Cytomedix ($CMXI) in American Heart Journal For Positive Phase I Clinical Data Using ALD-201 to Treat Ischemic Heart Failure

Cytomedix, Inc. (OTCBB: CMXI) develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDH(br)") technology, currently in a Phase 2 trial for the treatment of ischemic stroke.

Daily Dose Conclusion: This is not new news for Aldagen (now part of CytoMedix) but does remind us that among the various cells in bone marrow, there are specific populations of cells, in this case, ALD-br cells, that are prolific elicitors of neoangiogenesis (capable of forming and fostering new blood vessel formation) . Our expectation is that CytoMedix will focus on CLI trial. Recall that Aastrom is now in a pivotal trial with their bone marrow (expanded cells) and PluriStem (PSTI) is hoping to begin their Phase II trial with their placental derived (allogeneic) cell product. From a COGS view point it’s likely that PSTI's product will be the cheapest to make, and Aastrom has the lead to the marketplace. Also know that in the wings are the adipose derived players such as Cytori and even device make Thermogenesis (KOOL). This could be local processing and also a very cheaply produced product. As such we have our concerns regarding the classic SWAT (Strength, Opportunities, threats & Weakness) and how each of the CLI players will score on these metrics.

Today's Press Release: CMXI announced that positive data from a Phase 1 clinical trial of ALD-201 to treat ischemic heart failure were published in the March 2012 online edition of the American Heart Journal. In the study, ALD-201 was considered safe and demonstrated initial evidence of improved blood flow and improved clinical status. ALD-201 is a population of biologically instructive adult stem cells (aldehyde dehydrogenase bright cells, or ALDH(br)) that are selected from the patient's own bone marrow using the ALDH enzyme as a marker. The article is titled:

"Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase-bright stem cells in patients with ischemic heart failure." 

The randomized, double-blind, placebo-controlled Phase 1 study included 20 heart failure patients with no treatment options. The primary end point was safety and secondary end points included several well-accepted clinical measurements. The patients received either an injection of ALD-201 directly into the heart muscle, or an injection of an equivalent volume of placebo using the same catheter delivery system. Investigators assessed patients for endpoints for the first six months after the injection and then followed them for an additional six months.

In the study ALD-201, including injection into the myocardium, was considered to be safe and well tolerated. After six months, the subjects who received ALD-201 demonstrated an improvement in MaxVO2, a measure of the body's ability to take up oxygen during exercise, while the placebo group did not. These findings support the ability of ALDH(br) cells to promote angiogenesis and restore blood flow to the ischemic heart muscle.

Commenting on the results of the Phase 1 study, Principal Investigator, Emerson C. Perin, M.D., Ph.D., Director of the Stem Cell Center at the Texas Heart Institute at St. Luke's Episcopal Hospital, and the Adult Cardiology Texas Heart Institute at St. Luke's Episcopal Hospital in Houston, noted,

"The preliminary evidence suggests improved perfusion and a trend toward improved functional capacity in no-option heart failure patients treated with ALDH(br) cells. Importantly, we presented a unique approach for selecting a diverse population of active cells for cell therapy by using a physiologic rather than a single phenotypic marker, which may result in the isolation of a more efficacious population comprising the multiple cell types required for ischemic repair."

About Ischemic Heart Failure

Ischemic heart failure is caused by a reduction of blood flow to the muscles of the heart, which is most commonly caused by an obstruction of the arteries feeding blood to the heart tissue. As a result, the insufficient provision of oxygen and nutrients reduces the heart's ability to pump blood efficiently to the rest of the body. Current treatment options for ischemic heart failure include surgical procedures, bi-ventricular pacers, drug therapies, implantable cardiac defibrillators, and ventricular assist devices. For some patients, these treatments are not effective or appropriate. Once ischemic heart failure patients have exhausted all potential revascularization options, their only other option is a heart transplant, if they are eligible.

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Aastrom (ASTM): Reports the Quarter, JMP Makes Positive Comments

Aastrom (ASTM): Reports the Quarter its great to have the cash but...

Highlights As follows:

1. The company ended 2011 with cash of $5.5MM which, together with $40MM raised last week should fund current operations through mid 2013.
2. The Phase III trial for ixmyelocel-T in critical limb ischemia (CLI) has begun. Enrollment will be monitores (this is a large trial, how long will it take ?).
3. Aastrom is planning to move ahead with a phase IIb trial in dilated cardiomyopathy (DCM) by this summer. Reesults from the Phase 1b trial are expected this quarter.

Daily Dose Conclusion: Its great that Aastrom is financed but we convertible debt is atypical for Biotech's and raises the importance of the CLI trial. We believe the trial is highly powered and if all goes well will show good results but as mentioned previously, the "B" in binary just got a bit Bigger.  CLI is an unmet medical need. Aastrom does appear to have the jump on the field (versus Pluristem (PSTI) and Aldagen / Cytomedic

Aastrom ($ASTM) patient enrollment

Aastrom Biosciences (NASDAQ: ASTM) announces initiation of patient enrollment in REVIVE phase III trial of Ixmyelocel-T ($1.79):

• ASTM has begun patient enrollment in the REVIVE Phase 3 clinical trial to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with critical limb ischemia (CLI).
• The primary endpoint of the trial will be amputation-free survival at 12 months.
• The REVIVE clinical trial has also been granted Fast Track designation by the FDA.

Daily Dose Conclusion: This is positive as the trial gets underway. Investors are concerned that the lack of a partner means Aastrom has to fund this trial alone, which will be expensive. The likely conclusion then is that Aastrom will need to raise additional capital. At this valuation however a good amount of that is likely factored into he share price. Other earlier players in CLI include Pluristem (PSTI), and Cytomedix - Aldagen (CMXI). We have also recently written on Thermogenesis (KOOL) working in the CLI space.

Medistem ($MEDS) Initiates Collaboration With Chinese Conglomerate Aimed at Clinical Development of Endometrial Regenerative Cells for Critical Limb Ischemia

Medistem Inc. (OTC: MEDS) announced today initiation of joint efforts with the Chinese conglomerate, Shanghai Jia Fu Medical Apparatus Inc, in developing the Endometrial Regenerative Cell (ERC) “universal donor” stem cell product for the Chinese market. The initial focus of the collaboration will be treatment of critical limb ischemia, an advanced form of peripheral artery disease.

Medistem has previously received FDA clearance to begin a Phase I clinical trial using the ERC stem cells in this patient population. A scientific publication providing the rationale and supporting data for utilization of ERC in treatment of critical limb ischemia may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

Video on MediStem's Source of Cells:

Daily Dose Conclusion: Critical Limb Ischemia (CLI) is getting crowded. Aastrom (ASTM) is in the lead in the US with a P3 FDA trial in motion. With that said the market capitalization for Aastrom has fallen sharply as trial has been expanded and costs rising. Definitive Phase II data should have translated into a pharma partnership but the Phase IIB data read missed the primary endpoint as the AFS (Amputation free survival rate) of the control group fell (it was unusually high in the PIIa read-out). As such it seems that Aastrom has to go it alone now. Also aggressive in the CLI space is Pluristem (PSTI), Aldagen (now part of Cytomedix: OTC/BB:CMXI) and even device company Thermogenesis (KOOL) announced CLI data from a trial in India. We believe that in CLI COGS (cost of goods sold) and the ability to retreat patients will be significant factors.

Aastrom (ASTM) fall in market cap appears over-done at this point but smart investors will wait for a financing to be completed before jumping in. Data is at least 2 years away so there is no rush. Ditto for the other CLI players. In terms of Cytomedix we are very concerned that the strategy is flawed as Aldagen's product (ALDH-br cells) look expensive to make and are in early stages behind Aastrom and Pluristem. Is Cytomedix funded for a phase II CLI program ?  Stay tuned.

ThermoGenesis ($KOOL) now in CLI ! (video)

ThermoGenesis Corp (NASDAQ: KOOL) press released an update on their Res-Q clinical evaluations:

ThermoGenesis Provides Update on Res-Q® Clinical Evaluations at Leading Stem Cell Therapy Conference

INITIAL DATA SHOW POSITIVE OUTCOMES IN TREATING CRITICAL LIMB ISCHEMIA AND LONG BONE FRACTURES

What is Res-Q ?  This is a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP). The product is being tested in India in a trial co-sponsored by ThermoGenesis and Totipotent SC, the company's distributor for the Res-Q in India.

The trial has evaluated n=10 of n=15 planned patients with advanced CLI. Safety and AFS (limb salvage) at one year are being evaluated. Secondary endpoints such as ABI (ankle brachial index), six minute walk test, and resting pain are showing good results.

In addition a second trial is evaluating n=16 of n=20 patients with non-union or delayed union fracture of a long bone (tibia) who have undergone composite grafting with autologous bone marrow cell concentrate to evaluate the procedure's safety and effect on fracture healing. Long bone fractures represent an unmet medical need that the med tech companies have been chasing for years. So far the system has shown no intra-operative complications, and one non-device related adverse event. Of nine patients who are now out three-to-six months post-treatment, four have fractures that have united and four have experienced partial unions of the bone fracture which is quite hopeful.

Daily Dose Conclusion: Few are paying attention to KOOL as a therapeutic player in CLI or bone fractures and as a potential challenger to Cytori or even Aastrom or Pluristem in CLI. This is worth watching.

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ThermoGenesis Corp (KOOL) - ReOrganizing ?

ThermoGenesis Corp (NASDAQ: KOOL) announced a management transition in conjunction with tactical realignment of company in this press release.

Thermogenesis is an automation/tool's supplier in and around the world of cell therapy. The company has had their struggles with the business model and a run towards profitability which also seems to be a year away. News today that Matthew Plavan (currently CFO / EVP, Business Development), will become CEO and a board member as well as the CFO is tough to read. According to the press release:

• Plavan will replace J. Melville Engle, (who has retired from his position as Chairman and CEO).
• The company will cut eight additional positions and provide additional details on its new operating structure and objectives during its Q2 fiscal 2012 conference call on Thursday, 9-Feb.
• KOOL expects to record one-time expenses of approximately $500,000 related to the reorganization announced in Q3 of fiscal 2012 BUT the restructured operations should result in an annualized expense reduction of approximately $2M (according to KOOL.

Daily Dose Conclusion: No Rush to jump into KOOL on a reorg news but this is a great company, strong technology that at some point could be acquired by a bigger fish.