Patients in a clinical trial who received Osiris Therapeutics’ stem cell treatment within a week after experiencing their first heart attack showed "significantly less" damage and arrhythmia than those who received a placebo.
The interim one-year results are from a phase 2 trial of Prochymal involving 220 heart attack patients, ages 21 to 85.
"This study is the largest of its kind and provides key insights into the mechanism of action of mesenchymal stem cells in the setting of acute myocardial infarction," Lode Debrabandere, senior vice president of therapeutics at the Columbia company, said in a statement. "These important mechanistic observations are consistent with data obtained from our preclinical models and from the first placebo-controlled human trial with Prochymal published in the Journal of the American College of Cardiology. Given the quality of the data and highly encouraging results observed thus far, we are extending the trial's duration to capture a better understanding of the long-term clinical benefits ..."
Furthermore, the trial showed that the treatment is safe, with no toxicities seen in patients who received it. So far, there have been five deaths in the trial: two in the Prochymal group and three in the placebo group.
"For interventional cardiologists, keeping our myocardial infarction patients from progressing to heart failure is central to our mission," said Mark Vesely, principal investigator and assistant professor of medicine at the University of Maryland School of Medicine. "It is remarkable and very encouraging to see significant changes in clinically meaningful parameters this early in the study. We look forward to the additional data that will be gathered as the study progresses, which will help us to better understand both the magnitude and durability of the benefit to treatment."
Osiris also reported that it has won two U.S. patents that cover how Prochymal works to repair damaged cardiac tissue. The Columbia company said it now has 48 U.S. patents for its stem cell treatments.
It also said that it improved its patent estate in Europe and Australia for its stem cell treatments to reduce inflammation.
"These recent additions to Osiris’ patent estate, combined with the existing broad coverage of our pioneering [mesenchymal stem cell] platform technology, reinforce our ... portfolio and bolster our dominant position regarding the manufacture and use of mesenchymal stem cells for the treatment of a broad range of diseases,” said Chris Alder, the company's chief intellectual property counsel, in a statement. “We have invested significant time and resources building our intellectual property estate, and with the commercialization of Prochymal, we are preparing to take the necessary action to enforce our considerable rights.”
Prochymal is approved in Canada and New Zealand, and is available in seven other nations, including the U.S., under an expanded access program for certain patients, to treat acute graft-versus-host disease in children.
The product also is being tested in clinical trials to treat refractory Crohn’s disease and type 1 diabetes.
In other Maryland bioscience industry news:
Bioqual, a Rockville company that provides animal testing services for commercial and federal clients, is taking a big hit, as the National Cancer Institute won’t renew the sixth and final option year of its mice contract.
The contract, under which Bioqual bred, housed and handled genetically manipulated mice for the agency, now is due to expire Sept. 16, with the agency taking over the work then, Bioqual said in a statement. However, if that transition is not made on time, the sixth option year will be divided into four quarterly periods that can be renewed by the agency for about $950,000 each.
In the year ended May 31, Bioqual racked up $3.98 million in revenues from the contract, or 17 percent of its revenues for the year. In its next fiscal year, the company had anticipated revenues of $4.4 million under the deal; now it expects only $1.2 million at most.
The company said its expects to realize some operational savings from losing the final year of the contract, but not enough to offset to loss in revenues.
GlaxoSmithKline extended its tender offer for shares of Human Genome Sciences for a few more weeks and the Rockville biotech had the same response it's had since April: No dice.
The British pharma giant's offer of $13 per share, or $2.6 billion, was due to expire last week, was extended to July 20. Meanwhile, HGS, its longtime partner, said the offer undervalues the company.
The $2.6 billion offer represented an 81 percent premium on HGS's stock price when it was made in April.
HGS has said it will entertain offers until July 16; GlaxoSmithKline said it won't participate in that process.
So far, fewer than 1 percent of HGS shares have been tendered into the Glaxo offer, HGS said in a statement.
Meanwhile, Reuters, citing a confidential source, reported that Glaxo has lined up 12 candidates to replace the entire HGS board. Glaxo indicated in May that it might try the tactic in its takeover battle.
Together, the companies market a new lupus drug, Benlysta, and are developing other treatments for cardiovascular disease and diabetes.
Rexahn Pharmaceuticals has submitted an investigational new drug application to the Food and Drug Administration, seeking permission to conduct the first human study of its RX-5902 to treat advanced or metastatic solid tumors.
“Pre-clinical studies have shown that RX-5902 exhibits very potent anti-tumor activity in various cancers including melanoma, renal, ovarian and pancreatic," Rick Soni, president of the Rockville biotech, said in a statement. "Additional studies suggest that RX-5902 is effective in drug-resistant cancer cells and is synergistic when combined with current cancer drugs.”
Novavax reported that its vaccine candidate to prevent a respiratory disease showed promise in a recent phase 1 clinical trial.
The experimental nanoparticle vaccine for respiratory syncytial virus was well-tolerated and highly immogenic, and produced antibodies that neutralized the virus, Gregory Glenn, senior vice president and chief medical officer of the Rockville biotech, announced at a vaccine conference in Copenhagen, Denmark.
There is no vaccine to prevent the disease, which is the main cause of bronchiolitis and pneumonia in infants younger than 1 and a leading cause of pneumonia in older adults. MedImmune of Gaithersburg markets a monoclonal antibody, Synagis, which can help prevent the infection in children.
A subsidiary of Sucampo Pharmaceuticals has won government approval in Japan to market Amitiza, its treatment for chronic constipation, except when caused by organic diseases, the Bethesda drug-maker announced.
“We are very pleased to receive Japan’s first-ever approval for a prescription medicine for chronic constipation as it helps us achieve our objective of bringing medicines with novel mechanisms of action to patients with unmet medical needs on a global basis,” CEO and Chairman Ryuji Ueno said in a statement.
Under a 2009 agreement, Sucampo and Abbott Japan will commercialize and supply the drug in Japan.