Archive: Company News
Company News: Legacy Healthcare Announces Breakthrough Clinical Results in Hair Re-growth
– CG210™ improves hair thickness in patients using finasteride –
Legacy Healthcare, a company developing innovative products for hair and scalp disorders with a special focus on oncology supportive care, today announced clinical results of a double-blind, placebo-controlled, long-term trial of its innovative CG210™ topical treatment in patients suffering from hair loss.
The primary endpoint of the 12-month clinical study in subjects already using finasteride 1mg as a treatment for hair loss was the increase of mean diameter of hair. Participants received topical CG210™ or topical placebo in addition to the oral finasteride 1mg they were already taking. Finasteride, a synthetic type-2 5α-reductase inhibitor, has been approved by the US FDA, among others, for the treatment of male pattern baldness (MPB). As of September 27, 2012, results from 16 volunteers, who completed a 12 month cycle, were analyzed. The mean diameter of hair of subjects receiving topical CG210 increased 36.9% more than the mean diameter of hair of subjects receiving topical placebo (p<0,0001). The study was conducted in Japan.
Company News: VAXIMM Completes Enrollment of First Oral Cancer Vaccine Trial
VAXIMM AG, a Swiss-German biotech company focusing on oral cancer vaccines, announced today that it completed enrollment in the first clinical trial of its investigational oral therapeutic cancer vaccine VXM01. The randomized, placebo-controlled, double-blind Phase I/II dose escalation study enrolled 45 patients with inoperable pancreatic cancer at the Heidelberg University Hospital (Heidelberg, Germany). In addition to standard-of-care treatment, the patients received several doses of VXM01, a therapeutic cancer vaccine targeting the tumor vasculature. The results of the first, blinded part of the study are expected in the first quarter of 2013.
The investigational therapeutic vaccine VXM01 is designed to stimulate the patients’ own immune system to destroy tumor-associated blood vessels. It is the first therapeutic cancer vaccine in clinical development that does not target the cancer cells directly. Instead, it addresses the tumor stroma, a structure essential for growth and metastasis formation of solid tumors. VXM01 is also the first investigational therapeutic cancer vaccine which is administered orally and which acts in the gut to induce an anti-tumor response of the immune system.
Company News: Curetis Completes Enrollment for its EU Trial As Planned
– Prospective multi-center trial enrolls 800 patient samples in 7 months-
Curetis AG today announced it has completed enrollment for the European clinical trial of its Unyvero™ Pneumonia Application on schedule. More than 800 patient samples were collected until September 30, 2012. Data analysis will be completed in early 2013. Subsequently, results will be published in a major, peer-reviewed journal.
The trial will compare the performance of the Unyvero™ P50 Pneumonia Cartridge with conventional microbiology culture, the current standard of care. Primary endpoint will be clinical sensitivity and specificity for the identification of 17 pathogens covered by the Unyvero™ P50 panel. Secondary endpoints include time to result and correlation of resistance marker detection with phenotypic antibiograms. Curetis will conduct systematic discrepant results resolution by PCR and sequencing to confirm the clinical truth in samples where Unyvero results differ from microbiology culture.
The study complements the previously completed CE performance evaluation study, in which the Unyvero P50 Cartridge identified a significant number of additional pathogens not detected by microbiology culture. These findings were confirmed by PCR analysis.
Company News: Merus Announces the Full Validation of Its MeMo® Transgenic Mouse for Common Light Chain Human Antibodies
Merus B.V., a biopharmaceutical company focused on innovative human antibody therapeutics, announced today the full validation of its transgenic MeMo® mouse for common light chain human antibodies. The MeMo® mouse creates human antibody diversity using a large repertoire of human heavy chains paired with a common human light chain.
“Over the last year, we have immunized MeMo® mice with half a dozen antigens and analyzed the immune response,” said Mark Throsby, COO at Merus. “We are extremely excited by the performance of the MeMo® technology; serum antibody titers as well as size, diversity, functionality and developability of antibody panels are comparable to those of wild type mice.”
“In MeMo®, a single human light chain drives the generation of a normal B cell compartment as well as supports a robust immune response,” said Ton Logtenberg, CEO and founder of Merus. “The large and diverse panels of high-quality human antibodies that we retrieve from MeMo® show that this platform is comparable to the best-in-class transgenic platforms using diversified heavy and light chains.”
Because of the common light chain, MeMo®-derived antibodies can be immediately used to rapidly generate thousands of bispecific antibodies (Biclonics™) and combinations of antibodies (Oligoclonics®) for functional screening. Merus has shown that the quality and diversity of common light chain antibodies drives the success of identifying Biclonics™ with unprecedented potencies for application in oncology. The MeMo® mouse is available for licensing.