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  • Expecting Post-Stimulus Catalyst for Stem Cell Research Companies [View article]
    Please visit my website and let me know if you would like to contribute articles such as your reply below. Mike@BioMedReports.com


    On Apr 02 12:02 AM quiact wrote:

    > Over 100 years ago, a Russian histologist suggested stem cells be
    > applied for scientific research. They are the human body’s equivalent
    > of a generator, as they can renew, regenerate, and replicate under
    > the right conditions.
    >
    > The apex of cellular therapy and regenerative/reparative medicine
    > has been reborn after an 8 year moratorium that basically halted
    > federal funding for stem cell research with most states in the U.S.
    >
    >
    > Now the NIH can award grants to scientists involved with biomedical
    > research involving stem cell therapy through the CMS to each state
    > in the U.S.
    >
    > While never banned, stem cell research had limited funding during
    > this time. And this was unfortunate, because there are several likely
    > uses of stem cells.
    >
    > These uses include the replacement of tissues in the human body,
    > as well as repairing cell types that are defective. Also, stem cells
    > can deliver genetic therapies that are needed in certain patients.
    >
    >
    > ESCs are totiplotent if obtained from the morula which is a pre-blastocyst
    > stage. Normally, the stem cells are acquired from the blastocyst
    > itself. From this source, the stem cells can be any cell in the human
    > body except for the placenta, and are pluripotent.
    >
    > Embryonic stem cells are obtained from a 4 day old embryo called
    > a blastocyst, and are pluripotent from this source. The blastocyst
    > contains about 100 cells, and is not suitable at this stage for implantation
    > into the uterine wall.
    >
    > The inner core of the blastocyst has about 20 cells, and this is
    > where stem cells are obtained.
    >
    > These cells are unspecialized cells that can be developed or morphed
    > into the over 200 cells available in the human body through differentiation,
    > as ESCs are undifferentiated by nature.
    >
    > As such, they can become any human cell, as long as they are prevented
    > from clumping or crowding together when explanted into cultures as
    > they are propagated. After stem cells are cultured, they are moved
    > to what are called stem lines.
    >
    > Until recently, ESCs were believed to be most beneficial instead
    > of the adult stem cell alternative (seekingalpha.com/symbo...),
    > as these stem cells are limited to application to the tissue the
    > stem cells were obtained from only. However ASCs (somatic stem cells)
    > now can be coerced into differentiation through plasticity (trans-differentiation).
    > This likely will reduce if not eliminate those opposed to stem cell
    > therapy because of moral and ethical reasons related to the utilization
    > of ESCs.
    >
    > Thanks to molecular biology, four transcription factors control the
    > transfer of genetic information from DNA to RNAS to regulate gene
    > expression. So ASCs can have the same beneficial qualities as ESCs.
    >
    >
    > In the past, viral vectors and exotic genes interfered with the purity
    > of ASCs. Now ASCs are re-programmed using plasmids instead of viruses
    > and oncogenes that can become detrimental for the patient treated.
    >
    >
    > So now, ASCs can safely become induced pluripotent cells with the
    > same potential as ESCs. As a result, the ASCs are free of genetic
    > artifacts that potentially can interfere with transgene sequences.
    >
    >
    > They are capable of, and are able to renew and reproduce with minimal
    > effort, stem cells, under the right laboratory conditions.
    >
    > Human blood can be reproduced with stem cells under the right conditions,
    > it has been shown by researchers.
    >
    > SCT can also be used to investigate disease states for better treatment
    > options.
    >
    > Disease-specific stem cell lines, which are those cells that are
    > pluripotent and are created with the same genetic errors of certain
    > diseases, are studied for this reason.
    >
    > So there clearly is a huge potential for stem cell-based therapies.
    > The first FDA approved clinical trial occurred early in 2009. This
    > human trial will involve evaluating primarily the safety of ESCs
    > designed to be used as treatment for spinal cord injury patients.
    > The trial was submitted by Geron Corp.
    >
    > Pfizer, the largest drug company, has implemented stem cell research,
    > as they are an asset to drug discovery by creating within the organization
    > a regenerative medicine unit. Other large pharma companies are implemented
    > similar research protocols for the same reasons.
    >
    > Geron Corp. in California is the world’s leading esc developer, and
    > financed researchers at Univ. of Wisconsin, who isolated the first
    > human esc in 1998.
    >
    > Stem cell therapy potentially can cure multiple sclerosis, among
    > other disases and those with damaged human tissue. The therapy prevents
    > the advancement of disease, as well as reverses the neurological
    > dysfunctions associated with MS. Patients are injected with their
    > own stem cells obtained from their bone marrow, which are called
    > haemopoietic stem cells.
    >
    > These particular stem cells are the origin of all blood cells. Further
    > large clinical trials are needed to support these results. Studies
    > have shown between 70 and 80 percent of MS patients who received
    > stem cell therapy did not relapse afterwards.
    >
    > Allogenic, or donor transplants, have a risk of graft versus host
    > disease. Autologous, which is the patient’s own stem cells, are preferable
    > and most beneficial. Similar results from this autologous bone marrow
    > transplant cellular therapy are seen with Chron’s disease as well.
    >
    >
    > During the procedure, the immune system is reset so it is not in
    > an autoimmune state where it attacks the human body. The process
    > lasts about 2 months, and consists of 6phases:
    >
    > 1. Initial chemo
    > 2. Release of stem cells
    > 3. Acquisition of stem cells
    > 4. Cells are then frozen until ready for transplant
    > 5. Second chemo to reduce leukocytes
    > 6. Autologous stem-cell transplant. Immune system is reset.
    >
    > Positive results from stem cell therapy are seen usually within a
    > month, and patients can request another treatment about 6 months
    > after the first treatment presently. This stem cell paradigm of therapy
    > addresses the etiology of a disease state, instead of focusing on
    > the symptoms only. As such, this is the practice of regenerative
    > medicine with the implementation of SCT.
    >
    > Some believe ethical restraints are needed regarding the use of ESCs
    > for therapeutic reasons. Yet they improve the quality of life of
    > those with devastating diseases which involves suffering without
    > any relief.
    >
    > So stem cell therapy and research may be the most right and ethical
    > thing to do for such patients. Not only is the tremedous suffering
    > relieved with those possessed with devistating diseases, their functional
    > ability is restored for those who receive stem cell therapy.
    >
    > Embryos are acquired from fertility clinics (IVFs) that have thousands
    > routinely stored and are abnormally fertilized. This means that they
    > could never go on to become a human, and would be destroyed otherwise.
    >
    >
    > Ironically, one could argue it is inappropriate to discard what may
    > be valuable and ethical for others, potentially.
    >
    > Most couples with frozen embryos would gladly give them to such research,
    > surveys have concluded.
    >
    > These embryos are believed by many to not be morally equivalent to
    > human life, but only have the potential for life. And they are used
    > for therapeutic cloning, known as somatic cell nuclear transfer,
    > and not reproductive cloning.
    >
    > Ten states have banned this cloning out of ignorance, it seems. Bioethic
    > principles, which are beneficience, or physician-centered decisions,
    > as well as non-maleficence, which is first do no harm, are not corrupted.
    >
    >
    > Furthermore, autonomy, which is the patient’s right to determine
    > their health, and justice or fairness remain intact.
    >
    > Stem cells should be utilized for those terminally ill as well, many
    > believe. Many are seeking stem cell therapy overseas due to retrictions
    > that exist in the U.S. presently. The United Kingdom is believed
    > to be the leader in stem cell research p
    >
    Apr 5 08:19 AM | Likes Like |Link to Comment
  • Cytori Therapeutics: Natural Play on Cosmetic Medicine [View article]
    thanks for the continuous KOOL public service announcements!
    Mar 19 04:21 PM | Likes Like |Link to Comment
  • Javelin Pharma's Late-Stage Pipeline Pain [View article]
    My title read: Javelin Pharma: Late-Stage Pipeline Targets Pain

    biomedreports.com/arti...

    I do not work for Seeking Alpha as an editor or control what they publish! Obviously, I am bullish on JAV.


    On Mar 19 02:20 PM beginswithz wrote:

    > What a misleading headline...it sounds as if JAV is failing in late
    > stage trials! The article seems to document just the opposite.<br/>
    >
    > Consider reprinting under a different heading or retracting this
    > article!
    Mar 19 04:19 PM | Likes Like |Link to Comment
  • Electro-Optical Sciences: Positive Results for MelaFind [View article]
    not exactly, it represents a screening tool for dermatologists and an improvement over visual screenings which had a 3.6% specificity versus 9.5% for the device. also picks up lesions below the surface


    On Mar 18 08:41 AM Jose McIntyre wrote:

    > So basically this device calls everything melanoma. That way it captures
    > 98% of melanoma correctly but also incorrectly calls non melanoma,
    > melanoma over 90% of the time. Sounds like a winner :)
    Mar 18 09:22 AM | Likes Like |Link to Comment
  • Cytori Therapeutics: 2009 Outlook [View article]
    I have written about KOOL before and lots of other companies here and on my blogs/websites:
    biomedreports.com/blog...

    So what is your purpose in posting anonymously here and on other message boards that aren't even for KOOL?

    If it turns out to be the CSCO of stem cells then you will make a lot of money so I guess you are just looking out for everyone by posting here and elsewhere.

    Cytori is already on the market in EU/Japan and will hear back from the FDA in May for Celution filing strategy.


    On Mar 16 09:22 PM User 374873 wrote:

    > Mike, don't waste your time pumping this dead horse...you sounded
    > like a hired gun to pump this stock, aren't you?
    >
    > The only stem cell related stock worth investing at this early stage
    > is the CSCO of this industry who is providing all the tools and equipments
    > to this industry -- Thermogenesis (seekingalpha.com/symbo...),
    > you know as well as many people do that KOOL is about to become profitable
    > from operation and they've got many new products out serving the
    > real need of this industry.
    >
    > All R&amp;D shops like STEM, GERN, ASTM and CYTX have no FDA approved
    > product, no revenue but tons of loss and dilution. Anyone who pumps
    > these R&amp;D shops are guilty of luring investors to lose money.
    > It's immoral if not down right guilty.
    Mar 16 11:29 PM | Likes Like |Link to Comment
  • Trading FDA Decisions: 14 Candidates [View article]
    check out this article for SVNT update:
    seekingalpha.com/artic...




    On Mar 16 02:18 PM truthiac wrote:

    > You could add the PDUFA date of August 1, 2009, for Savient Pharmaceuticals,
    > Inc.'s (seekingalpha.com/symbo...) pegloticase for treatment-failure
    > gout. Since SVNT is a one-product candidate company, a major impact
    > can be expected.
    Mar 16 04:14 PM | Likes Like |Link to Comment
  • Updates to FDA and Clinical Trial Calendars [View article]
    liraglutide is a synthetic, long-acting version of glucagon-like peptide-1 (GLP-1). GLP-1 is produced by cells located in the intestines.


    On Mar 10 07:53 PM NEH wrote:

    > What part of the body produces liraglutide. Reply if you can, and
    > I will have a look at your website. Thanks BioMedReports.com!
    Mar 10 10:21 PM | Likes Like |Link to Comment
  • Updates to FDA and Clinical Trial Calendars [View article]
    Victoza (liraglutide) is used once-daily via subcutaneous injection. Liraglutide is a synthetic glucagons-like peptide-1 (GLP-1) and is classified as an incretin mimetic type of diabetes drug. GLP-1 is a gut-derived regulator of glucose that is released after oral ingestion of carbohydrates or gats. Type 2 diabetics have reduced levels of GLP-1 in response to carbohydrate intake.

    GLP-1 enhances insulin secretion once it enters the systemic circulation and also increases the synthesis of insulin. Other effects of GLP-1 include suppression of glucagon secretion, slower gastric emptying (5-10% incidence of nausea), reduced food/caloric intake, and pancreatic beta cell proliferation. Liraglutide does not increase insulin secretion or suppress glucagons secretion when blood glucose levels are low or normal.

    Symlin (pramlintide) is used via subcutaneous injection prior to meals as a synthetic analog of the hormone amylin which is secreted by the pancreatic beta cells along with insulin in health individuals (amylin is secreted at much lower levels than insulin, e.g. 1:20 ratio). Amylin secretion is absent in Type 1 diabetics and decreased in Type 2 diabetics. Decreased or absent amylin secretion results in inadequate response to insulin treatments leading to weight gain and poor glycemic control (especially after meals or postprandial).

    Amylin replacement therapy results in slower gastric emptying (nausea side effect results), decreased appetite/caloric intake, and decreased glucagon secretion after meals. In combination with insulin, Symlin treatment results in better glycemic control and causes modest weight loss (versus weight gain associated with insulin mono-therapy).
    Mar 8 03:09 PM | Likes Like |Link to Comment
  • Vivus: A Bet on Well-Funded, Late-Stage Pipeline [View article]
    Biotechs_Maven, check out my new website at BioMedReports.com -- we are looking for contributors on the site so email me if you are interested, Mike


    On Mar 04 07:05 AM Biotechs_Maven wrote:

    > Take a look at VVUS Phase 2 trial.At that time they actually use
    > the same Generic Topiramate 100mg dose and Generic Phentermine dose
    > too.They even do not bother to mix the two drug into one tablet at
    > all.But the way they dose it was,
    > they give one drug in the morning and the other in the afternoon.
    >
    > Only from Phase 3 that they change the formulation slightly, that
    > because They need to make it different then the Generic formulation.
    >
    > That show if the Phase 2 trial is doing just fine with generic dose,
    > then most people will buy the generic Topiramate and Phentermine
    > dose and use it just like the way VVUS use it in their Phase 2 trial.
    >
    >
    > also Topiramate had received FDA warning on 2001, that it might cause
    > adverse event to the eye, and just few months ago, receive another
    > FDA warning that Topiramate could cause 1 out of 500 patients with
    > Suicide thought.
    >
    > This same Suicide thought was the one that make Acomplia (another
    > diet drug) do not get approved by FDA, and later Acomplia even get
    > pulled back from European market where it were already approved.
    >
    >
    > Plus the fact that from Qnexa Diabetic 1 year trial, it is shown
    > that Qnexa start to loss efficacy after only 28weeks of use, and
    > then at week 44, the arm taking Qnexa actually start to GAIN Weight
    > instead.
    >
    > The Insider also had been selling lot of shares lately, in fact the
    > CEO of VVUS is selling his shares the same day as VVUS R&amp;D day.
    > So during that day while VVUS is presenting the result of Qnexa Phase
    > 3 Equate trial, VVUS CEO is selling his shares,
    > and had been selling more then $2.5million worth of VVUS shares for
    > the last 18months.
    > and the insider that is selling is not limited to only VVUS CEO but
    > many other insider also sell.
    >
    > There is no doubt that Qnexa have decent efficacy, but efficacy alone
    > is not enough to guarantee approval of Qnexa.
    >
    > VVUS share price also had been trending down this past few months
    > after the result of Equate phase 3 study (a short 6months study with
    > not large patients involved).
    >
    > so maybe VVUS is a good short term play, but before you decide your
    > self for long term hold on VVUS, you got to do more due dilligence
    > on the data itself.
    >
    > My bet is on ARNA instead, because ARNA is brand new drug (not generic
    > combo), and management of ARNA mostly buying shares or holding to
    > ARNA shares, (very dismal selling).
    > ARNA also had enough money to last until NDA on early 2010,
    > and the CEO of ARNA even decide to pay up the convertible holder
    > with CASH instead of diluting shareholder by paying with shares.That
    > show ARNA is very confident with the result of Lorcaserin.ARNA also
    > enrolled more then 7100 patients in their Two Phase 3 trial, far
    > larger then VVUS or OREX Phase 3 study.
    > and their First Phase 3 trial is a 2 year trial, so this should satisfy
    > the FDA about Lorcaserin long term use.
    >
    > Disclosure: I holds a LONG positions in ARNA
    Mar 4 07:41 AM | 1 Like Like |Link to Comment
  • New Index of Highly Defensive Market Cap Leaders [View article]
    All of the ETF Innovators indexes are featured at my new site and will be tracked at the site in the future, but not initially -- none of the indexes have tickers or associated ETFs/funds yet:
    www.biomedreports.com/...
    Feb 28 09:38 AM | Likes Like |Link to Comment
  • New Index of Highly Defensive Market Cap Leaders [View article]
    Started last year on 2/1/08
    Quarterly Rebalancing
    Exchanges within one week of mergers
    Will be tracked on daily closing basis at my new website once the web programmer adds this feature, for now the component stocks are listed:
    www.biomedreports.com/...



    On Feb 26 06:05 PM Anonymous 2 wrote:

    > Interesting - but many questions - a few for starters:
    > on what day/date did this index start?
    > how often would such a portfolio be reallocated to maintain the equal
    > weightings?
    > "who" (at ETF Innovators ?) and how often would exchanges to take
    > place going forward to allow for mergers?
    Feb 26 06:27 PM | 1 Like Like |Link to Comment
  • FDA Decisions and Clinical Trials: An Updated Calendar [View article]
    www.etfinnovators.com/...


    On Feb 06 09:17 AM ArchDukeFerdinand wrote:

    > You left out Arena Pharmaceuticals (seekingalpha.com/symbo...).
    > They are suppose to get a FDA decision on their obesity drug lorcaserin
    > in late March of this year.
    Feb 6 09:21 AM | Likes Like |Link to Comment
  • Stem Cell and Regenerative Medicine Stocks Surge in December [View article]
    ThermoGenesis: A Stealth Stem Cell Play
    Posted on 1/31/09 at my blog:

    www.etfinnovators.com/...
    Feb 1 10:49 AM | Likes Like |Link to Comment
  • Stem Cell Research Stocks Soar as Obama Takes Office [View article]
    Cytori Therapeutics (CYTX) has been soaring ever since the Geron news and their products are already on the market in Europe and Asia for reconstructive medicine and cell banking plus they process adult stem cells from the patient's own fat tissue via the Celution System
    Jan 27 12:53 PM | Likes Like |Link to Comment
  • FDA Calendar: Cardiome, Momenta, Discovery Labs, Introgen [View article]
    This is a website for investors and traders who are interested in business news -- so why are you even here as your stupid comments offer nothing of value!

    Why don't you spend your time chastising people like Bernie Madoff and others on Wall Street who scammed people of billions!


    On Jan 26 05:14 PM natoya pearson wrote:

    > Its a shame how you would let the fda approve your drugs cardiome
    > pharma when you know that you are just killing people. I know the
    > fda approves drugs that will only make your worse not better. The
    > game is all about money thats why the drugs companies are rich and
    > the fda is getting richer. All you and the fda care about is money
    > not the people on this earth and you will be judged by the highest
    > of them all one day and i hope he has mercy on your souls. If money
    > is all you care about just know this............. money is the route
    > of all evil.
    Jan 26 06:22 PM | Likes Like |Link to Comment
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