Key Developments: Aastrom Biosciences Inc (ASTM.OQ)
0.58USD
8 May 2013
$0.02 (+2.70%)
$0.56
$0.57
$0.58
$0.56
29,875
73,967
$2.34
$0.52
Latest Key Developments (Source: Significant Developments)
Aastrom Biosciences Inc Announces Strategic Change In Research And Development Programs; Executes Corporate Restructuring
Aastrom Biosciences Inc announced strategic change in research and development programs to focus on the clinical development of lead product, ixmyelocel-T, for the treatment of dilated cardiomyopathy (DCM). Aastrom, which recently initiated the Phase 2b ixCELL-DCM clinical trial, previously received a U.S. orphan drug designation for the use of ixmyelocel-T in the treatment of DCM. As a result of the strategic change, Aastrom will stop enrollment and end the Phase 3 REVIVE clinical trial in patients with critical limb ischemia (CLI). In addition, the Company is executing a corporate restructuring that will reduce staff and operating expenses by approximately 50%. The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled Phase 2b study. Approximately 108 patients will be enrolled at about 30 sites in the U.S. In the study, ixmyelocel-T is administered via catheter-based injections to patients with advanced heart failure due to ischemic DCM. The primary endpoint of the trial is the average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure. Patients will be followed for a total of 12 months. Full Article
Aastrom Biosciences Inc Names Dominick C. Colangelo President And CEO
Aastrom Biosciences Inc announced that the company's board of directors has named Dominick C. Colangelo, Esq., as President and Chief Executive Officer (CEO) of Aastrom. Mr. Colangelo will also serve as a member of the Aastrom board of directors. Full Article
Aastrom Biosciences Inc Announces Management Change-Form 8-K
Aastrom Biosciences Inc reported in its Form 8-K that effective as of December 14, 2012, Daniel Orlando will assume the position of interim Chief Executive Officer (CEO) and President of Aastrom Biosciences, Inc. (Company) and Tim M. Mayleben, who announced his retirement in October 2012, will step down from his role as the Chief Executive Officer and President. Mr. Mayleben will continue as a member of the Board of Directors and will continue to be available as a consultant to assist with management transition issues. Full Article
Aastrom Biosciences Inc Announces CEO Tim M. Mayleben Plan To Retire
Aastrom Biosciences Inc announced that Tim M. Mayleben has decided to retire from his position as the Company's president and Chief Executive Officer (CEO) once the Company has hired his successor. As a result of his decision, the Aastrom board of directors has initiated a search for a new CEO. In addition to remaining as president and CEO until a successor is found, Mr. Mayleben will continue to serve as a member of the board of directors after the transition. Full Article
Aastrom Biosciences, Inc. Announces Common Stock Exchange For December 2010 Warrants
Aastrom Biosciences, Inc. announced that it plans to exchange for common stock up to 10,000,000 of its outstanding warrants issued in December 2010. The warrants have an exercise price of $3.22 and an expiration date of December 15, 2015. Aastrom is exchanging one share of common stock for every two December 2010 warrants surrendered by the warrant holders. The purpose of the exchange is to improve the Company's capital structure by reducing the number of outstanding warrants which have complex and dilutive features, and by reducing the number of fully diluted Aastrom shares by over 5% if all of the 10,000,000 December 2010 warrants are exchanged. As part of this effort, earlier Aastrom completed privately negotiated warrant exchange agreements on the terms outlined above with holders of 7,666,666 of the December 2010 warrants. Accordingly, Aastrom issued 3,833,334 shares of common stock. Full Article
Aastrom Biosciences, Inc.'s Ixmyelocel-T Protect Heart From Damage In Murine Model Of Heart Failure
Aastrom Biosciences, Inc. announced results from a preclinical study demonstrating the ability of ixmyelocel-T to protect the ischemic heart from damage in a murine model of heart failure. Results were presented at the 18th Annual International Society for Cellular Therapy Meeting in a poster presentation entitled 'Ixmyelocel-T protects the heart from damage in a murine model of heart failure.' In a blinded, vehicle-controlled study, a murine model of non-acute left anterior descending coronary artery occlusion was used to evaluate ixmyelocel-T as a potential treatment for dilated cardiomyopathy. Hearts were analyzed four weeks following injection and those in the treated group experienced a decrease in infarct length compared to the vehicle control group. The results were consistent between two lots of ixmyelocel-T (Lot 1: 2.72+/- 0.77 vs. 6.14+/- 0.43, P<0.001; Lot 2: 3.80+/- 0. 37 vs. 7.34+/- 0.47, P<0.001). Animals treated with ixmyelocel-T demonstrated a reduced mortality compared to control (22% vs. 44%) and decreased infarct size and increased survival when compared to a vehicle control group. xmyelocel-T therapy is a patient-specific, expanded multicellular therapy comprised of a mixture of cell types cultured from bone marrow mononuclear cells. Early studies have shown ixmyelocel-T may have positive effects on activities such as tissue remodeling, immunomodulation and the promotion of angiogenesis, which can contribute to severe, chronic cardiovascular diseases. Full Article
Aastrom Biosciences, Inc. Announces Final Results From RESTORE-CLI Phase 2b Clinical Trial For Ixmyelocel-T
Aastrom Biosciences, Inc. announced that final results from the Company's RESTORE-CLI Phase 2b clinical trial for ixmyelocel-T were published in the peer-reviewed journal Molecular Therapy. The Phase 2b clinical results demonstrated that treatment with ixmyelocel-T improved time to treatment failure in patients with critical limb ischemia (CLI) compared to the control group, and in the subgroup of patients with wounds at baseline demonstrated an improvement in amputation free survival. The RESTORE-CLI study was a randomized double blind Phase 2b clinical trial comparing the efficacy and safety of ixmyelocel-T to placebo. Patients received a one-time treatment of ixmyelocel-T of 20 intramuscular injections in the treated leg and were followed for 12 months. The results also showed no major safety issues associated with treatment with ixmyelocel-T. In the study, efficacy assessments included time to first occurrence of treatment failure, defined as major amputation, all-cause mortality, doubling of total wound surface area from baseline, or de novo gangrene. A total of 48 patients were treated with ixmyelocel-T and 24 received a placebo. Adverse event rates in both groups were similar. Patients in the treatment arm showed a 62% reduction in risk relative to placebo in the primary efficacy endpoint of time to first occurrence of treatment failure (p =0.0032). Full Article
Aastrom Biosciences, Inc. Completes $40 Million Financing
Aastrom Biosciences, Inc. announced that it has completed a $40 million private placement with Eastern Capital Limited in a financing structured and arranged by MLV & Co. Net proceeds to Aastrom, after placement fees and other offering expenses, are approximately $38 million. The Company intends to use the net proceeds from the financing for general corporate purposes, including research and development expenses related to the pivotal Phase 3 REVIVE-CLI clinical trial with ixmyelocel-T initiated in February 2012. At closing, Aastrom issued approximately 12,300 shares of Series B convertible preferred stock to Eastern Capital at a price of $3,250 per share. The shares will accrue dividends at a rate of 11.5% per annum during the 5-year term. The Series B preferred stock is convertible into shares of the Company's common stock only after March 8, 2017 at a rate of 1,000 common shares for one preferred share. There were no warrants issued in connection with the financing and Eastern Capital will not take a board seat. Full Article
Aastrom Biosciences, Inc. Announces Positive 12-Month Safety And Efficacy Data From IMPACT-DCM Phase 2 Clinical Trial For Ixmyelocel-T in Treatment Of Dilated Cardiomyopathy
Aastrom Biosciences, Inc. announced that 12-month follow up data from the IMPACT-DCM clinical trial for ixmyelocel-T showed that treatment was well-tolerated and that efficacy observations were consistent with improved function of impaired myocardium in patients with dilated cardiomyopathy (DCM) including ischemic cardiomyopathy (ICM) and idiopathic dilated cardiomyopathy (IDC). Results were reported today by Amit N. Patel, associate professor of surgery at the University of Utah School of Medicine and national principal investigator for Aastrom's U.S. Phase 2 IMPACT-DCM clinical trial, in a poster presentati. In the study, 40 patients diagnosed with ICM or IDC were randomized 3 to 1 to either a single administration of ixmyelocel-T or standard of care and were followed for 12 months. In the ixmyelocel-T treatment group, bone marrow cells were cultured using Aastrom's technology to expand the number of mesenchymal cells, monocytes and macrophages while retaining many of the mononuclear cells. This combination has been associated with biological activity that promotes tissue remodeling, immunomodulation, and promotion of angiogenesis. Twenty-one of the 25 (84%) ixmyelocel-T patients completed the 12-month visit. Seven of 15 (47%) of the control patients completed the 12-month visit, while an additional 5 of 15 (33%) of the control patients enrolled into the extension phase of the study and received ixmyelocel-T treatment. Full Article
Aastrom Biosciences, Inc. Announces Agreement From FDA On Special Protocol Assessment For Phase 3 Clinical Trial In No-Option Critical Limb Ischemia Patients
Aastrom Biosciences, Inc. announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) for the design of the Phase 3 REVIVE-CLI clinical trial of ixmyelocel-T, the Company's expanded multicellular therapy, in patients with critical limb ischemia (CLI) who have no other treatment options. Aastrom's Phase 3 clinical trial will enroll up to 594 no-option patients with CLI at approximately 80 clinical sites across the U.S. This multi-center study will be randomized, double-blinded, and placebo-controlled and will include only CLI patients with existing tissue loss (e.g., ulcerations and/or dry gangrene). In the U.S., there are approximately 250,000 CLI patients with tissue loss. Patients with CLI who have tissue loss are five times more likely to experience an amputation within 12 months of diagnosis. In the RESTORE-CLI Phase 2b clinical trial, which was fully controlled cell-therapy study ever conducted in CLI, patients who received treatment with ixmyelocel-T showed a favorable safety profile and clinically meaningful and statistically significant benefit in time to treatment failure events. Aastrom expects to present the data from the RESTORE-CLI Phase 2b clinical trial at a major medical meeting in November 2011. Full Article
Aastrom Biosciences ends drug trial, to cut half its workforce
- Aastrom Biosciences Inc said it would end the late-stage trial of its drug to treat critical limb ischemia (CLI), a form of peripheral arterial disease, and cut about half of its workforce, driving its shares to an all-time low.
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