|Biocept Launches Lung Cancer Offering; Ocular Enrolls First Patients in Phase 2b Clinical Trial for Travoprost|
|By Josh Gee|
|Wednesday, 12 November 2014 19:38|
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA and Circulating Tumor Cells (CTCs), today announced the launch of its lung cancer liquid biopsy testing that will be performed at the Company's CLIA-certified and CAP-accredited laboratory.
By launching blood-based biomarker testing for non-small cell lung cancer (NSCLC), along with the previously commercialized breast cancer offering, Biocept is providing options for health care providers and researchers when a tumor biopsy is not available, is unsafe to perform or when additional information is desired. For patients with recurrent or newly diagnosed metastatic lung cancer, accurate identification of genomic biomarker information is a key piece of information that clinicians need when making treatment decisions. A challenge for physicians has been availability of tissue from the surgical biopsy that is required to perform the biomarker testing. This limitation occurs as a result of tumor location or health of the patient. According to a recent study1, when lung biopsies are attempted, there is a 19.3% risk of complication such as a collapsed lung or an infection. Managing these complications quadruples the cost of care. In comparison, the cost of a simple blood draw is nominal, and poses little risk for patients, and the Company believes it has the potential to simultaneously save cost and improve outcomes for the health care system.
The Company's first CLIA-validated assay for lung cancer will be testing for ALK fusions on CTCs captured in Biocept's patented device. ALK is incorporated into the testing guidelines utilized by oncologists when making treatment decisions in NSCLC patients. ALK positive patients now have targeted treatment options with two key drugs that have been approved by the FDA: the first is Pfizer's Xalkori (Crizotinib) and the second is Novartis's Zykadia (ceritinib), and others are in development.
"The evaluation of biomarker status is the standard-of-care in determining the course of therapy for patients with lung cancer," said Michael Nall, President and CEO of Biocept. "We are excited to be able to help physicians by providing actionable genomic information for lung cancer patients with a simple blood test."
"A liquid biopsy, or blood based genomic test, has the advantage of being far less invasive than a surgical biopsy, therefore being appropriate for diagnostic and importantly, monitoring purposes. This gives physicians insight into the molecular status of the patient in real time so that therapeutic changes can be made for better patient outcomes," says Lyle Arnold, SVP and Chief Scientific Officer of Biocept.
The Company currently plans to offer additional biomarkers for lung cancer that physicians use when making treatment decisions before the end of the year and during 2015, including EGFR mutations, Ros1 fusions, KRAS mutations, and EGFR and MET amplification. EGFR mutation status, like ALK, is a biomarker included in guidelines that oncologists follow to determine the best treatment plan for a patient. Patients who have EGFR mutations are eligible for Tyrosine Kinase Inhibitors such as TarcevaR from Genentech or IressaR from AstraZeneca. In addition, the Company is validating important resistance markers for these targeted therapies that they expect to be used most often when physicians are monitoring patients.
Biocept expects that some of these biomarkers will be performed on CTCs while others will be performed on circulating cell free DNA, which, if successful, has the potential to make Biocept one of the first to offer genomic analysis both on intact cells and plasma.
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, announced enrollment of the first patients in a Phase 2b clinical trial evaluating Sustained Release Travoprost (OTX-TP) for the reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension. OTX-TP is administered by a physician as an insert into the punctum, a natural opening in the eyelid near the tear ducts, designed to deliver travoprost to the ocular surface for up to 90 days.
The prospective, multicenter, randomized, double-masked, parallel-arm, active controlled study is designed to evaluate 80 patients at 10 clinical sites for the safety and efficacy of the OTX-TP as compared to timolol. Study efficacy endpoints include difference in the mean intraocular pressure change between the treatment groups from baseline at multiple timepoints throughout the study.
Previous pilot and Phase 2a clinical trials evaluating OTX-TP showed robust reductions in intraocular pressure for up to three months, similar to results found with twice-daily timolol dosing. No serious adverse events occurred, including no increases in hyperemia, and patients were comfortable with use of the plug overall. “It is our hope that OTX-TP will have a significant impact in helping to fight one of the leading causes of blindness in the world,” stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc.
Glaucoma and ocular hypertension are chronic, sight-threatening diseases caused by elevated intraocular pressure, which affects approximately 2.7 million people in the United States alone, which resulted in 31 million prescriptions and sales over $2.1 billion in 2013.1,2 Many of those afflicted with the disease have difficulty complying with the required dosing regimen or being able to self-administer eye drops, which is especially troublesome as patients get older. “Many patients do not adhere to dosing regimens, which can quickly lead to vision problems. Sustained release glaucoma therapy helps eliminate the burden placed on patients for daily administration of eye drops,” stated Steven D. Vold, M.D., Founder and CEO of Vold Vision in Fayetteville, Arkansas, a Principal Investigator on the trial.
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), announces that the external Data and Safety Monitoring Board (DSMB) has recommended the continuation of its phase 2 study of masitinib in advanced hepatocellular carcinoma based upon review of the latest safety and efficacy data.
ActiveCare Inc. (OTCBB:ACAR), a provider of diabetes management and wellness services for self-insured employers nationwide, today reported restated financial results for the fiscal year ended September 30, 2013 and the quarterly periods ended December 31, 2013, March 31, 2014 and 2013, and June 30, 2014 and 2013.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the Company has submitted an Investigational New Drug application (IND) to the United States Food and Drug Administration (FDA) to conduct a Phase 1/2 study of ADXS-HPV (ADXS11-001) alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) announced today that it has completed the acquisition of Lumara Health Inc., a specialty pharmaceutical company with a particular focus on maternal health.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform, today announced that Jeff Abbey, president and chief executive officer, will present at the Stifel 2014 Healthcare Conference on Tuesday, November 18th, 2014 at 3:00 p.m. Eastern Time.
Avalanche Biotechnologies, Inc. (Nasdaq:AAVL), a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today reported financial results and operational highlights for the quarter ended September 30, 2014.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today that it will present on its next generation sequencing (NGS) panels for hematological malignancies at the Association for Molecular Pathology's (AMP) 2014 Annual Meeting in Harbor, MD. Principal clinical scientist Charles Ma, Ph.D., will present "Developing NGS-based Clinical Assays for Hematological Neoplasms at CGI" on Wednesday, November 12 at 3 p.m. EST.
Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today provided a business and financial update for the third quarter ended September 30, 2014.
Cellular Dynamics International, Inc. (Nasdaq:ICEL), today announced that Susan A. Willetts was elected to the company's board of directors, effective November 6, 2014.
Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated medical dermatology products to dermatologists and their patients, today reported financial results for the quarter ended September 30, 2014.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the limited market release of a new orthobiologic implant.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CAPRI™ Corpectomy Cage System, an expandable vertebral body replacement device that provides structural stability following a corpectomy or vertebrectomy.
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that it will be participating in three upcoming investor conferences in New York City in November.
Lion Biotechnologies, Inc. (OTCBB:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TILs), today announced that its chief executive officer Manish Singh, PhD, is resigning for personal reasons, effective December 31, 2014.
Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), an emerging biopharmaceutical company focused on the development and commercialization of omega-3 fatty acid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions, today announced it has commenced dosing in the first-in-human study of MAT9001.
Medgenics, Inc. (NYSE MKT:MDGN) today announced a major research collaboration with The Children's Hospital of Philadelphia (CHOP) focused on pediatric rare and orphan genetic diseases.
MELA Sciences, Inc. (Nasdaq:MELA), developer of the MelaFind® system, a non-invasive software-driven image analysis device intended to provide a dermatologist with objective data of clinically irregular pigmented moles when they choose to obtain additional info to help them decide whether or not to biopsy (at the most curable and cost-effective stage), today announced financial results for the three and nine months ended September 30, 2014.
Nature's Sunshine Products, Inc. (Nasdaq:NATR), a leading natural health and wellness company, today announced that it will be holding a special meeting of shareholders on Wednesday, January 14, 2015, at the Company's principal executive offices located at 2500 West Executive Parkway, Suite 100, Lehi, Utah 84043.
NeoStem, Inc. (Nasdaq:NBS), a biopharmaceutical company developing novel cell based therapeutics, announced today that the Company will present at multiple upcoming investor conferences in late November in addition to its presentation at the American Heart Association Scientific Sessions of data from the Phase 2 PreSERVE AMI clinical trial evaluating NBS10 in the treatment of damaged heart muscle following a heart attack.
Oncothyreon Inc. (Nasdaq:ONTY) announced today that Robert Kirkman, M.D., President and Chief Executive Officer, will present at the Stifel 2014 Healthcare Conference in New York on Wednesday, Nov. 19, 2014 at 3:00 p.m. Eastern.
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today reported financial results for the third quarter ended September 30, 2014.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, reported financial results for the quarter ended September 30, 2014.
Pacific Health Care Organization, Inc., (OTCQB: PFHO) today filed with the Securities and Exchange Commission its quarterly report on Form 10-Q announcing its financial results for the periods ended September 30, 2014.
Parnell Pharmaceuticals Holdings Ltd (Nasdaq:PARN), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions, today announced that Robert Joseph, President and Chief Executive Officer, will present at two upcoming investor conferences: Jefferies 2014 Global London Healthcare Conference--Waldorf Hilton, London--Wednesday, November 19, 2014, 3:40 PM GMT--Track 4: Executive Boardroom; 26th Annual Piper Jaffray Healthcare Conference--The New York Palace--Wednesday, December 3, 2014, 3:30 PM EST.
Premier, Inc. (Nasdaq:PINC) today launched an underwritten public offering of 3,709,394 shares of Class A common stock on behalf of certain selling member-owner stockholders who elected to participate in Premier's October 31, 2014 share exchange process, as contemplated by a registration rights agreement executed in connection with Premier's initial public offering.
RedChip Companies, Inc., today announced it has issued a research note on Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics that personalizes the clinical management of difficult-to-diagnose cancers.
Revance Therapeutics, Inc. (Nasdaq:RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today reported financial results for the three and nine months ended September 30, 2014.
SANUWAVE Health, Inc. (OTCQB:SNWV) today reported financial results for the three and nine months ended September 30, 2014 and provided a business update.
Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, in addition to announcing details of its Q3, 2014 Conference Call, is proud to announce the promotion of David Spencer to the position of President of its Quad Video HALO subsidiary.
Surgical Care Affiliates, Inc. (Nasdaq:SCAI) today announced financial results for the third quarter ended September 30, 2014.
TESARO, Inc. (Nasdaq:TSRO) announced today that Lonnie Moulder, CEO of TESARO, will present at the Jefferies 2014 Global Healthcare Conference on Wednesday, November 19, 2014 at 11:20 a.m. GMT in London.
Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE), a clinical-stage biotechnology company, today announced that Jeffrey Hatfield, President and Chief Executive Officer, will present a company overview at the Stifel 2014 Healthcare Conference on Wednesday, November 19, 2014 at 4:45 p.m. EST in New York City.
Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE), a clinical-stage biotechnology company, reported today its operating and financial results for the third quarter ended September 30, 2014.