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Nice opening first 10 minutes!
Gl
"Supposed" reference is disingenuous.......
Odd context.
Gl
Ty for the confirmation.
Gl
Medgenics Launches First Clinical Trial in Hepatitis to Use INFRADURE Tissue Treatment
Phase I/II Study in Hepatitis C Expected to Provide Gateway to
Hepatitis B and D
MISGAV, Israel and SAN FRANCISCO (January 30, 2013) - Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announced today that the first patient has been enrolled in a Phase I/II clinical trial with the Company's INFRADURE? Biopump? for the treatment of hepatitis C. This is the first clinical trial of INFRADURE, a subcutaneous autologous skin tissue implant for the continuous production and delivery of interferon-alpha (INFa) being developed by Medgenics to treat hepatitis B, C and D, aimed at replacing months of weekly injections of INFa, along with their serious side effects.
The Phase I/II dose-escalation study is being initiated at the Tel Aviv Sourasky Medical Center in Israel, with additional sites in Israel expected to join the study. The study is enrolling patients with hepatitis C of genotypes 2 and 3, who would normally receive weekly injections of pegylated INFa together with a daily dose of the oral antiviral drug ribavirin These patients will receive a single implantation of INFRADURE Biopumps in place of the weekly injections, together with daily ribavirin. The study is designed to show safety and tolerability of INFRADURE through the continuous delivery of INFa into the patient's circulation and to determine effective dose levels that suppress serum levels of hepatitis C virus. Medgenics believes that the results of this study will assist in developing and calibrating INFRADURE for use in additional types of viral hepatitis, as well as other indications.
INFRADURE is aimed at replacing injections of INFa to address a global market of over 500 million patients suffering from various forms of hepatitis. This proof of concept study will test INFRADURE's approach of continuous production of INFa from the patient's own dermal tissue. The INFRADURE treatment will be similar whether used in hepatitis C, hepatitis B, the most widespread form of hepatitis, or hepatitis D, a rare and highly aggressive form of the viral disease.
The current standard of care for treating hepatitis C involves weekly injections of pegylated INFa plus daily ribavirin. These weekly injections can be associated with high concentrations or spikes of INFa in patients, as well as significant side effects. These side effects pose considerable problems with patient compliance, as reflected in a therapy discontinuation rate of over 25%. INFa injections are also the primary treatment for hepatitis D and are often used in hepatitis B, where they pose similar problems. INFRADURE aims to address compliance and tolerability by providing sustained levels of INFa within the effective range for a sustained period from a single treatment, while avoiding high concentrations that are seen immediately following injections.
INFRADURE is the second product based on the Company's Biopump tissue-based platform to reach clinical trials in patients. INFRADURE employs the same approach as the Company's EPODURE? implant producing erythropoietin, which reported months of safe and sustained treatment of anemia from a single treatment in a Phase I/II study in patients with chronic kidney disease, replacing frequent erythropoietin injections.
About Hepatitis
Hepatitis is an inflammation of the liver and refers to a group of viral infections that affect that organ. The most common types are hepatitis A, hepatitis B and hepatitis C. Viral hepatitis is the leading cause of liver cancer and the most common reason for liver transplantation. Hepatitis B affects more than 350 million people worldwide and approximately 1.3 million in the U.S. Hepatitis D, an aggressive form of hepatitis, affects approximately 15-20 million people worldwide, and is estimated to afflict tens of thousands in the U.S. Hepatitis C affects an estimated 180 million people worldwide and over 3 million in the U.S.
About Medgenics
Medgenics is developing and commercializing Biopump?, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own tissue for the treatment of a range of chronic diseases including anemia, hepatitis and hemophilia, among others. For more information, visit the Company's website at www.medgenics.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
Contacts:
Medgenics, Inc.
Dr. Andrew L. Pearlman, +972 4 902 8900
andrew.pearlman@medgenics.com
or
LHA
Anne Marie Fields, 212-838-3777
afields@lhai.com
@LHA_IR_PR
or
Abchurch Communications
Adam Michael/Joanne Shears/Jamie Hooper
+44 207 398 7719
jamie.hooper@abchurch-group.com
or
Nomura Code Securities (NOMAD & Joint Broker)
Jonathan Senior/Giles Balleny,
+44 207 776 1200
or
SVS Securities plc (Joint Broker)
Alex Mattey/Ian Callaway
+44 207 638 5600
# # #
To unsubscribe, click here or send an email to: ndarbinyan@lhai.com
:)
Let it play out, all who held will be happy with this one!
Gl
I agree, it may be too early.......
But that's ok......
Gl
Lol, it's a decent program.
But not practical with biotechs where value is not measured in numbers but valued in potential....and practicality.
Gl
Vectorvest is computer driven module that has a poor track record with biotech plays. It's fundamentally geared for S&P 500 plays.
There valuation is very cut and dry, I believe it valued Dendreon at .50 , prior to the run-up .
I could name several others......
Gl
Ty for your deliberate posts!
Cheers
All well and good......
Trade and invest in the science.
Everything else will fall in place thereafter!
Gl
Did I say it wasn't a sexy stock.....lol
Absolutely ruthless play.
Gl
Agree, nonsense
No truth to it.....if it was truth it would have been insider info.
Gl
Personally-----> yes
Logically/investor------>no
Gl
Nice pr, it only validates what we know.
Therefore, nothing new.
Already cooked in the pps.
This just strengthens, the current foundation.
Gl
Not quite, but it's good news.
Gl
Phase 3 data on the safety and efficacy of OMONTYS® (peginesatide) Injection were published in the January 24th issue the New England Journal of Medicine (NEJM).
gl
great dividend buy and solid 3 months!
gl
Looking for support, for re-entry!
She has impressed.
This quarter numbers should send a trend either way!
Gl
absolutely nothing in the long term.
it was generic excerpt from a 42 page filing thats seen in every 8-k.
look for support and entry....!
The number of shares of our common stock that will be outstanding immediately after this offering is based on 12,307,808 shares of common stock outstanding as of December 31, 2012, and excludes:
1,059,542 shares of our common stock issuable upon the exercise of stock options outstanding under our Stock Incentive Plan as of December 31, 2012, at a weighted-average exercise price of $5.17 per share, 914,219 of which were exercisable as of that date;
900,000 shares of our common stock issuable upon the exercise of stock options granted to our Chairman of the Board outside of our Stock Incentive Plan, having an exercise price of $10.80 per share, 300,000 of which were exercisable as of that date;
929,152 shares of our common stock reserved for issuance under our Stock Incentive Plan as of December 31, 2012; 5,969,891 shares of our common stock issuable upon the exercise of outstanding warrants as of December 31, 2012, at a weighted-average exercise price of $5.93 per share, all of which were exercisable as of that date; and shares of our common stock issuable upon exercise of the Series 2013-A warrants to be issued in this offering.
Except as otherwise indicated, all information in this prospectus supplement assumes no exercise by the underwriters of their option to purchase additional shares and/or Series 2013-A warrants to cover over-allotments, if any.
gl
Lol
Cheers!
Long deserved one!
Hope your well!
Ty for the update
Gl
hibernation, but not "from the dead"
this will be a jewel.
gl
Yes, but removed my basis.....
Gl
Dow is down, and HUN is up.....go figure!
gl
Could be a mute point.
Decent article.....(your thoughts)
http://m.theinquirer.net/inquirer/opinion/2184604/seagate-western-digital-wait-click-death
Gl
Not a sexy stock, but fundamentally sound in all aspects.
Gl
You bet!
:)
IMUC
08:02 AM ImmunoCellular Therapeutics (IMUC) provides an update about the various cancer vaccines it's developing, saying it expects the Data Safety Monitoring Committee to conduct an interim safety and futility analysis of the Phase IIb trial of ICT-107, which targets glioblastoma antigens and cancer stem cells, early this year. (PR)
I have always been amazed how psychology of antagonism evolves. Especially, when they can't attack the science......:)
The twisting of things old and praying that it sticks, if not keep twisting till you snap....:)
Ctix will evolve on its own, and will succeed based on its science regardless of the few.
Gl
Ditto!
Purisol will give us $5 to $8 a share, and kevetrin (gamble) can be priceless.
Gl
Ironically was about to post something about p53 from a different web page....
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2822448/
Same article.........
Gl
I trade with 3 to 6 month outlooks...out of that group I hold onto a few for long term investments.
Imuc will hopefully be one of those (ie AFFY and ECYTE to name few.)
Gl
Awfully thin trading.......
Gl
Ty for the post.
Should be a great year, an was a no brainer at $5, or $20
Gl
Reasonable target December 2013
$15 is a reasonable target December 2014.
Gl
I agree .
It's a quality company where Wall Street is investing in the corporate leadership, rather than the sales ratio.
Bubble or not, value is within the beholder and there entry.
Great long term investment that's at it's peak......(JMHO)
Gl
Strong close....my break 20 this coming week.
Congrats to those still playing this into the current highs!
Gl
Well written synopsis!
Ty for sharing!
Gl
Negative or not, the quality was poor and one of the worst written articles in recent times
Redundant, and structured around mediocre talking points.
Gl
MD Anderson?
(The number 1 cancer-research institution ?)
This is getting interesting if this is the case......
Again, I'm here for Purisol......:)
Gl