Shares of Antares Pharma Inc (NASDAQ:ATRS) ended Wednesday session in green amid volatile trading. The shares closed up +0.02 points or 1.16% at $1.75 with 1.00 million shares getting traded. Post opening the session at $1.76, the shares hit an intraday low of $1.64 and an intraday high of $1.78 and the price vacillated in this range throughout the day. The company has a market cap of $284.51 million and the numbers of outstanding shares have been calculated to be 155.06 million shares.
Antares Pharma Inc (ATRS) on Sept. 22, 2016 announced safety results from the dose-blinded, multiple-dose, concentration-controlled, 26-week phase 3 study of QuickShot® Testosterone (QST) administered subcutaneously once each week to adult males with hypogonadism. The study, QST-15-005, included a screening phase, a titration phase and a treatment phase for evaluation of safety and tolerability, including laboratory assessments, adverse events and injection site assessments.
The safety population, defined as patients who received at least one dose of study drug, was comprised of 133 patients. The most common adverse reactions (incidence ≥5%) in this study were increased hematocrit, upper respiratory tract infection and injection site ecchymosis. There were four patients with treatment emergent serious adverse events (SAE’s), which included one patient with transient visual impairment determined not to be drug related, one patient with appendicitis that was not drug related and one patient with deep vein thrombosis (DVT). The investigator attributed DVT as possibly drug related, which is consistent with known testosterone class SAE’s. The fourth patient had multiple hospitalizations related to septic arthritis and coronary artery disease, with a complicated clinical course post-angioplasty. These multiple reported events from the fourth patient were deemed not to be drug related. There have been no reported adverse events consistent with urticaria (hives), POME or anaphylaxis. The safety data collected also included an assessment of pain. Of the 965 injections assessed, pain was reported one time. In that instance, the pain reported was classified as mild.
“We are extremely pleased with the 26-week safety data from study QST-15-005 as well as the previously announced safety data and pharmacokinetic results from study QST-13-003. Our goal has been to produce a safe, convenient and virtually painless treatment alternative to current topical and intramuscular therapies, potentially eliminating both transference issues associated with topical therapies and the peaks and troughs commonly observed with various injectable dosing regimens,” stated Robert F. Apple, President and Chief Executive Officer. “We believe that a once-weekly, subcutaneous dose of QST can restore and maintain steady state testosterone levels consistently, and that the conclusion of this supplemental safety study completes the clinical work necessary to begin the New Drug Application submission process. We will continue to work closely with the Food and Drug Administration toward a potential approval for this unique treatment for hypogonadism.”
Shares of Immunomedics, Inc. (NASDAQ:IMMU) ended Wednesday session in red amid volatile trading. The shares closed down -0.01 points or -0.29% at $3.39 with 1.04 million shares getting traded. Post opening the session at $3.39, the shares hit an intraday low of $3.06 and an intraday high of $3.43 and the price vacillated in this range throughout the day. The company has a market cap of $338.94 million and the numbers of outstanding shares have been calculated to be 95.87 million shares.
Immunomedics, Inc. (IMMU) on Aug. 18, 2016 announced that adding an inhibitor of ATP-binding cassette (ABC) transporters to sacituzumab govitecan, the Company’s lead antibody-drug conjugate (ADC) for solid cancer therapy, increased the median survival of mice bearing a SN-38-resistant human gastric cancer cell line. Results from this preclinical study were published in Molecular Cancer Therapeutics.
Sacituzumab govitecan is a first-in-class ADC developed by the Company by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to hRS7, a humanized antibody that targets the Trop-2 receptor expressed by many solid cancers. This ADC has produced promising therapeutic results in some patients with metastatic solid cancers in an open-label, single arm Phase 2 study. Based on results from this mid-stage trial, the FDA has granted sacituzumab govitecan Breakthrough Therapy designation for the treatment of patients with triple-negative breast cancer who have failed prior therapies for metastatic disease, and the Company is working with the regulatory agency toward a potential accelerated approval in this disease setting.
A common cause of treatment failure in cancer therapy is multidrug resistance. In general, the occurrence of drug resistance in cancer cells can be intrinsic or acquired, with each type resulting from a variety of factors, such as decreased uptake of soluble drugs, activation of drug-detoxifying systems, modulation or mutation of drug targets, defective apoptosis pathways, and, above all, overexpression of the ABC transporters, which act by expelling drugs from the cell, thereby lowering the amount of drugs inside the cancer cells.
The objective of this preclinical study was to explore the use of known inhibitors of ABC transporters for improving the therapeutic efficacy of sacituzumab govitecan by overcoming SN-38-resistance. Human breast and gastric cancer cell lines were first made resistant to SN-38 by continuously exposing them to increased concentrations of SN-38 over a period of approximately 2 years. The two SN-38-resistant cell lines were shown to be 50-fold less responsive to SN-38 than their parental cells.