快要 飞的 《药股》 讨论区

葉芬

CVM pre-market up .. last done  1.15

葉芬

不知麥麥還有HLCS在手嗎。。。

HLCS又大跌多1次。。。
Last 1.02 ！

葉芬

很可能就是今晚 FDA 給她 Approval。。。



A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

This study is currently recruiting participants.
Verified by ACADIA Pharmaceuticals Inc., February 2009

First Received: October 26, 2007   Last Updated: June 16, 2009   History of Changes

Sponsor:         ACADIA Pharmaceuticals Inc.

Information provided by:         ACADIA Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:         NCT00550238


  Purpose

To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

Condition         Intervention         Phase
Parkinson's Disease Psychosis
        Drug: pimavanserin tartrate (ACP-103)
        Phase III

Study Type:         Interventional
Study Design:         Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:         A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease Psychotic Disorders
Drug Information available for: Pimavanserin tartrate ACP 103
U.S. FDA Resources

Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:

    * Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

    * Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]


Estimated Enrollment:         500
Study Start Date:         July 2007
Estimated Primary Completion Date:         December 2009 (Final data collection date for primary outcome measure)
Intervention Details:

      Drug: pimavanserin tartrate (ACP-103)
      tablets once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

  Eligibility

Ages Eligible for Study:           40 Years and older
Genders Eligible for Study:           Both
Accepts Healthy Volunteers:           No
Criteria

Inclusion Criteria:

    * Subject has completed the treatment period of Study ACP-103-012
    * The subject is willing and able to provide consent
    * Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

    * Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
    * Subject is judged by the Investigator to be inappropriate for the study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550238

Contacts
Contact: Kimberly Wilson                 ACP-103clintrials@acadia-pharm.com

  Show 43 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party:         ACADIA Pharmaceuticals Inc. ( Kimberly Wilson )
Study ID Numbers:         ACP-103-015
Study First Received:         October 26, 2007
Last Updated:         June 16, 2009
ClinicalTrials.gov Identifier:         NCT00550238     History of Changes
Health Authority:         United States: Food and Drug Administration

Keywords provided by ACADIA Pharmaceuticals Inc.:
Parkinson's Disease Psychosis

Additional relevant MeSH terms:
Mental Disorders
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
        Psychotic Disorders
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on December 17, 2009

葉芬

AVII 飛了。。。  Last Done 1.65 ！

Miku 你有買進嗎？



AVI BioPharma Says Treatment With AVI-4658 Demonstrates RNA Exon Skipping And Dystrophin Protein Expression In DMD Pati

AVI BioPharma Says Treatment With AVI-4658 Demonstrates RNA Exon Skipping And Dystrophin Protein Expression
In DMD Patients - Quick Facts

Tue Dec 22 07:21:00 2009
EST
(RTTNews) - AVI BioPharma Inc. (AVII) announced initial efficacy data from the ongoing Phase 1b/2
clinical trial of AVI-4658 for the systemic treatment of patients with Duchenne muscular dystrophy or

DMD, a genetic muscle wasting disease caused by failure to produce dystrophin. Patients in the first
four (of six) cohorts completing 12 weeks of treatment with different doses of AVI-4658 (0.5, 1.0, 2.0

or 4.0 mg/kg) have had their muscles biopsied. Analysis of the post treatment biopsies found that patients

in the 2 and 4 mg/kg drug-treatment cohorts (3 of 3 in total) showed correctly spliced mRNA for dystrophin.

One of these patients, in the 2mg/kg cohort, showed robust expression of dystrophin protein by western

blot and immunofluorescent analysis. No RNA or protein expression signal was detected in patients from

the 0.5 mg/kg or 1.0 mg/kg cohorts after completing treatment. Restoration of functional dystrophin
expression is considered critical for successful treatment of DMD, the company said.

Treatment with AVI-4658 in the three patients in the 2.0 and 4.0 mg/kg cohorts led to accurate skipping

of exon 51, which is believed to be necessary to restore the mRNA reading frame for functional dystrophin

expression in patients with this class of mutations.

The company noted that data from patients dosed to date demonstrate that AVI-4658 continues to be
generally very well tolerated. Adverse events reported to date are mostly mild, unrelated to drug treatment

and transient.

葉芬

CVM 今晚有起 0.17， 不過我已經拿票，所以沒有看她。讓她自然飛吧。。。


CEL-SCI Completes Validation of Manufacturing Facility Allowing It To Commence Manufacturing of Multikine Facility Is A

CEL-SCI Completes Validation of Manufacturing Facility Allowing It To Commence Manufacturing of Multikine
Facility Is Also Expected to Generate Revenue Through Contract Manufacturing

Mon Jan 11 09:30:00 2010
EST
VIENNA, Va., Jan 11, 2010 /PRNewswire via COMTEX News Network/ --
CEL-SCI Corporation (NYSE Amex: CVM), a late-stage oncology company and a developer
of vaccines and therapeutics for the prevention and treatment of infectious diseases,
announced today it has completed the validation of all critical utilities and manufacturing
equipment at its GMP manufacturing facility in Maryland. Completion of this validation
effort represents a very important milestone as it allows CEL-SCI to move forward
with its drug manufacturing plans for the investigational cancer drug Multikine(R)
for the upcoming head and neck Phase III clinical trial.  The manufacturing facility
is now also ready to offer Contract Manufacturing services which could commence
following the manufacture of Multikine.
"Reaching this validation milestone represents a major step forward for CEL-SCI,
as it will allow the Company to produce the drug necessary for our pivotal global
Phase III clinical trial," said Geert Kersten, CEO of CEL-SCI. "We believe that
having our own facility gives us greater control over the Multikine manufacturing
process and helps increase the probability of Multikine becoming an approved drug."
The Phase III clinical trial with Multikine will focus on advanced primary
head and neck cancer patients.  It will enroll approximately 800 patients in about
11 countries around the world and will evaluate Multikine's ability to increase
the overall survival of treated patients when used in conjunction with the current
standard of care treatment.
The clinical need is great as treatment prospects for these patients have
not improved much over the past decades, the market is very large and since CEL-SCI
has all of the major marketing rights, the potential is very significant.  Head
and neck cancer represents about 6% of all of the world's cancer.
In Phase II clinical trials Multikine was shown to be safe and well-tolerated,
and to improve patients' overall survival by 33% over what can be attained with
standard treatment alone (without the addition of Multikine therapy) at a median
of three and a half years following surgery. The U.S. Food and Drug Administration
(FDA) gave the go-ahead for this Phase III clinical trial and granted orphan drug
status to Multikine in the neoadjuvant therapy of patients having squamous cell
carcinoma (cancer) of the head and neck.
About Multikine
Multikine, a patented defined mixture of naturally derived cytokines, is
the first immunotherapeutic agent in a new class of drugs called "Immune SIMULATORS".
Immune SIMULATORS simulate the way our natural immune system acts in defending us
against cancer. As opposed to other immunotherapies which are designed to target
a single or limited number of specific antigens or molecules, Immune SIMULATORS
are multi-targeted; they simultaneously cause a direct and targeted killing of the
specific tumor cells and they activate the immune system to produce a stronger anti-tumor
attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as a
first-line standard of care treatment for cancer. It is administered prior to any
other cancer therapy because that is the period when the anti-tumor immune response
can still be fully activated. Once the patient has advanced disease, or had surgery
or has received radiation and/or chemotherapy, the immune system is severely weakened
and is less able to mount an effective anti-tumor immune response. Other immunotherapies
are administered after the patient has received surgery, chemotherapy and/or radiation
therapy, which can limit their effectiveness.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses.
Its lead product Multikine is being readied for a global Phase III trial in advanced
primary head and neck cancer. CEL-SCI is also developing an immunotherapy to treat
H1N1 hospitalized patients using its L.E.A.P.S.(TM) technology platform.  This investigational
treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1),
and the Spanish Flu as CEL-SCI scientists are very concerned about the creation
of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu,
or maybe Spanish Flu.  This investigational treatment is currently being tested
in a clinical study at Johns Hopkins University.  The Company has operations in
Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
When used in this report, the words "intends," "believes," "anticipated"
and "expects" and similar expressions are intended to identify forward-looking statements.
Such statements are subject to risks and uncertainties which could cause actual
results to differ materially from those projected. Factors that could cause or contribute
to such differences include, an inability to duplicate the clinical results demonstrated
in clinical studies, timely development of any potential products that can be shown
to be safe and effective, receiving necessary regulatory approvals, difficulties
in manufacturing any of the Company's potential products, inability to raise the
necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's
SEC filings, including but not limited to its report on Form 10- K/A for the year
ended September 30, 2008. The Company undertakes no obligation to publicly release
the result of any revision to these forward-looking statements which may be made
to reflect the events or circumstances after the date hereof or to reflect the occurrence
of unanticipated events.
SOURCE  CEL-SCI Corporation

葉芬

CVM 再接再厲。。。。。。。。

韦一笑

CVM 再接再厲。。。。。。。。
葉芬 发表于 12-1-2010 10:10 AM

    加油。。

葉芬

加油。。
韦一笑 发表于 12-1-2010 11:47 PM

CVM 需要一個 強 的消息，才能帶動她上高高。。。

希望那消息來著啦。。。。。。。。。

雨若情

CVM 需要一個 強 的消息，才能帶動她上高高。。。

希望那消息來著啦。。。。。。。。。
葉芬 发表于 13-1-2010 09:22 AM

    唉~~我都等到搬好家了。。。

m.i.k.e

Tom Watkins, Human Genome Sciences (HGSI) CEO, just appeared on CNBC to talk about Benlysta and his company's prospects in 2010.

http://myprops.org/content/Video-Human-Genome-Sciences-CEO/

葉芬

Tom Watkins, Human Genome Sciences (HGSI) CEO, just appeared on CNBC to talk about Benlysta and his  ...
m.i.k.e 发表于 14-1-2010 09:05 AM

IMMU和她是兄弟，今晚有Conference。。。

Jan 14, 2010
JPMorgan Healthcare Conference- 4:30PM EST

希望有機會偷雞。。

葉芬

轉帖： 希望今晚CVM 步步高升 。。。


Based on the 10-k here is the summary.

It's a lot of pages, but I did not find anything that was worrisome. In fact, everything Cel-Sci has been saying is in line with the report.

I note the following positives for your consideration:

1. $33+ million in cash and equivalents - enough to fund Phase III study of Multikene.

2. No dilution of common shares so far - although they can now issue up to 450 million shares, should they need to.

3. Validation of Baltimore facility. Ready to start Phase III trials in the summer of 2010.

4. They estimate they could charge $150,000/8-hour shift of usage of their cold fill plant to other pharmaceutical manufacturers that want to save money using their facility. Good chunk of money right there, if there is a demand for this.

5. JHU report from the study on LEAPS for H1N1 seems to be close.

6. LEAPS can potentially be effective on R.A. as well, among others.

7. As we all know, Orient and TEVA are the two major pharmas for Multikene. Byron is mentioned, but they are limited to South Africa. Byron needs to pay Cel-Sci $125,000 by 3/2010 in milestone payments. Iroquois law suit is mentioned, but nothing new. I think this is a frivolous lawsuit. They had to mention it b/c they are required to, but as most of us know, Iroquois's lawsuit seems totally baseless, IMHO.

SO, BOTTOM LINE, I am encouraged as an investor and a firm believer in Cel-Sci's technology and future potential. It'll be interesting to see what happens the rest of this week, esp. tomorrow, in light of these announcements.

For your info, AH trade ended at $1.01 today. GLTA tomorrow!!

葉芬

今晚Future。。。

YMH10.CBT        Mini Dow Jones Indus.-$5 Mar 10        10,653.00 10:36pm ET        Up 25.00  (0.24%)

葉芬

我的ANX還未放。。。

After Hours 價錢很不漂亮。。  

migo

回复 754# 葉芬


    芬姐，
         ANX我看了就睡不着，下午看好像有动静，买了13000，$0.47,现在脚都软！

葉芬

回复  葉芬


    芬姐，
         ANX我看了就睡不着，下午看好像有动静，买了13000，$0.47,现在脚都 ...
migo 发表于 14-1-2010 11:55 AM

我看一開市會是0.40左右，然後就
要不是又是要等下一個消息了。。


轉帖：

The known target dates for another possible run are as follows:

Before (and up to) the ANX-514 NDA submittal
Before (and up to) ANX-530 decision date
Before (and up to) ANX-514 decision date

We may also see a jump if there is an upgrade to buy from a credible source.

雨后的秋林

CTIC这两天很大波动...

韦一笑

CTIC这两天很大波动...
雨后的秋林 发表于 14-1-2010 11:27 PM

   
昨天走高，今天走低。。。。。

miku

ctic 等四月，cvm等summer

近来拓展生意，很少来了。88

葉芬

ctic 等四月，cvm等summer

近来拓展生意，很少来了。88
miku 发表于 14-1-2010 11:47 PM

Miku，有空常回來看看。。。
國際論壇需要你。


也祝你： 生意興隆。。。。