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Name: OPHIDIAN PHARMACEUTICALS INC.
WKN. 914159
Symbo USAl: OPHD
OPHIDIAN PHARMACEUTICALS
INC (OPHD.OB)
Quarterly Report (SEC form 10-Q)
ITEM 2 MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion of the financial condition and results of operations of the Company should be read in conjunction with the
financial statements and the related notes thereto included in this document. This document contains certain forward-looking
statements that involve risks and uncertainties. These forward-looking statements are made in reliance upon the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that the Company`s actual
results may differ significantly from the results anticipated in these forward-looking statements as a result of various factors.
Such factors include, but are not limited to, those set forth in the section titled "Risk Factors" (pages 7-18) of the Company`s
Prospectus, which is part of the Company`s Registration Statement, filed on Form S-1, as amended, effective May 7, 1998, and
summarized in its Annual Report for Fiscal 2000, filed on Form 10-K, effective December 29, 2000. The Company undertakes no
obligation to revise such forward-looking statements to reflect events or circumstances occurring after the date hereof.
OVERVIEW
The Company was incorporated on November 10, 1989, and commenced business operations on January 17, 1990. Primary
business efforts were directed at the design, development and commercialization of cost effective therapeutic and diagnostic
products for human and animal use, focusing principally on products for the prevention and treatment of infectious diseases. On
May 26, 2000, due to lack of financing, the Company`s Board of Directors took action to cease operations as a going concern,
reducing the Company`s workforce 80% by laying off research, development and operations personnel. Remaining management
staff were retained for a reasonable time to wind down clinical trial and manufacturing operations and to continue efforts to
actively seek potential commercial partners having strategic interests in markets served by the Company`s products. Since
mid-August 2000 the Company has retained only one Board-appointed administrative staff member to execute operations.
On August 28, 2000, the Company`s Board of Directors adopted resolutions to approve an Asset Purchase Agreement (the "Sale
Agreement") with Promega Corporation ("Promega") and to effect the subsequent dissolution of the Company. On September 1,
2000, the Company executed the Sale Agreement with Promega to sell substantially all of its fixed assets for $1,250,000 cash, a
$250,000 promissory note, and the assumption of long-term debt of $2,000,000 (the "Asset Sale"). The promissory note was
subject to certain post-closing adjustments within 90 days of the closing, as set forth in the Sale Agreement. Stockholders of the
Company approved the Sale Agreement on November 9, 2000, and authorized the Board to effect the liquidation and dissolution
of the Company pursuant to an approved Plan of Dissolution. The Asset Sale closed on November 16, 2000. The $1,250,000 cash
amount was offset by $101,255 for existing amounts payable to Promega. The net proceeds of $1,148,745 were paid to the
Company in cash. The Promissory Note was reduced by $80,000 to reflect higher than scheduled rent payments on the
Company`s lease of its manufacturing facility, which lease was assumed by Promega. The Promissory Note was reduced by an
additional $10,000 by Promega pending investigation of a purported irregularity related to the plumbing system at the
manufacturing facility. The Promissory Note matured on January 29, 2001. The Company received a cash payment of $160,986
against the Promissory Note on January 29, 2001. The cash amount included payment of 3% interest on the Promissory Note
based upon the terms of the Asset Purchase Agreement. The purported irregularity related to the plumbing system at the
manufacturing facility was resolved and the Company received a final cash payment of $10,000 plus interest on March 15, 2001.
The Company`s Common Stock was delisted from the NASDAQ SmallCap Market effective November 7, 2000, because the
aggregate value of the public float fell below the NASDAQ requirement of $1,000,000. The Company`s Common Stock was
delisted from the Pacific Exchange effective November 10, 2000, based on the Company`s announcement of stockholder
approval of proposals to sell substantially all of the Company`s assets and to authorize the Board of Directors to implement a plan
to liquidate, wind up, and dissolve the Company. Trading and quotation of the Company`s stock is now available through the OTC
(Over-the-Counter) Bulletin Board quotation service under the symbol "OPHD".
On January 2, 2001, the Company entered into a letter of intent to effect a merger with HEMOXymed, Inc., a privately held,
development stage corporation with its principal offices in Charlottesville, Virginia ("Hemoxymed"). Pursuant to the terms
included in the letter of intent, Hemoxymed placed $60,000 in escrow to cover expenses incurred by the Company in the process
of effecting the merger, including preparing and distributing a proxy statement to the Company`s stockholders to solicit their
approval and adoption of a plan of merger and for any other legal or administrative costs associated with a merger. Any unused
portion of the escrowed amount will be returned to Hemoxymed at the time the merger is finalized. The escrowed amount is not
recorded in the Company`s financial statements.
On April 16, 2001, an Agreement and Plan of Merger was executed between the Company and Hemoxymed. Refer to Note 2 of
the financial statements for details. If the agreement is subsequently approved by the stockholders of both companies, it is the
Board of Directors` intention to complete the transaction with Hemoxymed. If for any reason the transaction with Hemoxymed is
not consummated, it is the Board of Directors` intention to proceed with the Plan of Dissolution as approved by stockholders on
November 9, 2000.
RESULTS OF OPERATIONS
The financial statements for the six-month period ended March 31, 2001, were prepared using the liquidation basis of accounting,
which differs from the going-concern basis of accounting used to prepare the financial statements for the six-month period ended
March 31, 2000. See Note 1 to the accompanying financial statements.
LIQUIDATION OF THE COMPANY
As previously announced, the Company sold substantially all of its fixed assets and intellectual property to Promega on November
16, 2000. A distribution of cash remaining after payment of the Company`s operational and accrued costs was made on April 30,
2001, to stockholders of record as of April 23, 2001. Since August 2000 there has been one administrative employee retained to
carry out business associated with the Plan of Dissolution that was approved by stockholders on November 9, 2000. The
Agreement and Plan of Merger with Hemoxymed will require stockholder approval. A Proxy Statement will be prepared and
distributed to stockholders in conjunction with a stockholder`s meeting to be held in June, 2001. If the Agreement and Plan of
Merger is approved, the Company will complete the merger with Hemoxymed as soon as administratively feasible.
Max Depot Anteil 2%
mfg
Breule
WKN. 914159
Symbo USAl: OPHD
OPHIDIAN PHARMACEUTICALS
INC (OPHD.OB)
Quarterly Report (SEC form 10-Q)
ITEM 2 MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion of the financial condition and results of operations of the Company should be read in conjunction with the
financial statements and the related notes thereto included in this document. This document contains certain forward-looking
statements that involve risks and uncertainties. These forward-looking statements are made in reliance upon the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that the Company`s actual
results may differ significantly from the results anticipated in these forward-looking statements as a result of various factors.
Such factors include, but are not limited to, those set forth in the section titled "Risk Factors" (pages 7-18) of the Company`s
Prospectus, which is part of the Company`s Registration Statement, filed on Form S-1, as amended, effective May 7, 1998, and
summarized in its Annual Report for Fiscal 2000, filed on Form 10-K, effective December 29, 2000. The Company undertakes no
obligation to revise such forward-looking statements to reflect events or circumstances occurring after the date hereof.
OVERVIEW
The Company was incorporated on November 10, 1989, and commenced business operations on January 17, 1990. Primary
business efforts were directed at the design, development and commercialization of cost effective therapeutic and diagnostic
products for human and animal use, focusing principally on products for the prevention and treatment of infectious diseases. On
May 26, 2000, due to lack of financing, the Company`s Board of Directors took action to cease operations as a going concern,
reducing the Company`s workforce 80% by laying off research, development and operations personnel. Remaining management
staff were retained for a reasonable time to wind down clinical trial and manufacturing operations and to continue efforts to
actively seek potential commercial partners having strategic interests in markets served by the Company`s products. Since
mid-August 2000 the Company has retained only one Board-appointed administrative staff member to execute operations.
On August 28, 2000, the Company`s Board of Directors adopted resolutions to approve an Asset Purchase Agreement (the "Sale
Agreement") with Promega Corporation ("Promega") and to effect the subsequent dissolution of the Company. On September 1,
2000, the Company executed the Sale Agreement with Promega to sell substantially all of its fixed assets for $1,250,000 cash, a
$250,000 promissory note, and the assumption of long-term debt of $2,000,000 (the "Asset Sale"). The promissory note was
subject to certain post-closing adjustments within 90 days of the closing, as set forth in the Sale Agreement. Stockholders of the
Company approved the Sale Agreement on November 9, 2000, and authorized the Board to effect the liquidation and dissolution
of the Company pursuant to an approved Plan of Dissolution. The Asset Sale closed on November 16, 2000. The $1,250,000 cash
amount was offset by $101,255 for existing amounts payable to Promega. The net proceeds of $1,148,745 were paid to the
Company in cash. The Promissory Note was reduced by $80,000 to reflect higher than scheduled rent payments on the
Company`s lease of its manufacturing facility, which lease was assumed by Promega. The Promissory Note was reduced by an
additional $10,000 by Promega pending investigation of a purported irregularity related to the plumbing system at the
manufacturing facility. The Promissory Note matured on January 29, 2001. The Company received a cash payment of $160,986
against the Promissory Note on January 29, 2001. The cash amount included payment of 3% interest on the Promissory Note
based upon the terms of the Asset Purchase Agreement. The purported irregularity related to the plumbing system at the
manufacturing facility was resolved and the Company received a final cash payment of $10,000 plus interest on March 15, 2001.
The Company`s Common Stock was delisted from the NASDAQ SmallCap Market effective November 7, 2000, because the
aggregate value of the public float fell below the NASDAQ requirement of $1,000,000. The Company`s Common Stock was
delisted from the Pacific Exchange effective November 10, 2000, based on the Company`s announcement of stockholder
approval of proposals to sell substantially all of the Company`s assets and to authorize the Board of Directors to implement a plan
to liquidate, wind up, and dissolve the Company. Trading and quotation of the Company`s stock is now available through the OTC
(Over-the-Counter) Bulletin Board quotation service under the symbol "OPHD".
On January 2, 2001, the Company entered into a letter of intent to effect a merger with HEMOXymed, Inc., a privately held,
development stage corporation with its principal offices in Charlottesville, Virginia ("Hemoxymed"). Pursuant to the terms
included in the letter of intent, Hemoxymed placed $60,000 in escrow to cover expenses incurred by the Company in the process
of effecting the merger, including preparing and distributing a proxy statement to the Company`s stockholders to solicit their
approval and adoption of a plan of merger and for any other legal or administrative costs associated with a merger. Any unused
portion of the escrowed amount will be returned to Hemoxymed at the time the merger is finalized. The escrowed amount is not
recorded in the Company`s financial statements.
On April 16, 2001, an Agreement and Plan of Merger was executed between the Company and Hemoxymed. Refer to Note 2 of
the financial statements for details. If the agreement is subsequently approved by the stockholders of both companies, it is the
Board of Directors` intention to complete the transaction with Hemoxymed. If for any reason the transaction with Hemoxymed is
not consummated, it is the Board of Directors` intention to proceed with the Plan of Dissolution as approved by stockholders on
November 9, 2000.
RESULTS OF OPERATIONS
The financial statements for the six-month period ended March 31, 2001, were prepared using the liquidation basis of accounting,
which differs from the going-concern basis of accounting used to prepare the financial statements for the six-month period ended
March 31, 2000. See Note 1 to the accompanying financial statements.
LIQUIDATION OF THE COMPANY
As previously announced, the Company sold substantially all of its fixed assets and intellectual property to Promega on November
16, 2000. A distribution of cash remaining after payment of the Company`s operational and accrued costs was made on April 30,
2001, to stockholders of record as of April 23, 2001. Since August 2000 there has been one administrative employee retained to
carry out business associated with the Plan of Dissolution that was approved by stockholders on November 9, 2000. The
Agreement and Plan of Merger with Hemoxymed will require stockholder approval. A Proxy Statement will be prepared and
distributed to stockholders in conjunction with a stockholder`s meeting to be held in June, 2001. If the Agreement and Plan of
Merger is approved, the Company will complete the merger with Hemoxymed as soon as administratively feasible.
Max Depot Anteil 2%
mfg
Breule
Name: CORVAS INTERNATIONAL
WKN. 883462
Symbol USA: CVAS
Homepage: http://www.corvas.com
Product Pipeline
Corvas Completes Phase IIa Angioplasty Trial With
rNAPc2 Anticoagulant
SAN DIEGO, June 6 /PRNewswire/ -- Corvas International, Inc. (Nasdaq: CVAS - news) today announced that it has
completed the planned enrollment of the multi-center, Phase IIa safety trial of the proprietary injectable anticoagulant,
recombinant Nematode Anticoagulant Protein c2 or rNAPc2, in patients undergoing elective percutaneous transluminal coronary
angioplasty (PTCA). Following un-blinding and analysis of the data set, the final results from this trial will be available later this
year.
The primary goal of this study was to determine the safety of rNAPc2 administered to patients undergoing elective PTCA by
determining the groin compression time and the incidence of major and minor bleeding. The groin compression time is a
measurement of the patient`s coagulation response to a surgical incision used in the PTCA procedure. The more prolonged the
groin compression time from normal, the greater anticoagulant effect of rNAPc2. Secondary objectives included the
measurement of selected biochemical markers related to the activity of the blood coagulation process and platelet activation. The
safety data obtained from this Phase IIa trial will be used in the design of future clinical studies evaluating rNAPc2 in patients
with acute coronary syndromes, such as unstable angina, since many of these patients undergo coronary intervention procedures
including PTCA and stent placement.
Including the recently completed Phase IIa PTCA trial, rNAPc2 has been evaluated in approximately 500 patients and healthy
volunteers in several Phase I studies as well as a Phase II trial which demonstrated the safety and efficacy of rNAPc2 in the
prevention of deep vein thrombosis (DVT) following unilateral knee replacement. Based on these Phase II results, Corvas intends
to initiate two Phase III clinical trials later this year which will compare rNAPc2 to low molecular weight heparin for the
prevention of DVT in patients undergoing major orthopedic surgery.
The Phase IIa PTCA trial was a randomized, placebo-controlled, double-blinded, dose-escalation study. Each of the five
treatment cohorts consisted of at least 30 patients that received either standard therapy with unfractionated heparin and aspirin or
standard therapy plus rNAPc2 administered as a single subcutaneous injection prior to the PTCA procedure. Many of the
patients also received the anti-platelet agent clopidogrel (Plavix®) and to a lesser extent glycoprotein IIb/IIIa platelet receptor
antagonists. Approximately half of the patients underwent coronary stent placement. The study was conducted exclusively at
clinical centers in The Netherlands.
``The safety data from this trial is an important step in the evaluation of rNAPc2 as an alternative anticoagulant strategy in
patients suffering from acute coronary syndromes. This trial adds to our overall clinical experience with rNAPc2 as we continue
to broaden the range of clinical indications for this novel anticoagulant,`` stated Dr. George P. Vlasuk, Chief Scientific Officer at
Corvas.
The treatment of acute coronary syndromes such as unstable angina and non-Q-wave myocardial infarction represents a
significant potential expansion of the market opportunity for rNAPc2. In both the United States and Europe, acute coronary
syndrome accounts for more than 1 million hospital admissions annually. Despite current treatments, 10-20% of patients suffering
from acute coronary syndrome experience additional severe events such as death or myocardial infarction within six months.
The rNAPc2 protein was originally derived in blood-feeding hookworms, and is currently manufactured as a recombinant protein
for clinical use. The anticoagulant effect of rNAPc2 results from its ability to block the factor VIIa/tissue factor protease
complex which initiates the first step in the cascade of biochemical events resulting in the formation of blood clots (thrombosis).
Corvas International, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel
therapeutics that address large markets, including cardiovascular disease, stroke and cancer.
This press release, as well as the Company`s SEC filings and web site at http://www.corvas.com, contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements concerning the
current and future clinical trials, potential benefits of rNAPc2 as a drug, and the estimated size of the market. Actual results could
vary materially from those described as a result of a number of factors, including those set forth in Corvas` Annual Report on
Form 10-K and any subsequent SEC filings. In addition, there is the risk that the two Phase III clinical trials for rNAPc2 for the
prevention of DVT in patients undergoing major orthopedic surgery will not commence in the fourth quarter of this year and if
commenced, will not be successful, that the Phase IIa clinical trial described above will not be successful, that Corvas may not
broaden the range of clinical indications for rNAPc2 and that rNAPc2 or other drug candidates in Corvas` pipeline may never
become marketable products. The Company undertakes no obligation to revise or update these forward-looking statements to
reflect events or circumstances after the date of this press release, except as required by law.
Yearly Earnings Forecasts and Quarterly Earnings Forecasts
http://earnings.nasdaq.com/earnings/earnings_forecast.asp?s…
Max Depot Anteil 4% Sollte ein 100% werden
mfg
Breule
WKN. 883462
Symbol USA: CVAS
Homepage: http://www.corvas.com
Product Pipeline
Corvas Completes Phase IIa Angioplasty Trial With
rNAPc2 Anticoagulant
SAN DIEGO, June 6 /PRNewswire/ -- Corvas International, Inc. (Nasdaq: CVAS - news) today announced that it has
completed the planned enrollment of the multi-center, Phase IIa safety trial of the proprietary injectable anticoagulant,
recombinant Nematode Anticoagulant Protein c2 or rNAPc2, in patients undergoing elective percutaneous transluminal coronary
angioplasty (PTCA). Following un-blinding and analysis of the data set, the final results from this trial will be available later this
year.
The primary goal of this study was to determine the safety of rNAPc2 administered to patients undergoing elective PTCA by
determining the groin compression time and the incidence of major and minor bleeding. The groin compression time is a
measurement of the patient`s coagulation response to a surgical incision used in the PTCA procedure. The more prolonged the
groin compression time from normal, the greater anticoagulant effect of rNAPc2. Secondary objectives included the
measurement of selected biochemical markers related to the activity of the blood coagulation process and platelet activation. The
safety data obtained from this Phase IIa trial will be used in the design of future clinical studies evaluating rNAPc2 in patients
with acute coronary syndromes, such as unstable angina, since many of these patients undergo coronary intervention procedures
including PTCA and stent placement.
Including the recently completed Phase IIa PTCA trial, rNAPc2 has been evaluated in approximately 500 patients and healthy
volunteers in several Phase I studies as well as a Phase II trial which demonstrated the safety and efficacy of rNAPc2 in the
prevention of deep vein thrombosis (DVT) following unilateral knee replacement. Based on these Phase II results, Corvas intends
to initiate two Phase III clinical trials later this year which will compare rNAPc2 to low molecular weight heparin for the
prevention of DVT in patients undergoing major orthopedic surgery.
The Phase IIa PTCA trial was a randomized, placebo-controlled, double-blinded, dose-escalation study. Each of the five
treatment cohorts consisted of at least 30 patients that received either standard therapy with unfractionated heparin and aspirin or
standard therapy plus rNAPc2 administered as a single subcutaneous injection prior to the PTCA procedure. Many of the
patients also received the anti-platelet agent clopidogrel (Plavix®) and to a lesser extent glycoprotein IIb/IIIa platelet receptor
antagonists. Approximately half of the patients underwent coronary stent placement. The study was conducted exclusively at
clinical centers in The Netherlands.
``The safety data from this trial is an important step in the evaluation of rNAPc2 as an alternative anticoagulant strategy in
patients suffering from acute coronary syndromes. This trial adds to our overall clinical experience with rNAPc2 as we continue
to broaden the range of clinical indications for this novel anticoagulant,`` stated Dr. George P. Vlasuk, Chief Scientific Officer at
Corvas.
The treatment of acute coronary syndromes such as unstable angina and non-Q-wave myocardial infarction represents a
significant potential expansion of the market opportunity for rNAPc2. In both the United States and Europe, acute coronary
syndrome accounts for more than 1 million hospital admissions annually. Despite current treatments, 10-20% of patients suffering
from acute coronary syndrome experience additional severe events such as death or myocardial infarction within six months.
The rNAPc2 protein was originally derived in blood-feeding hookworms, and is currently manufactured as a recombinant protein
for clinical use. The anticoagulant effect of rNAPc2 results from its ability to block the factor VIIa/tissue factor protease
complex which initiates the first step in the cascade of biochemical events resulting in the formation of blood clots (thrombosis).
Corvas International, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel
therapeutics that address large markets, including cardiovascular disease, stroke and cancer.
This press release, as well as the Company`s SEC filings and web site at http://www.corvas.com, contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements concerning the
current and future clinical trials, potential benefits of rNAPc2 as a drug, and the estimated size of the market. Actual results could
vary materially from those described as a result of a number of factors, including those set forth in Corvas` Annual Report on
Form 10-K and any subsequent SEC filings. In addition, there is the risk that the two Phase III clinical trials for rNAPc2 for the
prevention of DVT in patients undergoing major orthopedic surgery will not commence in the fourth quarter of this year and if
commenced, will not be successful, that the Phase IIa clinical trial described above will not be successful, that Corvas may not
broaden the range of clinical indications for rNAPc2 and that rNAPc2 or other drug candidates in Corvas` pipeline may never
become marketable products. The Company undertakes no obligation to revise or update these forward-looking statements to
reflect events or circumstances after the date of this press release, except as required by law.
Yearly Earnings Forecasts and Quarterly Earnings Forecasts
http://earnings.nasdaq.com/earnings/earnings_forecast.asp?s…
Max Depot Anteil 4% Sollte ein 100% werden
mfg
Breule
Name: Dendreon
WKN. 615606
Symbol USA: DNDN
Homepage: http://www.dendreon.com
Dendreon Corporation expands clinical trial
program with Phase III trial of Provenge™ for
earlier stage prostate cancer
Seattle, WA (June 11, 2001) - Dendreon Corporation (NASDAQNDN) announced today the
expansion of its clinical trial program for Provenge™, its therapeutic cancer vaccine, with the
initiation of a Phase III trial targeting men with earlier stage prostate cancer. Provenge is
already in Phase III trials for men with advanced hormone refractory prostate cancer.
Dendreon expects its initial Phase III study to be closed on schedule shortly.
"It is fitting that we have chosen the commencement of National Men`s Health Week to
announce expansion of our Provenge clinical trial program to include patients with earlier
stage prostate cancer," said Christopher S. Henney, Ph.D., D.Sc., chief executive officer and
chairman of Dendreon. "Dendreon is committed to the development of a safe and effective
therapeutic product for the treatment of this prevalent disease."
Approximately 15 centers nationwide are involved in the new double blind, placebo-controlled
trial, which will enroll patients who have had their prostate surgically removed, but who have
rising levels of Prostate Specific Antigen (PSA), indicating recurrence of disease. In this new
Provenge trial, treatment will be given subsequent to three months of hormone therapy, a
common therapy for recurrent prostate cancer.
"The exciting thing about this trial is that it uses a modern vaccine approach that works
independently from hormonal therapy," said Edward Messing, M.D., FACS, professor of
urology, oncology and pathology at the University of Rochester Cancer Center in Rochester,
NY and principal investigator of the trial. "What I hope to see is that by immunologic
targeting early in the disease process we can reduce dependence on hormones and
ultimately delay the time that the cancer becomes hormone refractory."
Results of earlier trials in patients with advanced hormone refractory prostate cancer suggest
that Provenge treatment is safe and stimulates immune activity. Tumor regressions have
occurred in some patients, and the vaccine generally appears to delay the progress of
prostate tumors.
To be eligible for the present study, patients must have received a prostatectomy and have
a rising PSA, but no other signs of disease recurrence. Patients who receive placebo will have
the option of receiving the immunotherapy if their disease progresses during the study.
Participating study centers include: Alta Bates Comprehensive Cancer Center (Berkeley,
Calif.), University of Colorado Health Sciences Center (Denver, Colo.), Lutheran General
Cancer Care Center (Park Ridge, Ill.), Mount Sinai School of Medicine (New York, N.Y.),
University of Rochester Medical Center (Rochester, N.Y.), AKSM Clinical Research Corporation
(Columbus, Ohio), Albert Einstein Medical Center (Philadelphia, Pa.), Bryn Mawr Urology (Bryn
Mawr, Pa.), Eastern Virginia Medical School (Norfolk, Va.), Medical College of Virginia
(Richmond, Va.), Oregon Health Sciences University (Portland, Ore.), Providence Medical
Center (Portland, Ore.), The Veteran`s Administration Hospital (Portland, Ore.), Swedish
Medical Center (Seattle, Wash.) and the Virginia Mason Research Center (Seattle, Wash.).
For more information about the trials, please call 1-206-829-1640.
Dendreon Corporation (www.dendreon.com) is dedicated to the discovery and development
of novel products for the treatment of cancer through its innovative manipulation of the
immune system. Dendreon is focused on the development of therapeutic cancer vaccines
through the use of antigen discovery, antigen engineering and dendritic cell technologies.
Except for historical information contained herein, this news release contains forward-looking
statements that are subject to risks and uncertainties that may cause actual results to differ
materially from the results discussed in the forward-looking statements, particularly those
inherent in the process of discovering, developing and commercializing drugs that are safe
and effective for use as human therapeutics. Factors that may cause such a difference
include risks related to Dendreon`s limited operating history, risks associated with completing
our clinical trials, dependence on the efforts of third parties, and our dependence on
intellectual property. Further information on the factors and risks that could affect
Dendreon`s business, financial condition and results of operations, are contained in
Dendreon`s SEC Reports, including Dendreon`s Form 10-K, which are available at
www.sec.gov.
Max Depot - Anteil 4 %
mfg
Breule
WKN. 615606
Symbol USA: DNDN
Homepage: http://www.dendreon.com
Dendreon Corporation expands clinical trial
program with Phase III trial of Provenge™ for
earlier stage prostate cancer
Seattle, WA (June 11, 2001) - Dendreon Corporation (NASDAQNDN) announced today the
expansion of its clinical trial program for Provenge™, its therapeutic cancer vaccine, with the
initiation of a Phase III trial targeting men with earlier stage prostate cancer. Provenge is
already in Phase III trials for men with advanced hormone refractory prostate cancer.
Dendreon expects its initial Phase III study to be closed on schedule shortly.
"It is fitting that we have chosen the commencement of National Men`s Health Week to
announce expansion of our Provenge clinical trial program to include patients with earlier
stage prostate cancer," said Christopher S. Henney, Ph.D., D.Sc., chief executive officer and
chairman of Dendreon. "Dendreon is committed to the development of a safe and effective
therapeutic product for the treatment of this prevalent disease."
Approximately 15 centers nationwide are involved in the new double blind, placebo-controlled
trial, which will enroll patients who have had their prostate surgically removed, but who have
rising levels of Prostate Specific Antigen (PSA), indicating recurrence of disease. In this new
Provenge trial, treatment will be given subsequent to three months of hormone therapy, a
common therapy for recurrent prostate cancer.
"The exciting thing about this trial is that it uses a modern vaccine approach that works
independently from hormonal therapy," said Edward Messing, M.D., FACS, professor of
urology, oncology and pathology at the University of Rochester Cancer Center in Rochester,
NY and principal investigator of the trial. "What I hope to see is that by immunologic
targeting early in the disease process we can reduce dependence on hormones and
ultimately delay the time that the cancer becomes hormone refractory."
Results of earlier trials in patients with advanced hormone refractory prostate cancer suggest
that Provenge treatment is safe and stimulates immune activity. Tumor regressions have
occurred in some patients, and the vaccine generally appears to delay the progress of
prostate tumors.
To be eligible for the present study, patients must have received a prostatectomy and have
a rising PSA, but no other signs of disease recurrence. Patients who receive placebo will have
the option of receiving the immunotherapy if their disease progresses during the study.
Participating study centers include: Alta Bates Comprehensive Cancer Center (Berkeley,
Calif.), University of Colorado Health Sciences Center (Denver, Colo.), Lutheran General
Cancer Care Center (Park Ridge, Ill.), Mount Sinai School of Medicine (New York, N.Y.),
University of Rochester Medical Center (Rochester, N.Y.), AKSM Clinical Research Corporation
(Columbus, Ohio), Albert Einstein Medical Center (Philadelphia, Pa.), Bryn Mawr Urology (Bryn
Mawr, Pa.), Eastern Virginia Medical School (Norfolk, Va.), Medical College of Virginia
(Richmond, Va.), Oregon Health Sciences University (Portland, Ore.), Providence Medical
Center (Portland, Ore.), The Veteran`s Administration Hospital (Portland, Ore.), Swedish
Medical Center (Seattle, Wash.) and the Virginia Mason Research Center (Seattle, Wash.).
For more information about the trials, please call 1-206-829-1640.
Dendreon Corporation (www.dendreon.com) is dedicated to the discovery and development
of novel products for the treatment of cancer through its innovative manipulation of the
immune system. Dendreon is focused on the development of therapeutic cancer vaccines
through the use of antigen discovery, antigen engineering and dendritic cell technologies.
Except for historical information contained herein, this news release contains forward-looking
statements that are subject to risks and uncertainties that may cause actual results to differ
materially from the results discussed in the forward-looking statements, particularly those
inherent in the process of discovering, developing and commercializing drugs that are safe
and effective for use as human therapeutics. Factors that may cause such a difference
include risks related to Dendreon`s limited operating history, risks associated with completing
our clinical trials, dependence on the efforts of third parties, and our dependence on
intellectual property. Further information on the factors and risks that could affect
Dendreon`s business, financial condition and results of operations, are contained in
Dendreon`s SEC Reports, including Dendreon`s Form 10-K, which are available at
www.sec.gov.
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