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$OXGN - OXiGENE Receives Guidance From FDA Supporting Phase 3 Trial Of Fosbretabulin/Bevacizumab Combination In Platinum-Resistant Ovarian Cancer
SOUTH SAN FRANCISCO, Calif., June 1, 2015 (GLOBE NEWSWIRE) -- OXiGENE, Inc.(OXGN) , a biopharmaceutical company developing novel therapies for the treatment of cancer, today provided an update on recent discussions with the U.S. Food and Drug Administration (FDA) regarding the design of a proposed Phase 3 trial of fosbretabulin in combination with bevacizumab in patients with platinum-resistant ovarian cancer.
FDA agreed with the company's proposal to test the combination anti-vascular regimen of fosbretabulin and bevacizumab directly against chemotherapy using progression-free survival (PFS) as the primary endpoint in a randomized, controlled registration trial.
FDA requested inclusion of a third arm, of bevacizumab alone, in the trial to further characterize the efficacy of each individual drug in the combination.
OXiGENE (OXGN) intends to submit an application to the FDA for a Special Protocol Assessment (SPA) later this year.
"We are extremely pleased by the agency's support for advancing to a Phase 3 trial and their guidance in defining a registration pathway for fosbretabulin in platinum-resistant ovarian cancer," said Bill Schwieterman, M.D., OXiGENE's(OXGN) President and CEO. "Patients with this advanced form of ovarian cancer have limited treatment options, and there are no currently approved treatment regimens that avoid the adverse effects associated with standard chemotherapy. We believe that an anti-vascular regimen could offer a new paradigm of treatment and an important addition to the available therapies for advanced ovarian cancer. Our strategy is now to prepare a full protocol for a three-arm Phase 3 trial and to pursue a SPA while we simultaneously explore funding and partnering opportunities for this promising program."
The proposed Phase 3 trial is based on the results of the GOG186I study in which the anti-vascular combination of fosbretabulin and bevacizumab showed statistically significant improvements in PFS compared to bevacizumab alone as defined by the statistical analysis plan. The benefits appeared to be particularly robust in a subset of patients with platinum-resistant disease where a post-hoc subgroup analysis of the study showed that patients who were platinum-resistant had a median PFS of 6.7 months when treated with bevacizumab and fosbretabulin compared to 3.4 months for those receiving bevacizumab alone.
In the U.S., approximately 22,000 women are diagnosed with ovarian cancer each year, of which 4,300 are resistant to platinum-based therapies. Many patients who are platinum-resistant have already experienced multiple cycles of conventional chemotherapy, and suffer from significant side effects. As the first potential non-chemotherapeutic regimen for platinum-resistant ovarian cancer, OXiGENE(OXGN) believes the combination of fosbretabulin and bevacizumab has the potential to avoid the side effects of standard chemotherapy and provide a more convenient dosing regimen.
About OXiGENE(OXGN)
OXiGENE (OXGN) is a clinical-stage biopharmaceutical company developing novel therapies for treatment of cancer. The company is focused on developing vascular disrupting agents (VDAs), which are compounds that selectively disrupt abnormal blood vessels associated with tumor survival and progression. The company's lead clinical product candidate, fosbretabulin, is in development as a potential treatment for solid tumors. OXi4503, its second product candidate, is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
$OXGN might be an interesting day today.
OXiGENE Gets U.S. Patent for Myeloid Neoplasms Treatment - Jumping 7% in After-Hours
BY Midnight Trader
— 4:10 PM ET 05/26/2015
$OXGN I'm thinking about the same, ~$6. IMO
OXiGENE Gets U.S. Patent for Myeloid Neoplasms Treatment - Jumping 7% in After-Hours
BY Midnight Trader
— 4:10 PM ET 05/26/2015
$OXGN looking good here
$OXGN moved rapidly yesterday afternoon, up ~12% at close. A little pullback this morning but appears to be moving back up. Currently $1.44, target $6. IMO
$OXGN moved rapidly yesterday afternoon, up ~12% at close. A little pullback this morning but appears to be moving back up. Currently $1.44, target $6. IMO
Most welcome $OXGN
$OXGN nice volume this AM. After some profit taking going on, expecting to see it move rapidly as it thins out. IMO
Think so too. Here's one of the articles that may be of interest:
http://www.benzinga.com/analyst-ratings/analyst-color/15/04/5379567/h-c-wainwright-co-retains-positive-outlook-on-oxigene
I bought about 800 shares myself between 1.38-1.40. Loved the action today, no idea why it's jumped like it did. My guess is that it has something to do with positive results on the trials/studies that are pending. Hoping for some great news soon. I read one article last week stating they had a $6 target within a year. Not sure about that, stocks like this can move much higher/lower depending the right news. Just have to wait an see.
After what Berge has done to many of us, I wouldn't send my worst enemy here. I still can't get over how foolish I was to believe in this guy. I thought he was truly interested in becoming successful. I was wrong.
Didn't see this in the iHub News feed so posting it...
iTalk Inc. Names Energy and Telecommunication Expert Trip Camper as Limestone's New President
MARKET WIRE 7:00 AM ET 1/8/2015
FT LAUDERDALE, FL -- (Marketwired) -- 01/08/15 -- iTalk, Inc. (OTCQB: TALK) today announced is pleased to announce that the company has appointed Mr. Trip Camper as the President of Limestone Energy Holdings Inc., its newly formed energy subsidiary.
Trip is a business leader that brings over 30 years of Executive Management experience in banking, energy, financial services, and telecommunication companies. His businesses have raised substantial amounts of capital, while leading the creation of initial and secondary public offerings, venture capital, joint venture and private equity financing. He has been the Managing Partner of Oil and Gas properties in Texas including Hilliard Bender Energy and Coyanosa Resources. He is the former CEO and President of InZon Corporation, a mobile cellular services company. Mr. Camper served as its Chief Executive Officer and President of Elandia, Inc, through its initial public offering. He served on the Boards of Directors of seven Elandia subsidiaries and of the DaTec Group of companies in the Pacific Island Nations. Previously, he was the CEO and President of the Morgan-Dos Development Company, a telecommunications tower infrastructure company which sold to Mastec Corporation, a NYSE company, where he joined the Executive Management Team. Mr. Camper was also a partner in TowerCom, a company that builds, develops and owns cellular towers. "We are very excited to have Trip join the iTalk team and I personally look forward to working closely with him on the energy sector planned expansion and to further build shareholder value.
As part of this diversification strategy TALK has begun exploring strategic options to either partner its communications business with other similar entities or divest this portion of the business if the oil and gas business of TALK becomes significant, so that management will ultimately focus on one business segment.
About: - ITalk, Inc iTalk, Inc. (OTCQB: TALK) is a publicly traded global provider of advanced communications and mobile broadband services. The Company utilizes innovative and disruptive technologies, including Voice-over-IP (VoIP), nationwide 3G/4G mobile broadband networks, smartphones, and mobile applications ("apps") to offer consumers the highest-quality low-cost no-contract alternatives to voice, data, and mobile services from major national carriers. For further information, visit www.italkmobility.com.
Disclaimer/Safe Harbor: Statements about the Company's future expectations and all other statements in this press release other than historical facts, are "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. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. The above information contains information relating to the Company that is based on the beliefs of the Company and/or its management as well as assumptions made by and information currently available to the Company or its management. When used in this document, the words "anticipate," "estimate," "expect," "intend," "plans," "projects," and similar expressions, as they relate to the Company or its management, are intended to identify forward-looking statements. Such statements reflect the current view of the Company regarding future events and are subject to certain risks, uncertainties and assumptions, including the risks and uncertainties noted. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove to be incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated, expected, intended or projected. In each instance, forward-looking information should be considered in light of the accompanying meaningful cautionary statements herein. Factors that could cause results to differ include, but are not limited to, successful performance of internal plans, the impact of competitive services and pricing and general economic.
Contact:
iTalk, Inc.
David F. Levy
CEO
marketing@italkmobility.com
investor@italkmobility.com
Berge may actually have to land a big deal after all, sure as hell can't dump any more shares on us. We ain't footing the bill for it. Hard to believe he's done this to his company and to us, but he did. So much potential this time last year (before all the lies: no plans for r/s, notes almost done, bs), such a shame it is where it is. The trust is gone, the volume is right there with it.
Looking good here! Should be an interesting day tomorrow.
Wan't the 10k due yesterday?
None of us had any way of knowing that Berge was going to make the poor choices he did. When I found Bergio, I saw massive potential and was excited about what the future "seemed" to have in store here. There was alot of time spent a building the wiki and presenting as much information as possible. Was I wrong in believing that Berge could build a successful company/stock, yes. Was it anyone's fault here for HIS choices, hell no.
We didn't make those choices that ruined the company and stock. I've lost more here than most. It's sickening where this stock is sitting right now. I don't expect Berge will ever be able to turn this around at this point. He's screwed us all by the lies in Feb. (end of conversion PR), the subsequent r/s after stating he wouldn't do it and wasn't even thinking about it (have that recorded). Many believed in this company at varying degrees or wouldn't have stuck around this long.
I no longer believe a word Berge says and haven't talked to him since before the r/s. It's a damn shame too, he could have been very successful. I wish everyone luck and hope for some kind of pop so we can all get out with something. Not holding my breath on that one though.
I agree 100%, he lied and no longer trusted by anyone. I've lost more here than I care to say. Now, it's all self-evident. He's dishonest at best, I don't think he'll ever change his ways. It's a shame, he could have been very successful had he made the right choices. He's screwed himself more than he has us. When Fife/Iliad realize they can't dump their shares on us anymore, they'll cut him off too. A company running in the red won't be around long without funding. Karma has a way of making up for bad choices.
According to the NT 10-K they have until the 15th to file. Calendar days, not business days. Looking forward to it and a surprise PR would be welcomed.
Well, now we got that out of the way. Time to move back up. TALK
Sure wish some would learn how to trade...
Great post, loved the Sprint commercial TALK
Interesting links here regarding possible buyout. There are other relevant links but this is what I could find quickly.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108379163
and here...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108465685
Adding... volume precedes price. We have volume, big move is imminent.
Thanks EZ, what's on the bid could easily take us into the mid 30's. Not much selling the past couple days, people are adding/holding. Rapid upward movement certainly possible here with small hits to the ask. Thanks again for the L2 shot
$TALK - News just released! :
DataJack : Unified Signal, Inc. Announces Launch of iTalk, Inc. MVNO
http://www.4-traders.com/DATAJACK-INC-15867086/news/DataJack--Unified-Signal-Inc-Announces-Launch-of-iTalk-Inc-MVNO-19443845/
Wow 12.5m BID Showing. BOOM Time near!
Massive bid growing, nearly 5m was showing @ .0014 just a min. ago. TALK
When you say a separate deal, do you mean separate company? Reason why I ask, if you look closely at these two devices (one from italkmobility website and the other from freedompop) they look exactly the same (aside from the name in the middle of the LCD display). The hardware and firmware appear to be identical. Right down the the hours, min. and seconds in the display!
I realize one of the freedompop devices look identical to iTalk's hotspot. Is Freedompop owned by iTalk? I'm not clear on this.
Now this is VERY interesting, thank you! The Freedompop "Freedom Spot Overdrive Pro" (Link here: https://www.freedompop.com/home.htm#products ) is EXACTLY the same device as the iData personal Hotspot (Link here: http://www.italkmobility.com/productsmifi )
Based on this article (full article here), the following points are VERY interesting :
Any proof of Freedom Pop being in talks with Sprint would be appreciated.
TALK - damn, look at the bid support! Going higher fur sure
TALK looking good. Nice bid support ahead of news/Q? Could get interesting.
Getting the feeling something may be about to happen... very soon.
Done with his BS PR's and BS note holders, he had a chance to turn this around and blew it royally. Sadly, I thought he was better than this. But through his own actions it's clear, he's not. If his products were selling, he wouldn't need convertible debt... Operations alone can't keep the ship afloat and it's filling up with water.
Faccia was the one product that could have changed it all. He's been sitting on it for 1.5 years waiting for the wholesaler. Well, like everything else Bergio, it didn't workout and there was no backup plan. The store opening seemed like a desperate move, yet costly to shareholders (reason for the r/s and continuing decline in MC). He needs to hire a CEO so he can focus on products (something he is good at). Running a company, not so much.
TALK off to a strong start this AM. AK
Thanks BK, being new here I was just wondering
Nice sized dump... What's up with that?
Very interesting trading today, anyone know the catalyst? You know, besides a company with an expanding product line, sales and customer base?