CXM Cardium Pharma Clinical Trial

[sofakingcool]

has anyone else have any DD on this company. looks like to release results this month.

Cardium Therapeutics, Inc. (CXM.A) Key Developments | Stocks | Reuters.com

Scientific Journal Gene Therapy Reports That Cardium's Gene Activated Matrix Technology Accelerates Periodontal Tissue Regeneration - MarketWatch

[johnny]

CXM is expected to release top-line results by September 30th

Cardium Completes Initial Patient Evaluation Period for MATRIX Phase 2b Excellarate Clinical Study

Scientific Journal Gene Therapy Reports That Cardium's Gene Activated Matrix Technology Accelerates Periodontal Tissue Regeneration

[stockgirl88]

Here's some Background info guys; Friend of mine who is a retired registered nurse took a look and put this together after I asked her opinion.
Not a sure thing but definitely something to keep an eye on =)

CXM (Cardium) has an average volume of approximately 104,000 shares a day, sells on the American stock exchange, and has 47.3 million shares outstanding. Their cash position was pretty bad at June 30th but they sold off Inner Cool on July 24th and received $11.25 million dollars, which helped their cash position. They are on a watch list to be delisted from the American Stock Exchange on June 23, 2010.

Their product, Excellarate, is for non-healing lower extremity wound healing (as one would find with diabetics). Phase IIb results (safety & efficacy) are due to be released by September 30th. The major endpoints of this clinical trial are objective and can be easily measured, they include wound closure incidence (number of patients achieving complete wound closure, wound closure efficiency (% reduction in wound size), and wound closure rate (wound closure trajectories over time). These are clearly objective measurements and most good nurses know exactly how to exactly measure a wound - we learn this in nursing school! So I would expect that there would be no problems in running this clinical trial - this is a huge plus.

There is a huge need for better wound healing agents due to the ever expanding group of diabetics who are prone to lower extremity wounds that do not heal on their own as well as the elderly with their bed sores. With what we have to work with now, closing a large open wound on a diabetic can take up to a year of treatments and many times ends up with amputation. Very costly! Excellarate is a one time treatment, very cost efficient.

Cardium would need to set up a Phase 3 clinical trial if the results from Phase IIb are as they expect. The company does expect to have good results once this trial is unblinded. They mentioned that the blinded data looks promising with fully healed wounds seen.

[ajfavstocks]

I don't see any Institutions buying at this time

[stockgirl88]

yep you are right.
It's a relatively unknown company so far as I've seen. Not sure but companies who have run up relatively fast, $VNDA, $OPXA, $JAZZ weren't really well known and now have grown considerably since release of news or approval. These are all best case scenario though right?

Anyway just a tidbit. It's a cheap price and worth the gamble possibly.

[jokesola]

Anybody owning MCUJ? The volume started changing last two trading days.

[pcstock]

Which companies are competing with CXM?

[sofakingcool]

Have not found any competiters yet looking online. Dramatic volume increase today and edgeing up slowly. Could be a good sign.

[LRP]

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Phase IIb data soon
« Thread Started Yesterday at 5:01pm » [Quote] [Modify] [Delete]
Cardium will soon be releasing data for their MATRIX Phase 2b Excellarate Clinical Study.

The study evaluates excellarate for diabetic foot ulcers, a condition that commonly occurs among the aged with diabetes. These ulcers often get infected with gangrene resulting in amputation.

Prior phase I/II data is as follows:
15 patients having diabetic foot ulcers that did not heal using conventional techniques. Based on the data obtained, Excellarate appeared to be safe and well tolerated in patients with diabetic foot ulcers. In addition, in the 12 patients that completed the treatment protocol and follow- up, over 80% of the patients exhibited complete closure of previously non- healing wounds by 14 weeks. Single dose applications were administered in 70% of the patients and the remaining patients received a weekly dose application over a four-week period.
http://www.redorbit.com/news/health/6150...._and/index.html

About the Phase IIb study:
- enroll approximately 210 patients at up to 30 U.S. sites.
- patients diagnosed with Type I or II diabetes with a non-healing foot ulcer present that have been present for at least six weeks and who have failed standard of care therapy.
- The five arms of the study will include standardized care, consisting of surgical debridement, dressing changes, and weight off-loading devices, one or two applications of placebo, and one or two applications of Excellarate.
- The study's primary endpoint is complete ulcer closure at 12 weeks or earlier.
- Secondary endpoints will be time to complete ulcer closure, change in ulcer area, durability of wound closure, and safety and tolerance.

From what I can gather, they were low on cash, though that has been alleviated by the recent sale of their InnerCool technology to Philips for 13 million and a private placement of 4.5 million in common stock. It looks like they are now debt free and have enough cash for 2010.


More info via the following links:
http://www.reuters.com/finance/stocks/ke....20090914140000
http://www.bio-medicine.org/medicine-tec....ss-U-S--1533-1/
http://www.cardiumthx.com/flash/index.html

[waves]

From the above post, CXM looks good. Their upcoming phase 2b result seems promising. If the result is good, it will push the stock much higher, and they have a good chance to get the positive result. They improved the financial situation recently, and also have a pending FDA 510K. However, betting on clinical trial results has big risk.