A Baltimore biotech reported that its experimental HIV vaccine showed promising results in a phase 1 clinical study.
Profectus BioSciences tested its vaccine on 60 adults in Philadelphia, San Francisco, Nashville, Tenn., and Decatur, Ga., who were not infected by the virus that causes AIDS. It was safe at all dose levels and immunogenic — as it was in studies involving macaques.
"The demonstration that our ... vaccine delivery platform is safe and immunogenic in healthy adult volunteers is a milestone that allows Profectus to advance not only its HIV vaccine program, but also vaccines for multiple infectious disease indications," John Eldridge, the 9-year-old company's chief scientific officer, said in a statement. "The response rate observed in this clinical trial is absolutely consistent with our data in non-human primates."
The vaccine is based on the recombinant vesicular stomatitis virus vector. The RNA virus, which can infect both insects and mammals, is used in laboratories as a gene delivery vector without the potential for integration, which makes it safer for vaccine applications, according to company information. The recombinant version used in the trial can replicate in human cells, but has been weakened so it won't cause illness.
The National Institute of Allergy and Infectious Disease is supporting Profectus' vaccine development with a $22.5 million contract.
In other Maryland bioscience industry news:
Sucampo Pharmaceuticals has gotten the regulatory go-ahead to remove the warnings and precautions for pregnant and nursing women from the labels of its constipation drug, Amitiza.
The Bethesda company's product already received marketing approval from the Food and Drug Administration for treating chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in women 18 and older.
“We believe these changes will enable physicians and women of child-bearing age who are suffering from [constipation] to better evaluate the risk-benefit profile of Amitiza," CEO Ryuji Ueno said in a statement.
Sucampo also reported that the FDA postponed the goal date for its review of the company's application to market the drug for treating opioid-induced constipation in patients with chronic, non-cancer pain. Because new submitted information was deemed a major amendment to the application, that date has been pushed back three months, to late April. The FDA did not seek any new clinical trials or studies.
An experimental nanoparticle vaccine for respiratory syncytial virus developed by Novavax was safe and effective in a preclinical trial on animals. Results from the study were published online in the journal Plos One.
The data demonstrated the candidate's potential "to elicit the level and type of immunity required to protect humans as measured by virus neutralization activity," Gale Smith, vice president of vaccine development with the Rockville biotech, said in a statement.
Severe respiratory syncytial virus infections are the leading cause of infant hospitalization in the U.S., and globally there are 64 million cases and 160,000 deaths annually, according to Novavax. The infection also is especially dangerous among older populations, and there is no approved prophylactic vaccine.
"We have completed a phase 1 trial and recently initiated two separate dose-ranging clinical trials of the ... nanoparticle vaccine candidate in the elderly (phase 1) and in women of child-bearing age (phase 2)," Gregory Glenn, chief scientific officer, said in the statement. "These preclinical observations are consistent with the promising safety and immunogenicity seen in our clinical trials reported to date and suggest that this vaccine should continue to be developed."
The study report is online at plosone.org.
Cytomedix, with funding from the National Heart, Lung and Blood Institute, will conduct a phase 2 clinical study of its treatment for an ailment called intermittent claudication. It’s caused by peripheral arterial disease, which results in reduced flow of blood and oxygen to leg muscles. About 8 million to 10 million Americans have the disease, with many of them having intermittent claudifcation, which causes lower-leg pain when the patient is moving, according to company information.
The study will involve 80 patients, with some receiving a placebo and others receiving injections of stem cells isolated from their bone marrow using the Gaithersburg biotech’s Bright Cell technology. Enrollment is expected to begin in the first quarter of next year.
“Our February acquisition of Aldagen and the Bright Cell technology has positioned us well to play a leading role in investigating promising clinical paths in regenerative medicine where there exists significant unmet medical need,” CEO Martin P. Rosendale said in a statement. “Intermittent claudication is a serious consequence of arteriosclerosis which, if left untreated, will likely progress to pain at rest and possibly open wounds.”
Supernus Pharmaceuticals, which went public this year and later won FDA approval for its anti-epilepsy treatment, announced the pricing of its public offering of six million shares: $8 a share.
The Rockville company also is developing drugs to treat impulsive aggression in people with attention deficit hyperactivity disorder.
Rexahn Pharmaceuticals closed on its previously announced public offering, grossing $6.6 million, including a partial exercise of the over-allotment option by the underwriter.
The Rockville biotech focuses on developing treatments for cancer and central nervous system disorders.
EntreMed, another Rockville biotech that develops cancer treatments, announced the publication of preclinical results of its compound for multiple sclerosis.
The report on 2-methoxyestradiol was published online in this week's Early Edition of Proceedings of the National Academy of Sciences. The study was conducted at the Campbell Family Institute for Breast Cancer Research at Princess Margaret Hospital in Toronto.
"In this study, we demonstrated that 2ME2 ... significantly inhibits lymphocyte activation and proliferation and dramatically suppresses development of experimental MS," Tak W. Mak, director of the institute and leader of the study, said in a statement.
The compound "represents another important asset for our company with its strong [intellectual property] position and sound safety profile," EntreMed CEO Ken Ren said in the statement. "For the next step, we intend to further advance 2ME2 development as part of our global drug development plan and strategy to leverage resources both in the U.S. and China. We are currently exploring multiple strategies for the development of 2ME2 including possible partnership opportunities. We believe that the development of 2ME2 for autoimmune diseases fits well with our plan to build a robust product pipeline and to add value for our long term shareholders."
The article is online available at pnas.org.