NeoStem's heart attack drug advances at faster pace, posts Q2 results
NeoStem (AMEX:NBS) announced Monday its AMR-001 drug for the treatment of acute myocardial infarction (AMI), or a heart attack, is progressing faster than anticipated toward phase two clinical trials.
NeoStem said it has chosen to discontinue the sale of certain drug intermediates to pharamceutical companies in order to create capacity within its existing production lines for higher margin products in the future, namely its AMR-001 drug candidate, which it received from its acquisition of Amorcyte in mid-July 2011.
Progressing toward the start of a phase two clinical trial for the treatment of AMI, the drug is an autologous stem cell treatment designed to prevent major adverse cardiac events following an AMI.
"We believe that there are data from several published clinical trials, including ours, demonstrating the potential effectiveness of a cell-based therapy for preserving cardiac function and preventing the adverse clinical events that usually follow a large myocardial infarction," said Amorcyte CSO, Dr. Andrew Pecora.
"Our clinical trial of AMR-001 yielded significant results, forming the basis for the Phase II trial."
The phase two, placebo-controlled, double blind trial is expected to enroll 150 patients earlier than the planned beginning of 2012 start date.
"We are thrilled to see Amorcyte advancing through the FDA's drug development process and moving forward with the Phase II clinical trial," added NeoStem CEO, Dr. Robin Smith.
"We see tremendous potential pharmacoeconomic benefit in this therapy, which we believe could change both the clinical adverse events associated with serious heart attacks and improve a patient's quality of life, all with one therapeutic intervention."
NeoStem's positive outlook prompted its stock on the AMEX Exchange to jump 14.17% today, to trade at $0.725 per share as of 2:31 pm EDT.
In other news, the company, which is focused on developing stem cell therapies, posted a wider loss in its second quarter, largely on the decision to discontinue certain drug intermediates in its pharmaceutical business.
For the three months ending June 30, NeoStem reported a net loss of $10.6 million, or $0.13 loss per share, compared to a $5.4 million loss, or $0.11 loss per share, a year ago.
Revenues slipped to $18.5 million, down 5% from the same period last year, mainly due to a 17% drop in sales from its China-based pharmaceutical operations.
Still, NeoStem's China-based regenerative medicine segment, which deals with obtaining product licenses covering several adult stem cell therapeutics, posted revenues of $98,700, up from nil a year ago.
Revenues from its U.S. cell therapy business, which focuses on the development of cell therapies for oncology, immunology and regenerative medicine, and hosts adult stem cell collection facilities, were $2.2 million, up from $37,800 in the year-ago period.
The company said it is continuing its transition to cell-based therapies, evidenced by its strong sales growth in its U.S.-based business.
NeoStem said that the cell manufacturing capabilities of Progenitor Cell Therapy, which it acquired in January for $20.3 million, are a key advantage in the development of AMR-001, as well as future cell-based therapeutics candidates.