|Onconova's ONTIME Trial of Rigosertib Did Not Meet its Primary Endpoint; Parametric Sound Receives FDA Clearance for HyperSound|
|By Staff and Wire Reports|
|Wednesday, 19 February 2014 20:28|
Onconova Therapeutics, Inc. (Nasdaq: ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, announced the Phase 3 ONTIME trial of intravenous (IV) rigosertib in patients with higher risk myelodysplastic syndromes (MDS) who had progressed on, failed or relapsed after prior therapy with hypomethylating agents (HMAs) did not meet the primary endpoint of overall survival compared to best supportive care (BSC). The ONTIME trial enrolled 299 patients including 199 patients in the IV rigosertib plus BSC arm. Median overall survival in the IV rigosertib plus BSC arm was 8.2 months compared to 5.8 months in BSC only arm. Treatment with IV rigosertib plus BSC did not demonstrate a statistically significant improvement in median overall survival when compared to BSC only (Hazard Ratio=0.86; p-value=0.27).
However, a post-hoc analysis demonstrated a statistically significant increase in median overall survival in the subset of patients who had progressed on or failed previous treatment with HMAs (i.e., had not responded to HMAs), thus demonstrating potential activity of rigosertib in these MDS patients. In this subset of patients (184 of 299 enrolled patients), the median overall survival was 8.5 months in the IV rigosertib plus BSC arm compared to 4.7 months in BSC only arm (Hazard Ratio=0.67; p-value=0.022). Among this patient population, 127 patients were in the treatment arm, and 57 patients were in the BSC arm. The other subset which was comprised of patients who had relapsed after responding to previous treatment with HMAs (115 of 299 patients enrolled), did not show a statistically significant survival benefit. Additional analysis is underway to identify potential survival benefit in other subsets of patients.
Preliminary safety analysis indicates that rigosertib was generally well tolerated in the study population. Severe adverse events were uncommon, with a similar profile of serious adverse events in both study arms. Grade 3/4 treatment-related hematologic and non-hematologic adverse events were reported in less than 7% and 3% of patients, respectively. Incidence of all grades of treatment-related nausea, diarrhea, fatigue and constipation were 22%, 17%, 17%, and 15%, respectively. All other treatment-related adverse events were reported in less than 10% of patients. Additional details, including secondary endpoints, will be presented at the 2014 ASCO Annual Meeting.
"While we are disappointed that the ONTIME trial did not meet its primary endpoint, we are encouraged by the significant treatment benefit seen in the subset of patients who had progressed on or failed HMAs i.e., patients who had not responded to prior HMA treatment. We look forward to presenting additional information after data analysis is completed," said Ramesh Kumar, Ph.D., President and Chief Executive Officer of Onconova. "We are working closely with our partners, Baxter and SymBio, as we evaluate the results of this study. We plan to engage with the U.S. Food and Drug Administration (FDA) and European regulatory agencies with the goal of determining the next steps in advancing development of rigosertib for this underserved patient population. We remain committed to advancing rigosertib to address important medical needs in MDS and solid tumors. Ongoing efforts include trials of oral rigosertib in transfusion-dependent lower risk MDS patients, where, after consultation with regulatory agencies, we are planning to initiate a Phase 3 trial as soon as possible," continued Dr. Kumar.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio products and solutions, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the marketing of the HyperSound® Audio System as a hearing improvement device. The HyperSound technology has been shown to improve the clarity of audio and speech comprehension in individuals with certain hearing impairments.
HyperSound is an innovation in audio that uses a thin film to generate an ultrasonic beam of sound. Like a flashlight controls a ray of light, HyperSound directs sound in a narrow beam limiting it to a specific location, creating a precise audio zone. When an individual enters the beam's radius, they hear immersive 3D audio, similar to wearing a surround sound headset. The characteristics of the HyperSound audio beam have been shown to enable individuals with certain hearing impairments to hear audio with more clarity. The Company believes that the combination of exceptional control over the placement of audio, and the immersive quality of the sound, makes HyperSound a disruptive innovation that has the potential to change not only the hearing-loss market, but commercial and consumer markets as well.
"We are extremely pleased to have passed the important milestone of FDA clearance," said Juergen Stark, CEO of Parametric Sound Corporation. "We are hard at work on the next generation of HyperSound products and we are confident they will improve the quality of life for millions of people who suffer from hearing impairments."
Researchers estimate that one in five Americans, and one in three people over age 65, suffer from hearing loss. Impacting over 48 million Americans, hearing loss is the third most common physical condition in the United States after arthritis and heart disease. An estimated 360 million people worldwide suffer from some form of hearing loss.
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, Metadoxine Extended Release (MDX; MG01CI), to treat cognitive dysfunction, announced today that it has appointed Dr. Tomer Berkovitz as Chief Financial Officer, effective May 1, 2014.
Analogic Corporation (Nasdaq:ALOG) announced today that it will conduct a conference call on Thursday, March 6, 2014, at 5:00 p.m. (ET) to discuss results for the second quarter ended January 31, 2014.
BioCorRx Inc. (OTCQB: BICX) is pleased to announce that Financial Industry Regulatory Authority ("FINRA") has approved the Company's application for a name change from Fresh Start Private Management Inc. to BioCorRx Inc. and assigned a new trading symbol, BICX under a new CUSIP number 09073C106. The market effective date for these changes is February 20, 2014. Until then, the ticker remains (OTCQB: CEYY).
Cempra, Inc. (Nasdaq:CEMP) today announced that Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra, will present at the RBC Capital Markets 2014 Global Healthcare Conference at 1:35 p.m. EST, Tuesday, Feb. 25, at The New York Palace Hotel in New York City, and at the Cowen 34th Annual Health Care Conference at 1:30 p.m. EST, Monday, March 3, at The Boston Marriott Copley Place in Boston.
Cesca Therapeutics Inc. (f/n/a ThermoGenesis Corp.), (Nasdaq:KOOL) today announced that it consummated the merger with TotipotentRX Corporation ("TotipotentRX") for approximately 12,490,800 shares of the Company's common stock, as contemplated by the previously announced Agreement and Plan of Reorganization (the "Merger Agreement").
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, reported today that total revenues for the fourth quarter and twelve months ended December 31, 2013 increased to $1.75 million and $6.37 million, respectively, up 18 percent and 19 percent from the comparable periods in 2012, respectively.
Curis, Inc. (Nasdaq:CRIS), an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers, today announced that the Company will present at the RBC Capital Markets Global Healthcare Conference at 1:35 p.m. ET on February 26, 2014, in New York City.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today announced that it recently debuted the first ever 3D printed hybrid exoskeleton robotic suit, in collaboration with 3D Systems (NYSE:DDD), at a Singularity University event in Budapest. Designers from 3D Systems created personalized three-dimensional elements from multiple 3D scans taken of Ekso Ambassador, Amanda Boxtel.
MannKind Corporation (Nasdaq:MNKD) focused on discovering, developing and commercializing treatments for diabetes, announced today that it will present at upcoming conferences.
The Medicines Company (NASDAQ: MDCO) is scheduled to present at the 2014 RBC Capital Markets' Global Healthcare Conference in New York on Tuesday, February 25th at 9:00 AM Eastern Time.
Medical Marijuana, Inc. (OTC Pink:MJNA) and HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. – are pleased to announce that the American Academy of Anti-Aging Medicine (A4M) has approved and is actively promoting HempMedsPX™ as a new Platinum Elite Sponsor on both the A4M and Worldhealth.net websites.
Novavax, Inc. (Nasdaq:NVAX) announced today that it will host a conference call and webcast to report its fourth quarter and year-end 2013 financial results on Monday, March 10, 2014, at 4:30 p.m. ET.
Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 31 countries, today announced a regulatory approval in Mexico for the company's new Microcyn60® Oral Care family of products intended for use as an adjunct treatment in both mouth and throat infections.
Onconova Therapeutics, Inc. (Nasdaq:ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that the Phase 3 ONTIME trial of intravenous (IV) rigosertib in patients with higher risk myelodysplastic syndromes (MDS) who had progressed on, failed or relapsed after prior therapy with hypomethylating agents (HMAs) did not meet the primary endpoint of overall survival compared to best supportive care (BSC).
Revance Therapeutics, Inc. (Nasdaq:RVNC), today announced that its management is scheduled to participate in the Cowen 34th Annual Health Care Conference in Boston.
ScripsAmerica Inc. (OTCBB:SCRC), today announced that the Company has commenced the prepayment of its outstanding convertible debt by issuing the first payment on its convertible note with the largest principal and closest conversion date.
Stereotaxis, Inc. (Nasdaq:STXS) today announced that it will release financial results for its 2013 fourth quarter and full year ended December 31, 2013 on Tuesday, February 25, 2014 after the close of the U.S. financial markets.
Steiner Leisure Limited (Nasdaq:STNR) today announced financial results for the fourth quarter and year ended December 31, 2013.
Tauriga Sciences, Inc. (OTCQB:TAUG), a diversified life sciences company focused on generating profitable revenues through license agreements and the development of a proprietary technology platform in the nano-robotics space, today announced the execution of a Memorandum of Understanding with the manufacturer of California's leading topical medicinal cannabis products ("Cannabis Manufacturer") since 2009.
Trinity Biotech plc (Nasdaq:TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, will report financial results for the fourth quarter fiscal year 2013 on Tuesday, March 4, 2014.
Dr. James Isobe of the Baptist Vein Center in Birmingham, Alabama today reported positive clinical outcomes and significant cost savings associated with the use of Vascular Solutions, Inc.'s (Nasdaq:VASC) reprocessing service for the ClosureFAST radiofrequency ablation catheters in the treatment of superficial venous incompetence.
SmallCapVoice.com, Inc. (SCV) announced today that a new audio interview with HempMedsPX(TM)—a corporate portfolio company of Medical Marijuana, Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp (OTCBB:CANV) and Medical Marijuana Inc (OTC Pink:MJNA), is now available.
VIVUS, Inc. (Nasdaq:VVUS) today announced that it will report financial results for the fourth quarter and year ended December 31, 2013 after the NASDAQ Market closes on Monday, February 24, 2014.