A Medical Device Daily

Hadasit Bio-Holdings (HBL; Jerusalem, Israel), a subsidiary of Hadasit, the technology transfer company of the Hadassah-Hebrew University Medical Center, reported that one of its portfolio companies, Verto (in which it has a 75% stake), has completed a human clinical trial of a device for treating patients who suffer from systemic lupus erythematosus.

The goals of the trial at the Hadassah Medical Center (Ein Kerem, Israel) in which 10 lupus patients took part were to demonstrate the safety and efficacy of the Lupusorb, developed by Verto. The treatment was successful and achieved the goals.

Verto, established to commercialize the research of Professor Yaakov Naparstek, the head of the department of internal medicine at the Hadassah Hospital in Ein Kerem, is developing the Lupusorb for the treatment of systemic lupus erythematosus.

The device is a filter column that can be incorporated into the standard process of plasmapheresis, in which the blood is removed from the patient's body, cleansed of immune-system compounds, and returned to the body, for lupus patients.

The column contains a peptide (short protein), designated VRT101, which specifically binds a subgroup of auto-antibodies that the body has developed against itself, and which cause the disease. At the end of the process the blood is returned to the body with all the vital components intact, except for the auto-antibodies, which have been bound to the peptide in the column.

During the trial, 10 patients underwent plasmapheresis. Over the next two months they came in for regular check-ups, which included blood and urine tests and medical examinations.

The results indicated a statistically significant decrease in the level of disease-related antibodies in the patients' blood (anti-VRT). The antibody level remained low for three weeks and only than returned to its pre-treatment levels (increased four weeks into the trial) but there was no rebound effect (in which the antibody level exceeds that before treatment), as is usually found in routine plasmapheresis.

Improvement also was seen in other components of the immune system that bolster the body's resistance to the disease. No significant harmful side-effects associated with use of the device were observed.

Ophir Shahaf, CEO of Hadasit Bio-Holdings, said, "We are proud of the results of the trial, which represent a breakthrough in the treatment of lupus, given that until now there has been no treatment specific to the disease and the standard approach has been based on the use of steroids and chemotherapy that suppresses the immune system, with severe side-effects. Lupusorb has been found safe and effective in removing harmful antibodies from patients. The decline in the plasma antibody level is statistically significant after the first week and at week three."

He added, "Based on these encouraging results, we have scheduled a series of meetings with potential strategic partners who can cooperate with us in developing the device. As a medical device, it is attractive with regard to the odds for quick regulatory approval to market."

ColonSentry launched in Canada

GeneNews (Richmond Hill, Ontario), focused on developing blood-based biomarker tests for the early detection of diseases and personalized health management, reported the launch of ColonSentry, billing it as the world's first blood-based molecular test for colorectal cancer screening.

ColonSentry assesses a patient's current risk of having colorectal cancer, identifying those in the asymptomatic general population with increased risk who might benefit from further more invasive diagnostic testing such as colonoscopy.

The company said this risk stratification approach allows for a more targeted application of colonoscopy, which could increase the detection rate of colorectal cancer by as much as threefold in the general population.

The test requires a simple blood sample. The mRNA expression of a panel of seven specific genes is measured at the molecular level by quantitative RT-PCR, which results in an assessment of the patient's current risk.

ColonSentry will be performed at the company's laboratory facilities in Richmond Hill, and the company said it is the first in a series of blood-based molecular tests based on its platform technology, the Sentinel Principle.

"Each year thousands of Canadians die from colorectal cancer, the No. 2 cause of death among all cancers in both men and women. This is a tragedy because colorectal cancer is a preventable and curable disease, but only when detected early," said Lawrence Cohen, MD, director of gastroenterology at Sunnybrook Health Sciences Center and associate professor of medicine at the University of Toronto.

"The launch of ColonSentry represents a leap forward in the way we currently screen for colorectal cancer," he said. "By using this risk assessment tool as the first step in a regular screening program, information obtained with ColonSentry will result in better decision-making by doctors and their patients regarding next steps in the colorectal cancer screening process."

Barry Stein, president of the Colorectal Cancer Association of Canada, said, "A patient-friendly blood test like ColonSentry ... can certainly contribute to increased compliance with screening programs. This will facilitate earlier detection and treatment of the disease, resulting in improved outcomes for patients with colorectal cancer."

Singapore lab opened by AMRI

AMRI (Albany Molecular Research; Albany, New York) reported the opening of its first in vitro biology laboratory in Singapore and also the completion of a 10,000-square-foot laboratory expansion for medicinal chemistry discovery services, more than doubling the capacity of its Science Park III facility.

AMRI said that the establishment of in vitro biology testing services, coupled with expanded chemistry capabilities, increases its ability to execute integrated drug discovery projects of increasing complexity with reduced cycle time. The in vitro biology group will test compounds synthesized by AMRI's Singapore-based medicinal chemistry teams to deliver high-quality potency data using cell-based or biochemical assays.

"This expansion continues AMRI's investment in building out a worldwide drug discovery and development platform. Along with parallel investments in the U.S., India and Hungary, AMRI's global footprint is gaining a critical mass," said Thomas D'Ambra, PhD, president/CEO and chairman of the company.