Money never sleeps pal. I just made $800,000 in Hong Kong gold. It's been wired to you -- play with it. You done good, but you gotta keep doing good.
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Winks your in the rear of the pack already... Saving Fuel are you?
11- 18 -48
I think you should Buy the Symbol...
Strategic Management & Opportunity Corp. (SMPP)Up 200% today with more to come!!
Running Nice today!!!!
Looks Great here today!! Glad I am on the Green Side!!!
I was thinking March/April we would see a Light of Hope for this one..
Niche Opportunity May Be Slipping From Protalix's Grasp
Share Call Protalix BioTherapeutics’ (PLX) Uplyso the poster child of biotech missed opportunities. With Genzyme (GENZ) struggling to meet demand for competing Gaucher disease therapy Cerezyme, and Shire (SHPGY) still trying to fill that space with Vpriv, the FDA’s complete response letter must be all the more bitter for the competitive opening that is gradually getting smaller for the Israeli company’s product (Event - Uplyso hopes to hear starting pistol, January 27, 2011).
The regulator questioned the chemistry, manufacturing and controls for the novel plant-based production process for Uplyso and requested more data from ongoing trials. It did not, however, request new trials for the treatment also known as taliglucerase alfa, which Protalix executives took as good news. But with analysts now assuming approval is at least a year away, investors deserted its shares on Friday, sending them down more than 18% to a six-month low of $7.63.
Protalix will now be in a race to get taliglucerase to market before Cerezyme resumes full production. No doubt Genzyme’s investors would like to collect the first $1-per-share bonus they would earn as part of the Sanofi-Aventis (SNY) acquisition, so there is likely some pressure for manufacturing chiefs to hit that milestone by the end of 2011 (Sanofi finally snags Genzyme with clever CVRs, February 17, 2011).
Meanwhile, Shire’s investors appear pleased, pushing shares in the British company up 4% as an immediate competitive threat was removed.
Manufacturing questions
It is not the first time that the manufacturing process for the enzyme replacement therapy has led to delays for taligucerase (Protalix's woes continue with Uplyso setback, February 2, 2010). Unlike its potential competitors, made in human and animal cells, taliglucerase is made in plant cells, specifically carrots, which Protalix argues is more cost-effective and limits the risk of mammalian viral infection. However this novelty has also brought on some scrutiny from the FDA.
In a call with investors, Protalix chief executive David Aviezer said company executives will not know all of the details of the FDA request until they can meet with agency staff. However, Mr Aviezer described the manufacturing issues as “straightforward” such as tightening specifications.
As for clinical data, the regulator would like to see data from an ongoing trial of patients who changed therapy from Cerezyme to taliglucersase and long-term safety extension, which were not complete at the time Protalix filed its new drug application. However, Mr Aviezier put a good light on the rejection by describing it, as is often the case when biotechs receive complete response letters, as another step toward eventual approval.
Investor reaction
Investors saw it a little differently. The market losses on Friday continued in early trade Monday – down another 7% to a six-moth low of $7.12 (Protalix can wait for Uplyso's FDA review, July 13, 2010).
As taliglucerase is Protalix’s only project that has any value ascribed to it, with a net present value of $904m, according to EvaluatePharma data – one and a half times the company’s market capitalization at Friday’s close – this behavior is not surprising.
For partner Pfizer (PFE), which holds rights to the biologic outside of Israel, the news had no effect (Protalix brings on Pfizer as fight for Gaucher patients looms, December 2, 2009). Analysts for the New York giant have not ascribed any value to taliglucerase yet, quite possibly because of the risk of these regulatory delays as well as questions over commercial potential.
Orphan opportunity
As an orphan condition, Gaucher disease may not have the multi-blockbuster potential of a cancer or cardiovascular treatment and may not be able to get the attention of Pfizer watchers until it is nearly on the market. Still, those high-profit orphan conditions are seen as attractive targets for big pharma looking to fill empty pipelines (Glaxo attracted to rare diseases, October 13, 2010).
Gaucher disease affects 1 in 20,000 live births, although in certain populations, such as Eastern European Jews, the incidence is much higher. Genzyme’s experience has shown that such “nichebuster” indications can be very lucrative, with annual costs exceeding $100,000 a year.
That is an opportunity that has slipped from Protalix’s and Pfizer’s grasp once again. An FDA approval would have given taliglucerase a chance to exploit Cerezyme’s market weakness. Now it appears it will be attacking a Gaucher space next year that has two stronger incumbents.
48, 11, 99 Next Race!!
Line them up!
Protalix to Present New Data on taliglucerase alfa and Preclinical Data on Oral Enzyme glucocerebrosidase at the WORLD Lysosomal
Protalix Biotherapeutics Common Stock (AMEX:PLX)
Historical Stock Chart
1 Month : January 2011 to February 2011
Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), announced today that new clinical data from the switchover trial of taliglucerase alfa in Gaucher disease patients and preclinical data on oral enzyme glucocerebrosidase (oral GCD) will be presented today at the 7th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2011 in Las Vegas, Nevada. Both drug candidates are unique in that they are produced through the Company's proprietary plant-cell protein expression system.
Switchover Trial of taliglucerase alfa
Gregory Pastores, M.D., Associate Professor of Neurology and Pediatrics and Director of the Neurogenetics Laboratory at New York University School of Medicine and a study investigator, will present new data from the Company's switchover trial during an oral session titled: "Plant Cell Expressed Recombinant Glucocerebrosidase taliglucerase alfa as Therapy for Gaucher Disease in Patients Previously Treated with Imiglucerase."
"Interim results from the switchover trial support the safety and maintenance of efficacy of taliglucerase alfa in patients with Gaucher disease who were previously on imiglucerase," said Dr. Gregory Pastores.
The switchover trial is a phase III multicenter, open-label clinical trial designed to assess the safety and efficacy of taliglucerase alfa in Gaucher disease patients who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy. Patients eligible for the switchover trial are evaluated for 12 weeks to establish the stability of their disease. Patients with confirmed stable disease are switched from imiglucerase (doses ranging from 10-60 U/kg every other week) to an equivalent dose of taliglucerase alfa using the same number of units for a nine-month period. Adult enrollment in the study has been completed (n=25); pediatric enrollment remains open. The trial is being conducted in 10 centers throughout North America, Europe, Israel and Australia.
Dr. Pastores will present clinical trial data from an interim report completed in August 2010 which includes efficacy data from 15 patients and safety data from 25 patients. The data indicate that patients can safely be switched to taliglucerase alfa from imiglucerase.
The efficacy analysis from the interim report (n=15) demonstrates that, on average, hemoglobin and platelet count, spleen volume and liver volume all remained stable over the nine-month period, and no patients showed a sustained clinical deterioration.
The safety analysis from the interim report (n=25, as performed at the time of data lock) demonstrates that taliglucerase alfa was well tolerated and no drug related severe adverse events were reported. No patients experienced hypersensitivity reactions, one patient developed antibodies to taliglucerase alfa and no patients developed neutralizing antibodies. Most adverse events were considered unrelated to taliglucerase alfa. The most frequent mild to moderate adverse event was nasopharyngitis, a viral infection of the upper respiratory system.
The Company and Pfizer Inc. have filed a new drug application (NDA) or a marketing authorization application (MAA), as applicable, for taliglucerase alfa in the United States, European Union, Brazil and Israel. The Company received a Prescription Drug User Fee Act (PDUFA) date of February 25, 2011 from the U.S. Food and Drug Administration for the taliglucerase alfa NDA.
Oral Enzyme glucocerebrosidase
Yoseph Shaaltiel, Ph.D., the Company's Executive Vice President, Research and Development, will present preclinical data on the Company's oral enzyme glucocerebrosidase (oral GCD) during an oral session titled: "Oral Delivery of Recombinant Glucocerebrosidase Enzyme Naturally Encapsulated in Carrot Cells." Oral GCD is a plant cell expressed form of GCD that is naturally encapsulated within carrot cells genetically engineered to express the GCD enzyme.
Preclinical studies of oral GCD demonstrate the stability of the enzyme in the cell and the capacity of the cell's cellulose wall to protect the enzyme against degradation in the digestive tract in an in-vitro model of the stomach and intestines. Additionally, rats fed lyophilized carrot cells expressing GCD have accumulated the active enzyme in the target organs, the spleen and liver.
Oral GCD is being developed for the treatment of Gaucher disease. The Company intends to initiate phase I clinical trials in carriers of Gaucher disease who show reduced enzymatic activity at baseline.
About Protalix
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system, ProCellEx™. Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner in an environment free of mammalian components and viruses. Protalix's lead compound, taliglucerase alfa, an enzyme replacement therapy for the treatment of Gaucher disease, completed phase III clinical development. Regulatory applications have been submitted for taliglucerase alfa in the United States, the European Union, Brazil and Israel. Taliglucerase alfa is available to patients with Gaucher disease in the United States under an Expanded Access protocol, in Brazil under a supply agreement, in France under an ATU program, as well as to patients in several member states of the European Union, Israel and other countries under Named Patient provisions.
Protalix's development pipeline also includes: PRX-105, a pegylated recombinant human acetylcholinesterase in development for several therapeutic and prophylactic indications, a biodefense program and an organophosphate-based pesticide treatment program; PRX-102, a modified version of the recombinant human alpha-GAL-A protein, for the treatment of Fabry disease; an orally-delivered glucocerebrosidase enzyme that is naturally encased in carrot cells, also for the treatment of Gaucher disease; and pr-antiTNF, a biosimilar version of etanercept (Enbrel™), for the treatment of rheumatoid arthritis.
Safe Harbor Statement
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause material differences include, among others, risks relating to: the successful preclinical development of our product candidates; the completion of our clinical trials; the review process of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), other foreign regulatory bodies and other governmental regulatory bodies, including the risk that regulatory authorities may find that the data from our clinical trials and other studies is insufficient for regulatory approval; delays in the FDA's, the EMEA's or other health regulatory authorities' approval of any applications we file or refusals to approve such filings, including the new drug application (NDA) and the marketing authorization applications (MAAs) we filed with the FDA, the EMEA and other health regulatory authorities for taliglucerase alfa for the treatment of Gaucher disease; refusals by such regulatory authorities to approve the marketing and sale of a drug product even after acceptance of an application we file or submit for any such drug product; the identification of lead compounds; the risk that we may fail to satisfy certain conditions relating to grants we have received from the Office of the Chief Scientist of Israel's Ministry of Industry and Trade which may lead to our being required to refund grants previously received together with interest and penalties; and other factors described in our filings with the Securities and Exchange Commission. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced or late-stage clinical trials, even after obtaining promising earlier trial results or in preliminary findings for such clinical trials. Further, even if favorable testing data is generated from clinical trials of drug products, the FDA, EMEA or any other foreign regulatory authority may not accept or approve an NDA filed or MAA submitted by a pharmaceutical or biotechnology company for such drug product. Failure to obtain approval from the FDA, EMEA or any other foreign regulatory authority of any of our drug candidates in a timely manner, if at all, will severely undermine our business and results of operations by reducing our potential marketable products and our ability to generate corresponding product revenues. The statements in this release are valid only as of the date hereof and we disclaim any obligation to update this information.
Investor Contact
Marcy Nanus
The Trout Group, LLC
Telephone: 646-378-2927
Email: mnanus@troutgroup.com
SOURCE Protalix BioTherapeutics, Inc.
Im Ready for the Green!!!!
Running Hot winks!! Its over 80 outside here today.... TURN IT UP!!!
Lets see if they get the FDA Approvel Today here or in the Morning..
Takes a couple days due to the Symbol change..
Be interesting to see how this one closes out the week!!
Robert F.X. Sillerman Recapitalizes Gateway Industries, Inc.
Robert F.X. Sillerman, media entrepreneur, announced today that he has completed the recapitalization of Gateway Industries, Inc. (GWAY.PK), effective February 11, 2011. Following the reverse 1 for 10 stock split which became effective on February 16, 2011, 120,000,000 shares were acquired by Mr. Sillerman, affiliates and investors approved by him at $0.03 per share. As part of the recapitalization, the Company changed its name to Function (X) Inc. and its stock symbol to FNCX. Immediately after the recapitalization, Function (X) raised an additional $10.5 million through the issuance of 940,000 shares at approximately $0.53 per share and 13,232,597 at approximately $0.76 per share.
Mr. Sillerman has made his investment in the Company to establish a new platform for investments in media and entertainment, with a particular emphasis on digital and mobile technology. Mr. Sillerman is evaluating several initiatives aimed at combining certain established business principles with a new element enabled by digital and mobile distribution capabilities. An initial product under consideration would emphasize Smartphone application, with a goal of being ready for Beta testing in the 3rd quarter of 2011. The Company is not disclosing any details about this product for competitive reasons, and because this product has not reached the stage of a specific plan for its commercial adaptation.
For further details regarding the recapitalization transaction and the risks associated with any investment in the Company, please see the Company’s Current Report on Form 8-K to be filed with the Securities and Exchange Commission on February 16, 2011.
Nice Play here today!!
THEY CALL ME FRONTRUNNER!!!!!
MY PICKS ARE IN... 48-11-88
Been 10 years winks!!
Its going to be a fun Spring Here.. I think we have seen the Bottom here..
Good weekend for the shoot out!! Lets RACE!!!
Where is the Bounce? She shot up like a Rocket!!
I hear ya! But were going the WRONG WAY!
Rubbing is Racing Winks!! Just watch the Wall !!!!!!!!
Great Gains here today Folks.. Keep them Coming!!
Stay Safe Winks!
This stock seems to Pump in the fall. 2 years Straight I turned 80% on this in Late Oct/Nov... I'll be back then for More Walmart Stories!!
Tuff Cookie to crumble...
Winks the Florida Market is a steal right now. We picked up a Waterfront condo for .25 on the dollar. Houses are in shortsale for 1/4th the price they were 3 years ago...
Penny land is not for me anymore winks! Ebay. GE. GM. IBM. GOOG
Oh Doggs!! Who Pulled the plug on this one??
Were leaving for Naples on monday... Last Chance winks to Catch those lakers Vs Knicks on Friday!
Ya. Time to get out of this winter spell and move to $2 for us...
THANK YOU! I HAD TO BUY SNOWMOBILES AGAIN THIS YEAR JUST TO PASS TIME!!
FAST SKI_DOO'S!
I got the same thing today Hand written not with my name. PUMP IT UP!!
Where do I sign up? After this long cold winter I need to head south!!
I WANNA WIN AND JOIN WITH YOU GUYS!!!!!!!!!!!!!!!!!!!!!!!!!
Current report filing (8-K)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 1, 2011
CYCLACEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-50626 91-1707622
(State or other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.)
200 Connell Drive, Suite 1500
Berkeley Heights, NJ
07922
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (908) 517-7330
(Former name or former address if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
1
--------------------------------------------------------------------------------
Item 8.01 Other Events.
On February 1, 2011, Cyclacel Pharmaceuticals, Inc. (the “ Company ”) paid a quarterly cash dividend in the amount of $0.15 per share on the Company’s 6% Convertible Exchangeable Preferred Stock (“ Preferred Stock ”). The dividend is payable to the holders of record of the Preferred Stock as of the close business on January 21, 2011.
The Board considered numerous factors in determining whether to declare the quarterly dividend, including the requisite financial analysis and determination of a surplus. While the Board will analyze the advisability of the declaration of dividends in future quarters, there is no assurance that future quarterly dividends will be declared.
2
Hey Boss.. Nice to see some Green for once..
This one is sinking fast!!!!