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f**********g
发帖数: 2252 | 1 SLOW COW.
Publication Highlights Allovectin-7(R) Phase 2 Safety and Efficacy Results
in Melanoma
6 hours 15 minutes ago - PMZ
GlobeNewswireVical Incorporated (Nasdaq:VICL) today announced a new
publication summarizing results from the company's completed trials of
Allovectin-7(R) including systemic responses and an excellent safety profile
in patients with metastatic melanoma. An article published in the January
issue of Immunotherapy1 noted that the U.S. incidence of melanoma is
increasing rapidly, that current therapies are inadequate and toxic, and
that melanoma is responsive to immune-stimulating drugs like Allovectin-7(R)
. A Phase 3 trial evaluating the safety and efficacy of Allovectin-7(R)
compared with standard chemotherapy is expected to complete final follow-ups
later this year.
The most recently completed Phase 2 trial was a single-arm, open-label study
in which 127 chemo-refractory or chemo-intolerant subjects were treated
with high-dose Allovectin-7(R). There were no treatment-related Grade 3 or
Grade 4 adverse events, and no withdrawals from the trial for tolerability.
The overall response rate for the 127 patients receiving the high-dose
treatment was 11.8%, with 4 complete responders and 11 partial responders.
The median duration of response was 13.8 months and median survival was 18.8
months. These data compare favorably against historical controls from other
studies in metastatic melanoma.
Findings from the Phase 2 trial were incorporated into the design of a Phase
3 pivotal trial through a Special Protocol Assessment agreement with the U.
S. Food and Drug Administration (FDA):
-- The Phase 3 trial sought patients likely to have functional immune
systems.
-- Vical's Phase 3 trial was among the first for metastatic melanoma to
exclude patients with elevated levels of lactate dehydrogenase (LDH),
a
key biomarker predictive of prognosis.
-- The trial excluded patients previously treated with chemotherapy.
-- The Phase 3 trial sought patients healthy enough to remain on study
for
at least two 8-week treatment cycles, the median time to response in
the
Phase 2 study.
-- The trial excluded patients with metastases to the brain or liver.
-- Response Evaluation Criteria In Solid Tumors (RECIST) standards were
modified for the Phase 3 protocol to allow treatment continuation
through two cycles at the physician's discretion, even if patients
develop new melanoma lesions within defined limits.
-- Vical's Phase 3 trial was designed to capture the long-term benefits
of
immunotherapy compared with chemotherapy, as all responses in the
Phase
2 trial were durable (greater then or equal 6 months).
-- The primary endpoint compares overall response rates at 24 weeks or
more
after randomization.
-- The study will also evaluate survival as well as safety and
tolerability.
The Phase 3 trial, initiated in January 2007, is evaluating Allovectin-7(R)
as first-line therapy in patients with Stage III or IV recurrent metastatic
melanoma. Vical completed enrollment in February 2010 of approximately 390
chemo-naive patients randomized on a 2:1 basis: approximately 260 for
treatment with Allovectin-7(R) and approximately 130 for treatment with
either dacarbazine or temozolomide. The company expects to complete patient
follow-up and lock the Phase 3 clinical trial database in the second half of
2011.
Allovectin-7(R) is a novel gene-based immunotherapeutic with a unique
mechanism of action that is fundamentally different from currently approved
treatments, and has the potential to be the first new primary treatment
approved for metastatic melanoma in nearly 20 years. Vical estimates that
the worldwide market for Allovectin-7(R) as a treatment for metastatic
melanoma could exceed $500 million annually, and applications for other
types of cancer could further expand its total use.
Because the mechanism of action for Allovectin-7(R) is not melanoma-specific
, it has the potential to be used in other types of solid tumors. AnGes MG,
Inc., has licensed rights to commercialize Allovectin-7(R) in specified
Asian countries, and is primarily interested in developing Allovectin-7(R)
as a treatment for head and neck cancer, which presents a significant unmet
medical need in Asia. Allovectin-7(R) is still available for licensing in
North America, Europe and other regions.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the company'
s DNA delivery technology include DNA vaccines for infectious diseases or
cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at www.vical.com.
The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768
This press release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include whether Vical or others
will continue developing Allovectin-7(R); whether Allovectin-7(R) will be
approved as primary treatment for metastatic melanoma in the United States
or any other countries; whether the Phase 3 trial will meet its primary
endpoint or any other trial endpoints; whether Allovectin-7(R) will achieve
a higher response rate than chemotherapy after 24 weeks or more; whether any
patients will derive benefit from treatment with Allovectin-7(R); whether
the safety profile of Allovectin-7(R) will continue through trial completion
; whether Allovectin-7(R) will generate revenues exceeding $500 million
annually for metastatic melanoma, if any; whether Allovectin-7(R) will be
successfully developed and commercialized for other solid tumor indications;
whether AnGes will develop or commercialize Allovectin-7(R) in Asia for
head and neck cancer or any other indication; whether any product candidates
will be shown to be safe and effective in clinical trials; the timing,
nature and cost of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market any product candidates;
whether Vical or its collaborative partners will succeed in marketing any
product candidates; and additional risks set forth in the company's filings
with the Securities and Exchange Commission. These forward-looking
statements represent the company's judgment as of the date of this release.
The company disclaims, however, any intent or obligation to update these
forward-looking statements.
1Chowdhery R & Gonzalez R. Immunologic therapy targeting metastatic melanoma
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Vical Incorporated
CONTACT: Alan R. Engbring
(858) 646-1127
Website: www.vical.com | v**********m
发帖数: 5516 | 2 This one is good.
Important news will come out in the 2nd quarter of 2011. | v**********m
发帖数: 5516 | | f******k
发帖数: 87 | | g*********1
发帖数: 725 | 5 银杏大虾的PICK一定跟。可惜才跟了500股。
profile
【在 f**********g 的大作中提到】
: SLOW COW.
: Publication Highlights Allovectin-7(R) Phase 2 Safety and Efficacy Results
: in Melanoma
: 6 hours 15 minutes ago - PMZ
: GlobeNewswireVical Incorporated (Nasdaq:VICL) today announced a new
: publication summarizing results from the company's completed trials of
: Allovectin-7(R) including systemic responses and an excellent safety profile
: in patients with metastatic melanoma. An article published in the January
: issue of Immunotherapy1 noted that the U.S. incidence of melanoma is
: increasing rapidly, that current therapies are inadequate and toxic, and
| y*****l
发帖数: 5997 | 6 这个要问银杏了，从图上看长期目标价3块，4块：
http://finviz.com/screener.ashx?v=341&t=VICL
【在 f******k 的大作中提到】
: any target price?
| f**********g
发帖数: 2252 | 7 SLOW COW.
Publication Highlights Allovectin-7(R) Phase 2 Safety and Efficacy Results
in Melanoma
6 hours 15 minutes ago - PMZ
GlobeNewswireVical Incorporated (Nasdaq:VICL) today announced a new
publication summarizing results from the company's completed trials of
Allovectin-7(R) including systemic responses and an excellent safety profile
in patients with metastatic melanoma. An article published in the January
issue of Immunotherapy1 noted that the U.S. incidence of melanoma is
increasing rapidly, that current therapies are inadequate and toxic, and
that melanoma is responsive to immune-stimulating drugs like Allovectin-7(R)
. A Phase 3 trial evaluating the safety and efficacy of Allovectin-7(R)
compared with standard chemotherapy is expected to complete final follow-ups
later this year.
The most recently completed Phase 2 trial was a single-arm, open-label study
in which 127 chemo-refractory or chemo-intolerant subjects were treated
with high-dose Allovectin-7(R). There were no treatment-related Grade 3 or
Grade 4 adverse events, and no withdrawals from the trial for tolerability.
The overall response rate for the 127 patients receiving the high-dose
treatment was 11.8%, with 4 complete responders and 11 partial responders.
The median duration of response was 13.8 months and median survival was 18.8
months. These data compare favorably against historical controls from other
studies in metastatic melanoma.
Findings from the Phase 2 trial were incorporated into the design of a Phase
3 pivotal trial through a Special Protocol Assessment agreement with the U.
S. Food and Drug Administration (FDA):
-- The Phase 3 trial sought patients likely to have functional immune
systems.
-- Vical's Phase 3 trial was among the first for metastatic melanoma to
exclude patients with elevated levels of lactate dehydrogenase (LDH),
a
key biomarker predictive of prognosis.
-- The trial excluded patients previously treated with chemotherapy.
-- The Phase 3 trial sought patients healthy enough to remain on study
for
at least two 8-week treatment cycles, the median time to response in
the
Phase 2 study.
-- The trial excluded patients with metastases to the brain or liver.
-- Response Evaluation Criteria In Solid Tumors (RECIST) standards were
modified for the Phase 3 protocol to allow treatment continuation
through two cycles at the physician's discretion, even if patients
develop new melanoma lesions within defined limits.
-- Vical's Phase 3 trial was designed to capture the long-term benefits
of
immunotherapy compared with chemotherapy, as all responses in the
Phase
2 trial were durable (greater then or equal 6 months).
-- The primary endpoint compares overall response rates at 24 weeks or
more
after randomization.
-- The study will also evaluate survival as well as safety and
tolerability.
The Phase 3 trial, initiated in January 2007, is evaluating Allovectin-7(R)
as first-line therapy in patients with Stage III or IV recurrent metastatic
melanoma. Vical completed enrollment in February 2010 of approximately 390
chemo-naive patients randomized on a 2:1 basis: approximately 260 for
treatment with Allovectin-7(R) and approximately 130 for treatment with
either dacarbazine or temozolomide. The company expects to complete patient
follow-up and lock the Phase 3 clinical trial database in the second half of
2011.
Allovectin-7(R) is a novel gene-based immunotherapeutic with a unique
mechanism of action that is fundamentally different from currently approved
treatments, and has the potential to be the first new primary treatment
approved for metastatic melanoma in nearly 20 years. Vical estimates that
the worldwide market for Allovectin-7(R) as a treatment for metastatic
melanoma could exceed $500 million annually, and applications for other
types of cancer could further expand its total use.
Because the mechanism of action for Allovectin-7(R) is not melanoma-specific
, it has the potential to be used in other types of solid tumors. AnGes MG,
Inc., has licensed rights to commercialize Allovectin-7(R) in specified
Asian countries, and is primarily interested in developing Allovectin-7(R)
as a treatment for head and neck cancer, which presents a significant unmet
medical need in Asia. Allovectin-7(R) is still available for licensing in
North America, Europe and other regions.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the company'
s DNA delivery technology include DNA vaccines for infectious diseases or
cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at www.vical.com.
The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768
This press release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include whether Vical or others
will continue developing Allovectin-7(R); whether Allovectin-7(R) will be
approved as primary treatment for metastatic melanoma in the United States
or any other countries; whether the Phase 3 trial will meet its primary
endpoint or any other trial endpoints; whether Allovectin-7(R) will achieve
a higher response rate than chemotherapy after 24 weeks or more; whether any
patients will derive benefit from treatment with Allovectin-7(R); whether
the safety profile of Allovectin-7(R) will continue through trial completion
; whether Allovectin-7(R) will generate revenues exceeding $500 million
annually for metastatic melanoma, if any; whether Allovectin-7(R) will be
successfully developed and commercialized for other solid tumor indications;
whether AnGes will develop or commercialize Allovectin-7(R) in Asia for
head and neck cancer or any other indication; whether any product candidates
will be shown to be safe and effective in clinical trials; the timing,
nature and cost of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market any product candidates;
whether Vical or its collaborative partners will succeed in marketing any
product candidates; and additional risks set forth in the company's filings
with the Securities and Exchange Commission. These forward-looking
statements represent the company's judgment as of the date of this release.
The company disclaims, however, any intent or obligation to update these
forward-looking statements.
1Chowdhery R & Gonzalez R. Immunologic therapy targeting metastatic melanoma
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Vical Incorporated
CONTACT: Alan R. Engbring
(858) 646-1127
Website: www.vical.com | v**********m
发帖数: 5516 | 8 This one is good.
Important news will come out in the 2nd quarter of 2011. | v**********m
发帖数: 5516 | | f******k
发帖数: 87 | | g*********1
发帖数: 725 | 11 银杏大虾的PICK一定跟。可惜才跟了500股。
profile
【在 f**********g 的大作中提到】
: SLOW COW.
: Publication Highlights Allovectin-7(R) Phase 2 Safety and Efficacy Results
: in Melanoma
: 6 hours 15 minutes ago - PMZ
: GlobeNewswireVical Incorporated (Nasdaq:VICL) today announced a new
: publication summarizing results from the company's completed trials of
: Allovectin-7(R) including systemic responses and an excellent safety profile
: in patients with metastatic melanoma. An article published in the January
: issue of Immunotherapy1 noted that the U.S. incidence of melanoma is
: increasing rapidly, that current therapies are inadequate and toxic, and
| y*****l
发帖数: 5997 | 12 这个要问银杏了，从图上看长期目标价3块，4块：
http://finviz.com/screener.ashx?v=341&t=VICL
【在 f******k 的大作中提到】
: any target price?
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