On Monday, Great Basin Scientific, Inc. (NASDAQ:GBSN)’s shares surged 42.52% to $4.19, after a molecular diagnostic testing company, declared continued growth in the number of customers using its sample-to-result molecular diagnostic technology during the first quarter of 2015. The Company stated a total of 101 proceed-generating customers in the United States as of March 31, 2015, a 20% raise over the 84 customers stated as of the preceding quarter ending December 31, 2014. Customer evaluations, which represent the Company’s sales pipeline, have seen a matched raise of 20% over the fourth quarter of 2014 from 43 active and planned evaluations to 52 at the end of the first quarter of 2015.
“We are happy with our momentum in converting evaluation sites into Great Basin customers,” said Ryan Ashton, President and Chief Executive Officer of Great Basin Scientific. “We believe the solution we offer appeals to lab directors and technicians both for the system’s ease of use and our business model which, by placing the analyzer at no cost, allows a lab to adopt molecular diagnostic testing without any capital expenditure. We’re confident these underserved small-to medium-sized hospital labs will further embrace our unique product offering, and we look forward to building on this success throughout 2015. We are executing firmly against our plan to have 170 to 180 U.S. proceed-generating customers by the end of the year and another 40 to 45 sites in active and planned evaluations.”
Great Basin Scientific, Inc., a molecular diagnostic testing company, doing business as Great Basin Corporation, develops and commercializes molecular diagnostic systems that are designed to test hospital-attained infections. The company’s platform provides C. diff test, a rapid medical diagnostic test for the detection of C. diff, a gram-positive bacteria that causes severe diarrhea and other intestinal disorders.
Clovis Oncology, Inc. (NASDAQ:CLVS)’s shares gained 13.04% to $87.49, during the last trading session on Monday, hitting its highest level, as on April 6, a biopharmaceutical company, declared that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of preceding platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations.
Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 being developed for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, ordinarily referred to as “BRCA-like” or “BRCAness.” The Breakthrough Therapy designation was granted based on interim efficacy and safety results from two ongoing Phase 2 studies of rucaparib in ovarian cancer, counting a Phase 2 study in women with gBRCA mutations, and the ARIEL2 treatment study.
A clinical data update from the ARIEL2 study presented last week at the 2015 Annual Meeting on Women’s Cancer® demonstrated that seventy percent (16/23) of evaluable BRCA-mutant patients achieved a RECIST and/or CA-125 response, and 65% (15/23) achieved a RECIST response. Responses were observed in both germline and somatic BRCA-mutant tumors.
A clinical data update from the ARIEL2 study presented last week at the 2015 Annual Meeting on Women’s Cancer® demonstrates encouraging activity and safety in women with advanced, platinum-sensitive ovarian cancer with gBRCA and sBRCA mutations. Seventy percent (16/23) of evaluable BRCA-mutant patients achieved a RECIST and/or CA-125 response, and 65% (15/23) achieved a RECIST response. Responses were observed in both germline and somatic BRCA-mutant tumors. In addition, data presented last week further demonstrate that Clovis’ proprietary BRCA-like DNA signature, run by its partner Foundation Medicine, successfully predicts which ovarian cancer patients respond to rucaparib therapy. In patients with normal BRCA genes, rucaparib activity was substantially higher for those with the prospectively-defined BRCA-like HRD signature as compared to biomarker negative patients. Forty-eight percent (12/25) of patients with the BRCA-like signature achieved a RECIST and/or CA-125 response, and 40% (10/25) achieved a RECIST response. In biomarker negative patients, few responses were observed: eight percent (1/13) of patients achieved a RECIST and/or CA-125 response.
These data also demonstrate that rucaparib is well-tolerated. At the recommended Phase Two dose of 600mg BID, the most ordinary treatment-related adverse events (AEs) stated in ≥15 percent of all patients (n=121) comprised of nausea, fatigue, transient ALT/AST elevations, dysgeusia, constipation, anemia/low hemoglobin, reduced appetite, vomiting and diarrhea. These events were mostly Grade 1/2; the only ordinary grade 3/4 toxicity was anemia/low hemoglobin.
The next update of rucaparib clinical data, counting outcomes data on the complete Part One ARIEL2 patient population, will be presented in an oral presentation at the 2015 American Society of Clinical Oncology Annual Meeting in late May/early June.
Clovis Oncology, Inc., a biopharmaceutical company, focuses on acquiring, developing, and commercializing anti-cancer agents in the United States, Europe, and internationally. It is developing three product candidates which comprise Rociletinib, an oral epidermal growth factor receptor and mutant-selective covalent inhibitor that is in advanced clinical development for the treatment of non-small cell lung cancer.
At the end of Monday’s trade, Oramed Pharmaceuticals Inc. (NASDAQ:ORMP)’s shares surged 38.68% to $8.64, as on April 1, a clinical-stage pharmaceutical company declared the first patient has been enrolled in its Glucose Clamp Study. The study will be performed at The University of Texas Health Science Center at San Antonio and University Health System’s Texas Diabetes Institute under the supervision of Professor Ralph DeFronzo.
The glucose clamp is a method for quantifying insulin absorption in order to measure a patient’s insulin sensitivity and how well a patient metabolizes glucose. The glucose clamp technique represents the gold standard for pharmacodynamic studies in diabetes drug development.
In addition to the clamp study, Oramed plans to initiate its Phase IIb oral insulin trial in the U.S. with a protocol which comprises over 30 U.S. sites covering about 180 patients and has both efficacy and safety as its primary end-points.
“We are happy to have initiated this study and enrolled the first patient. We are additionally excited at the prospects of starting our larger Phase IIb trial in the near term. The data from the two trials will allow for a clearer picture of our oral insulin and its pharmacological characteristics as we move forward with our development plan,” stated Oramed CEO Nadav Kidron.
Oramed Pharmaceuticals Inc. engages in the research and development of pharmaceutical solutions for the use of orally ingestible capsules or pills for delivery of polypeptides. Its product portfolio comprises ORMD-0801, an oral insulin capsule that accomplished Phase IIa clinical trials for the treatment of diabetes; and ORMD-0901, an analog for GLP-1 gastrointestinal hormone, which is in pre-clinical trials for the treatment of type 2 diabetes.
Finally, ARCA biopharma, Inc. (NASDAQ:ABIO), ended its Monday’s trading session with 13.35% gain, and closed at $0.95, after a biopharmaceutical company, declared that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of GencaroTM for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction, HFREF). Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator.
According to the FDA’s Fast Track Guidance document, Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Gencaro is presently being evaluated as a potential treatment for atrial fibrillation in a genetically-defined heart failure (HFREF) population in GENETIC-AF, a Phase 2B/3 adaptive design clinical trial. ARCA anticipates that enrollment of about 200 patients in the Phase 2B portion of the trial will be accomplished by the end of 2016.
ARCA biopharma, Inc., a biopharmaceutical company, focuses on developing genetically-targeted therapies for cardiovascular diseases. Its lead product candidate is Gencaro, a pharmacologically unique beta-blocker and mild vasodilator for the treatment of atrial fibrillation in patients with heart failure and left ventricular dysfunction. ARCA biopharma, Inc. is headquartered in Westminster, Colorado.
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