with the Securities and Exchange Commission.
Company Press Release
FDA and MCA Allow Aphton`s Applications for
Pancreatic Cancer Pivotal Phase III Trials
MIAMI--(BW HealthWire)--April 11, 2000--Aphton Corporation (NASDAQ NMS:
APHT - news). The FDA has allowed Aphton`s application to commence a pivotal Phase
III clinical trial for the treatment of metastatic pancreatic cancer, with a combination immuno-chemo therapy regimen of
Aphton`s anti-G17 immunogen and gemcitabine (Gemzar) versus gemcitabine. Gemcitabine, a chemotherapeutic, is the current
standard of care for treatment of pancreatic cancer in the US. In clinical trials, it has been shown to increase median survival by
five weeks, from approximately 4.4 to 5.65 months.
The primary center for this randomized, double blind trial will be the University of California Los Angeles (UCLA) School of
Medicine Cancer Center. This trial will be harmonized with the European trial below and initiated immediately thereafter.
A second pivotal Phase III trial has been allowed, by the Medicines Control Agency (MCA) in the UK, for the treatment of
advanced pancreatic cancer. Aphton`s anti-G17 immunogen will be tested directly against gemcitabine. Gemcitabine has not
been adopted as the standard of care in every country in Europe for the treatment of pancreatic cancer. While the primary
center for this randomized, double blind trial will be in the UK, it will be expanded to continental Europe following
commencement in the UK.
Aphton`s anti-gastrin therapy represents a unique and innovative biological treatment for patients suffering from gastrointestinal
system cancers. Aphton`s anti-gastrin drug induces a directed antibody response against gastrin and other gastrin-related
growth factors. Gastrin has been established as a central hormonal growth factor that stimulates gastrointestinal cancer cells to
proliferate and spread.
It is estimated that approximately 88,000 new cases of pancreatic cancer will be diagnosed in the US and Europe this year.
The prognosis for most of these patients is very poor. The great majority of patients has advanced disease at the time of
diagnosis and is considered incurable, with a very short median survival time. In the US, patients diagnosed with pancreatic
cancer (all stages) have five-year survival rates of only four percent. Surgery, when possible, and chemotherapy are the primary
treatment options currently available, but have shown only very limited benefit. Aphton believes that its anti-gastrin vaccine
approach has the potential to extend patient survival without adding to toxicity in a therapeutic regimen.
Aphton Corporation is a biopharmaceutical company developing products using its innovative vaccine-like technology for
neutralizing hormones that participate in gastrointestinal system and reproductive system cancer and non-cancer diseases; and
the prevention of pregnancy. Aphton has strategic alliances with Aventis Pasteur (formerly Pasteur Merieux Connaught,
Rhone-Poulenc Group), SmithKline Beecham PLC, Schering Plough Animal Health and the World Health Organization
(WHO).
Except for the historical information herein, the matters discussed herein include forward-looking statements that may involve a
number of risks and uncertainties. Future results may vary significantly based on a number of factors including, but not limited
to, intellectual property risks, risks in regulatory and market acceptance of new products and continuing demand for same, the
impact of competitive products and pricing, changing economic conditions and other risk factors detailed in Aphton`s most
recent 10-K and other filings with the Securities and Exchange Commission.
Friday December 8, 6:08 am Eastern Time
Press Release
Aphton to Commence Colorectal Cancer Clinical Trial
in US With Patients Who Have Failed Approved
Chemotherapy
MIAMI--(BW HealthWire)--Dec. 8, 2000--Aphton (Nasdaq:APHT - news), a company with products in pivotal and
late-stage clinical trials for cancer therapy, is commencing a clinical trial with patients who have failed the approved
chemotherapy regimen (5-FU and irinotecan) for the treatment of colorectal cancer, stage Dukes` D. Patients will be treated
with a combination regimen of Aphton`s anti-G17 immunogen and irinotecan. Aphton plans to file for a ``fast track`` marketing
approval when a sufficient number of such ``chemo-refractive`` terminal patients respond to the treatment.
Aphton is now in the process of enlisting clinical trial sites and investigators in the US to participate in this trial, which is being
conducted under an IND in place with the US FDA. Aphton is also evaluating the design and timing of a similar trial in Europe.
Aphton is also currently conducting pivotal and other advanced phase clinical trials in the US and Europe for pancreatic,
colorectal and gastric cancer patients. (See previous Aphton news releases.)
Colorectal cancer is the second most common cause of cancer death in the Western world. Its rate of incidence increases
steeply with age. Presently, in the US alone, there are an estimated 760,000 people with diagnosed colorectal cancer, with
more than 130,000 new cases being diagnosed yearly. Of the 760,000 patient total, over 40% are expected to die within the
next 5 years. A large majority of the approximately 60,000 patients who will die during the year 2000 (as estimated by the
American Cancer Society) will have been treated with chemotherapy that failed when they became unresponsive, a condition
referred to as chemo-refractory. With the prognosis so grim, the need for improved colorectal cancer therapy, particularly for
chemo-refractory patients, is large and urgent.
Aphton`s anti-gastrin therapy represents a unique, non-toxic and innovative biological treatment for patients suffering from
gastrointestinal system cancers. Aphton`s anti-gastrin drug induces a directed antibody response against gastrin and other
gastrin-related growth factors. Gastrin has been established as a central hormonal growth factor that stimulates gastrointestinal
cancer cells to proliferate and spread.
Aphton Corporation is a biopharmaceutical company in late-stage, pivotal Phase III clinical trials. Aphton is developing
products using its innovative vaccine-like technology for neutralizing, and removing from circulation, hormones that participate in
gastrointestinal system and reproductive system diseases, both cancer and non-cancer. Aphton is also developing products for
neutralizing hormones to prevent pregnancy. Aphton has strategic alliances with Aventis Pasteur (NYSE:AVE - news),
SmithKline Beecham PLC (NYSE:SBH - news), Schering Plough Animal Health (NYSE:SGP - news) and the World Health
Organization (WHO).
Except for the historical information herein, the matters discussed herein include forward-looking statements that may involve a
number of risks and uncertainties. Future results may vary significantly based on a number of factors including, but not limited
to, intellectual property risks, risks in regulatory and market acceptance of new products and continuing demand for same, the
impact of competitive products and pricing, changing economic conditions and other risk factors detailed in Aphton`s most
recent 10-K and other filings with the Securities and Exchange Commission.
Press Release
Aphton to Commence Colorectal Cancer Clinical Trial
in US With Patients Who Have Failed Approved
Chemotherapy
MIAMI--(BW HealthWire)--Dec. 8, 2000--Aphton (Nasdaq:APHT - news), a company with products in pivotal and
late-stage clinical trials for cancer therapy, is commencing a clinical trial with patients who have failed the approved
chemotherapy regimen (5-FU and irinotecan) for the treatment of colorectal cancer, stage Dukes` D. Patients will be treated
with a combination regimen of Aphton`s anti-G17 immunogen and irinotecan. Aphton plans to file for a ``fast track`` marketing
approval when a sufficient number of such ``chemo-refractive`` terminal patients respond to the treatment.
Aphton is now in the process of enlisting clinical trial sites and investigators in the US to participate in this trial, which is being
conducted under an IND in place with the US FDA. Aphton is also evaluating the design and timing of a similar trial in Europe.
Aphton is also currently conducting pivotal and other advanced phase clinical trials in the US and Europe for pancreatic,
colorectal and gastric cancer patients. (See previous Aphton news releases.)
Colorectal cancer is the second most common cause of cancer death in the Western world. Its rate of incidence increases
steeply with age. Presently, in the US alone, there are an estimated 760,000 people with diagnosed colorectal cancer, with
more than 130,000 new cases being diagnosed yearly. Of the 760,000 patient total, over 40% are expected to die within the
next 5 years. A large majority of the approximately 60,000 patients who will die during the year 2000 (as estimated by the
American Cancer Society) will have been treated with chemotherapy that failed when they became unresponsive, a condition
referred to as chemo-refractory. With the prognosis so grim, the need for improved colorectal cancer therapy, particularly for
chemo-refractory patients, is large and urgent.
Aphton`s anti-gastrin therapy represents a unique, non-toxic and innovative biological treatment for patients suffering from
gastrointestinal system cancers. Aphton`s anti-gastrin drug induces a directed antibody response against gastrin and other
gastrin-related growth factors. Gastrin has been established as a central hormonal growth factor that stimulates gastrointestinal
cancer cells to proliferate and spread.
Aphton Corporation is a biopharmaceutical company in late-stage, pivotal Phase III clinical trials. Aphton is developing
products using its innovative vaccine-like technology for neutralizing, and removing from circulation, hormones that participate in
gastrointestinal system and reproductive system diseases, both cancer and non-cancer. Aphton is also developing products for
neutralizing hormones to prevent pregnancy. Aphton has strategic alliances with Aventis Pasteur (NYSE:AVE - news),
SmithKline Beecham PLC (NYSE:SBH - news), Schering Plough Animal Health (NYSE:SGP - news) and the World Health
Organization (WHO).
Except for the historical information herein, the matters discussed herein include forward-looking statements that may involve a
number of risks and uncertainties. Future results may vary significantly based on a number of factors including, but not limited
to, intellectual property risks, risks in regulatory and market acceptance of new products and continuing demand for same, the
impact of competitive products and pricing, changing economic conditions and other risk factors detailed in Aphton`s most
recent 10-K and other filings with the Securities and Exchange Commission.
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