biotime inc (BTX) Key Developments
BioTime, Inc. and OncoCyte Corporation Announces Initial Data from Ongoing Clinical Study of Collagen Type X as A Marker and Potential Diagnostic for Breast Cancer and Other Types of Human Cancers
Apr 20 15
BioTime, Inc. and OncoCyte Corporation announced initial data from a large, prospective clinical study that showed the potential of PanC-Dx™, OncoCyte’s non-invasive diagnostic technology based on its proprietary set of cancer markers, as a non-invasive, blood-based diagnostic test to screen for multiple types of human cancers, including breast cancer. The early data showed the utility of the protein Collagen Type X (COL10A1) in distinguishing patients with malignant breast lesions from those with negative findings. The controlled study, initiated at Scottsdale Medical Imaging Laboratories in Scottsdale, AZ, is ongoing and has nearly completed enrollment of over 600 patients. The goal of this study is to assess the performance of PanC-Dx™ in discriminating patients with malignant breast lesions from those with negative findings or benign findings. Study investigators are collecting blood samples from patients undergoing screening or diagnostic mammography. Patient blood samples are being assessed for levels of OncoCyte’s PanC-Dx™ markers, including the concentration of the protein COL10A1, using proprietary assays and the results are compared to radiological and pathology findings. Expression of the gene COL10A1 at an mRNA level has been shown in past studies to be significantly elevated in multiple and diverse malignant tumor types including cancers of the breast, stomach, colon, lung, bladder, pancreas, and ovaries. In addition, the protein was shown to be specifically localized within tumor vasculature. Early data showed that PanC-Dx™ identified a mean concentration of COL10A1 protein in sera of breast cancer patients (n=33) that was 35% higher than the mean COL10A1 value in sera of normal individuals (n=32). No significant differences were noted when comparing breast cancer patients to patients with confirmed benign disease suggesting that additional biomarkers may be necessary to discriminate these two populations. Based on this data, PanC-Dx™ offered improved performance as compared to the commercially available enzyme-linked immunosorbent assay (ELISA) manufactured with polyclonal antibodies that study investigators previously used in analyzing over 400 serum samples from healthy volunteers and cancer patients. Evaluation of the performance of PanC-Dx™ demonstrated 86% area-under-the-curve (AUC) of the Receiver Operating Characteristic (ROC) curve, which determines the level of specificity and sensitivity of the product. The polyclonal ELISA demonstrated 74% AUC of the ROC curve.
BioTime, Inc. and Oncocyte Corporation Announce Positive Clinical Results of Panc-Dx, Oncocyte’s Class of Proprietary, Non-Invasive Cancer Diagnostic Tests, in Detecting the Most Common Type of Bladder Cancer, Urothelial Carcinoma
Apr 20 15
BioTime, Inc. and its subsidiary OncoCyte Corporation announced positive clinical results of PanC-Dx, OncoCyte’s class of proprietary, non-invasive cancer diagnostic tests, in detecting the most common type of bladder cancer, urothelial carcinoma. The first clinical study was conducted by OncoCyte in collaboration with investigators in the Department of Pathology at Johns Hopkins University School of Medicine led by Matthew T. Olson, M.D., Assistant Professor and Associate Director of the Division of Cytopathology in the Department of Pathology at Johns Hopkins University School of Medicine and principal investigator of the trial, and Dorothy Rosenthal, M.D., Professor of Pathology, Oncology and Gynecology/Obstetrics at Johns Hopkins University School of Medicine and collaborator on the study. Clinical investigation involved collection of 90 urine samples from patients undergoing urine cytology for the diagnosis of either primary or recurrent bladder cancer. Patient urine samples were assessed microscopically for the presence of cancer cells using the current standard-of-care method of cytopathology; in parallel, study investigators analyzed the urine samples for gene expression. Study investigators then investigated the performance the 43-marker panel derived from the first clinical study using a set of 195 urine samples obtained from a second, large ongoing clinical study at multiple urology clinics in the United States. Investigators in the trial are collecting urine samples from patients undergoing cystoscopy for the diagnosis of either primary or recurrent bladder cancer.
BioTime, Inc. Reports Unaudited Consolidated Financial Results for the Fourth Quarter and Year Ended December 31, 2014
Mar 11 15
BioTime, Inc. reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2014. For the quarter, the company’s total revenues were $1,887,535 against $1,892,485 a year ago. Loss from operations was $14,404,591 against $29,293,443 a year ago. Loss before income tax benefits was $14,976,252 against $29,335,719 a year ago. Net loss attributable to the company was $10,567,537 against $19,612,314 a year ago. Net loss attributable to the company's common shareholders was $10,620,326 against $19,612,314 a year ago. Basic and diluted net loss per common share was $0.14 against $0.35 a year ago. The decrease in net loss is primarily attributed to the $17,500,000 of IPR&D expense incurred during 2013.
For the year, the company reported total revenue was $5,243,204 against $4,434,336 a year ago. Loss from operations was $50,682,574 against $55,985,186 a year ago. Loss before income tax benefits was $51,154,711 against $56,189,821 a year ago. Net loss attributable to the company was $36,411,660 against $43,882,835 a year ago. Net loss attributable to the company's common shareholders was $36,498,487 against $43,882,835 a year ago. Basic and diluted net loss per common share was $0.55 against $0.81 a year ago. The increase in revenue is primarily attributable to an increase in grant revenue, partially offset by a decrease in license fees. The decrease in net loss is primarily attributable to the $17.5 million of IPR&D expense incurred during 2013. Net loss attributable to the company includes losses from the company’s majority owned subsidiaries based upon the company percentage ownership of those subsidiaries.
BioTime Seeks Acquisitions
Feb 2 15
BioTime, Inc. (AMEX:BTX) has filed a shelf registration in the amount of $100 million. BioTime said, "We intend to use the net proceeds from the sale of our securities offered by this prospectus for general corporate purposes, including, without limitation, working capital, capital expenditures, research and development expenditures, regulatory affairs expenditures, clinical trial expenditures, acquisitions of new technologies and businesses, and investments, including in our subsidiaries."
Aditya Mohanty Joins BioTime, Inc. as New Chief Operating Officer
Dec 29 14
On December 29, 2014, Aditya Mohanty joined BioTime, Inc. as its new Chief Operating Officer. Mr. Mohanty comes to the company from Shire plc, where he served in a number of executive positions, including as President/Head Regenerative Medicine from 2013 to 2014, as Senior Vice President, Business and Technical Operations from 2012 to 2013, as Global Franchise Head MPS from 2010 to 2012, and as Vice President of Operations/Product General Manager from 2005 to 2012. Mr. Mohanty was VP of Manufacturing and Operations at Transkaryotic Therapies, Inc. from 2002 to 2005 when it was acquired by Shire. Before joining Transkaryotic Therapies, Mr. Mohanty held a number of management positions at Baxter Healthcare Corporation, Bioscience
Division from 1990 to 2002.