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CXM - Phase 2b data on OCT 14th...
Cardium Announces Planned Release of Data from Matrix Excellarate Phase 2b
Cardium Announces Planned Release of Data from Matrix Excellarate Phase 2b Clinical Study and Acceptance of Phase 1 / 2 Study for Publication in Wound Repair and Regeneration
SAN DIEGO, Oct. 1 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) announced plans to report on preliminary safety and efficacy data from its Matrix Phase 2b Excellarate clinical study. Based on guidance from Cardium's independent clinical data management company which is currently completing the statistical analysis of all data for the Matrix clinical trial, Cardium expects to receive the locked unblinded data set and be in position to announce preliminary results on or before October 14, 2009. The Company also plans to hold a webcast to review the clinical data, details of which will be provided with announcement of the Matrix clinical results.
(Logo: http://www.newscom.com/cgi-bin/prnh/...18/CARDIUMLOGO)
Cardium also announced that positive results from the Phase 1 / 2 clinical study of Excellarate have been accepted for publication in Wound Repair and Regeneration, the peer-reviewed medical journal of the Wound Healing Society. The article, entitled Treatment of Nonhealing Diabetic Foot Ulcers with Platelet Derived Growth Factor Gene-Activated Matrix (GAM501): Results of a Phase 1/2 trial (Mulder, et al) is expected to be published and available online in early October 2009.
did they file for FDA
Where do you see the stock heading, Is it a Buy at current price?
numbers
what the numbers looking like
I have copied this below. Not my DD, but thought to pass it along....
Positive results we will RETEST the 52 week high of $3.12, however with data meeting all endpoints and showing great efficiency, I see this soaring even pass the 52 week high and easily going more than 100%-150%
IN THERE RECENT 8-K FILING ON OCT. 5TH, they state that "On October 1, 2009, Cardium Therapeutics, Inc. (“Cardium”) issued a press release announcing that it plans to report on preliminary safety and efficacy data from its Matrix Phase 2b Excellarate clinical study on or before October 14, 2009 and the acceptance of the Phase 1/2 clinical study for publication in Wound Repair and Regeneration. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein"
All indications seem to make their results for Phase 2 seem very promising and very positive. I am extremely BULLISH on CXM results. Please view link below and research package i have put together.
Convincing images of healing and effectiveness of Matrix Excellarate.
http://phx.corporate-ir.net/External...xUeXBlPTM=&t=1
Other REASONS WHY PHASE II WILL BE POSITIVE:
-Also Reuters article release Tuesday, 25 Aug 2009 03:09pm EDT
Cardium Therapeutics Inc. announced that all patients enrolled in the Company's MATRIX clinical study have now completed their initial 12-week evaluation period and that it plans to provide detailed safety and efficacy data in late September 2009. Based on a continuing review of safety information, the Excellarate product candidate appears to be both safe and well-tolerated, with no serious adverse events attributed to use of the study product. With respect to efficacy, while the study remains blinded until all key data are collected and fully analyzed, the Company and investigators are encouraged by several observations related to wound healing in the enrolled patient population. First, a number of study investigators have observed very rapid reductions in ulcer area after initial treatment (whereas the ulcers had not substantially reduced in size during a prior 2-week run-in period that was used to screen all patients entering the study). These findings are similar to what had been observed in the Phase 1/2 study.
Cardium Therapeutics, Inc. (CXM.A) Key Developments | Stocks | Reuters.com
-From the 8/31/09 8-K SEC Filing-
NASDAQ | SEC Filing
SAN DIEGO, CA – August 25, 2009 – Cardium Therapeutics (NYSE Amex: CXM) today announced that all patients enrolled in the Company’s MATRIX clinical study have now completed their initial 12-week evaluation period and that it plans to provide detailed safety and efficacy data in late September 2009.
The Phase 2b MATRIX clinical trial is a prospective, randomized, double-blind, placebo-controlled study of Excellarate™ for the potential treatment of chronic diabetic foot ulcers. The clinical study is designed to evaluate safety and key efficacy measures including complete wound closure, time to complete wound closure, absolute and percent change in ulcer area, and wound healing trajectories at various time points, as well as a wide range of other safety and comparative healing metrics which will be used to develop a Phase 3 clinical study. In addition, following the initial 12-week efficacy evaluation period, patients whose wounds have successfully closed are now being followed for three months to further evaluate wound healing durability.
“With the data set now complete for the initial 12-week evaluation period, we look forward to completion of the formal statistical review and analysis and, as previously reported, we expect to announce safety and efficacy data around the end of September,” stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics. “During the course of this landmark gene therapy trial, we have observed some remarkable healing responses, based on a one or two physician-administered treatment protocol, instead of current therapies which require multiple treatments by physicians or patients either on a daily or weekly basis for up to 20 weeks. We look forward to reviewing the MATRIX study’s complete data set.” ( Click here to see selected information from Cardium’s May 14, 2009 webcast or visit the Investor section at Cardium’s website at Cardium Therapeutics, leading a revolution into new frontiers of cardiovascular medicine. ).
Observational Safety and Efficacy Insights
Based on a continuing review of safety information, the Excellarate product candidate appears to be both safe and well-tolerated, with no serious adverse events attributed to use of the study product.
-"According to Cardium, Excellarate is designed to require only one or two physician-administered treatments, in contrast to most diabetic wound healing agents or devices in use that require repeated administrations over a long term (weeks to months). Excellarate is also expected to be re-formulated as an easy-to-use single syringe that is pre-mixed and ready to be applied to patients' wounds. The reformulation will allow Excellarate to be maintained in a physician's office using a standard refrigerator (at a temperature of about 4 C) and is expected to have a shelf life of 15-18 months.
The phase IIb trial of Excellarate dubbed MATRIX, is a prospective, randomized, double-blind, placebo-controlled study for the potential treatment of chronic diabetic foot ulcers. The clinical study is designed to evaluate safety and key efficacy measures including complete wound closure, time to complete wound closure, absolute and percent change in ulcer area, and wound healing trajectories at various time points, as well as a wide range of other safety and comparative healing metrics which will be used to develop a Phase III clinical study."
"Foot infections are among the most serious complications of diabetes and may even lead to amputation when infections fail to respond to therapy. Statistics reveal that about 600,000 diabetics get foot ulcers every year in the U.S. According to reports, appropriate treatment of foot ulcers may prevent up to 85% of amputations"
CDTP.OB Cardium - Waiting To Decipher MATRIX
Other key developments:
-Tons of Inside buying earlier this year
As I said ALL INDICATIONS lead me to believe the results will be very positive and will send this soaring, possibly doubling or almost tripling up your money 100-200% when results are announced. I AM EXTREMELY BULLISH ON CXM!
-Positive results from phase I look extremely promising
-Results in pictures show the evidence!!!
-Setting a date to announce Data is ALWAYS a positive & BULLISH note as they WANT ALL EYES looking at CXM when they annouce their POSITIVE RESULTS! WHICH WILL HAPPEN ANYTIME BETWEEN TODAY AND WEDNESDAY!
DIGGING DEEPER:
A key note in report from -From the 8/31/09 8-K SEC Filing-
"Observational Safety and Efficacy Insights. Based on a continuing review of safety information, the Excellarate product candidate appears to be both safe and well-tolerated, with no serious adverse events attributed to use of the study product. "
Up 22% this morning
up another 10% today
What is it expected to hit?
Positive announcement out and it dropped. Thoughts?
- Bill
Lots of profit takers, after news. They have a conference call at 5pm, it may go up later in the day.
I sold most in premarket - after playing a few of these, it seems premarket and aftermarket before news is expected, you can sell at the best price.
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