Rexahn Pharmaceuticals' candidate to treat pancreatic cancer has shown promising results in a phase 2 clinical study.
Archexin, when given in combination with a standard chemotherapy drug, gemcitabine, kept patients alive for a median 9.1 months, versus 5.65 months in historical survival data for gemcitabine alone, the Rockville biotech reported.
The company's stock initially shot up 34 percent on the news Tuesday.
The study involved 31 patients, ages 18 to 65, at four sites in the U.S. and five in India. The trial's primary endpoint was overall survival following four cycles of therapy with a six-month follow-up.
"With this supportive clinical outcome data, we look forward to progressing the clinical development of this exciting compound,” CEO Chang Ahn said in a statement.
The results indicate that Archexin, given with gemcitabine, "may be another treatment option for this difficult to treat cancer,” Troy Guthrie of Baptist Medical Center in Jacksonville, Fla., and a trial investigator, said in the statement.
The Food and Drug Administration has designated Archexin as an orphan drug for five cancer types: renal cell carcinoma, glioblastoma, pancreatic, stomach and ovarian. As such, the drug is eligible for a seven-year period of market exclusivity upon FDA approval for treating any of these indications.
In other Maryland bioscience industry news:
Neuralstem is wrapping up its safety study of its stem cell treatment for amyotrophic lateral sclerosis at Emory University in Atlanta.
The Rockville biotech reported that the 18th patient in the phase 1 clinical trial has received spinal cord neural stem cells; he was the third patient in the study to return for more injections.
The trial is scheduled to conclude in six months.
"There have been many firsts in this trial, including the first lumbar intraspinal injections, the first cervical region intraspinal injections and the first cohort of patients to receive both," Jonathan D. Glass, director of the Emory ALS Center, said in a company statement.
"We have found the procedure to be extremely safe," Eva Feldman, the trial's principal investigator, said in the statement. "In some patients, it appears that the disease is no longer progressing, but it is too early to know if the result from that small number of patients is meaningful."
Feldman, an unpaid consultant to Neuralstem, is director of the A. Alfred Taubman Medical Research Institute and director of research of the ALS Clinic at the University of Michigan Health System.
Neuralstem's stock rose 11 percent on the news Monday.
The trial launched in January 2010 and was designed to enroll up to 18 patients. The first dozen patients received injections in the lower spine, starting with patients unable to walk and then those who could. Some patients later received injections in the upper spine.
Gliknik of Baltimore reported raising $4.8 million of a $15.0 million equity offering.
The biotech, with less than $1 million in annual revenues, according to its filing with the Securities and Exchange Commission, has two cancer therapies in clinical trials. It's also developing treatments for immune and inflammatory disorders.
In October, the company reported winning a Small Business Innovation Research grant of up to $1.5 million from the National Cancer Institute.
Mice with type 2 diabetes can help recover from peripheral neuropathy, a nerve disorder affecting the limbs, when treated with a Rockville biotech's novel compound.
RegeneRx Biopharmaceuticals reported that its thymosin beta 4 promotes such recovery, including neurovascular dysfunction in the sciatic nerve and recovery of neurological function. Peripheral neuropathy affects upward of 70 percent of diabetics.
The study was conducted by researchers at the Henry Ford Hospital in Detroit and Oakland University in Rochester, Mich. Results were published in Neurobiology of Disease.
RegeneRx is developing thymosin beta 4 for several conditions, including ophthalmic, cardiac and skin conditions.