|Research From the Mayo Clinic Utilizing the BVA-100 Blood Volume Analyzer; CEL-SCI Reports September Patient Enrollment for Its Phase 3; XOMA Announces Development and Commercialization Agreement|
|By Marilyn Mullen|
|Thursday, 01 October 2015 18:41|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 1, 2015.
Daxor Corporation (NYSE MKT: DXR), a medical instrumentation and biotechnology company, announced that Dr. Wayne Miller, a cardiologist from the Mayo Clinic, presented research at the annual meeting of the Heart Failure Society which documented and quantified blood volume derangements in congestive heart failure patients. The study demonstrated that the majority of congestive heart failure patients deemed anemic by the usual serum hemoglobin measurements in fact had pseudo-anemia, an appearance of anemia arising from excessive plasma volume. Of these low-hemoglobin patients, 32% had normal red blood cell volume, 47% had excess red blood cell volume, and only 21% had true anemia.
The first derangement which usually occurs in heart failure patients is the retention of salt and water, which causes an expansion of the patient's blood volume resulting in congestion in the lungs. Once cardiac patients reach the point of requiring hospitalization, their prognosis is grim: 30% to 40% are dead within a year of their first admission. Congestive heart failure is the #1 cause for hospitalization in patients over 65 and costs an estimated $35 to $37 billion in hospital costs annually. Approximately 25% of patients admitted for heart failure are so unstable that they are readmitted within 30 days. In 2013, Medicare instituted penalties for hospitals if patients were readmitted within 30 days or fewer. These financial penalties are designed to motivate hospitals to avoid the premature discharge of patients who are unstable. For hospitals, the problem is that they are paid a fixed fee for certain diagnoses, such as decompensated heart failure, whether the patient is in the hospital for 2 days or 6 days. Hospitals, therefore, have a great financial incentive to discharge patients as early as possible.
Physicians treating congestive heart failure are not currently able to form an accurate picture of the patient's blood volume status using routine clinical and laboratory evaluation. Yet the stakes are high for accurate assessment of this high-needs patient population. Overly aggressive treatment may precipitate kidney failure, while incomplete treatment may result in the patient becoming symptomatic within 30 days or less and being readmitted to the hospital. Anemia is an important consideration in determining the treatment approach.
The research by Dr. Miller is a clear signal that direct blood volume measurement with the Daxor BVA-100 Blood Volume Analyzer enables physicians to accurately quantify the blood volume derangement underlying congestive heart failure presentation and offers the potential to calibrate treatment more precisely than has been possible in the past.
Additionally, at a panel on the measurement of congestion in heart failure, Dr. Miller's work with blood volume analysis was cited as important and intriguing in view of the urgent need to better understand and address the heterogeneity and complexity of heart failure patients.
The HFSA meeting is attended by more than 1,800 physicians and specialized cardiac nurses, The Mayo Clinic is listed as the #1 hospital in the U.S. out of more than 4,000 institutions; its cardiology department, where Dr. Miller's research was performed, is listed as the #2 cardiology department in the U.S.
Daxor Corporation manufactures and markets the BVA-100 blood volume analyzer, which is used in conjunction with a single-use diagnostic kit. The instrument is the only FDA approved semi-automated instrument to provide this test. Preliminary results can be available in 30 minutes and complete results in under an hour. To learn more about Daxor, please visit www.Daxor.com.
CEL-SCI Corporation (NYSE MKT: CVM) announced in the month of September it has enrolled 30 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer. Total patient enrollment is now 570 as of September 30, 2015 in the world's largest Phase 3 study in head and neck cancer.
A total of 880 patients are expected to be enrolled in over 20 countries.
XOMA Corporation (NASDAQ: XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has exclusively licensed the global development and commercialization rights to its anti-transforming growth factor-beta (TGFb) antibody program to Novartis. Under the terms of the agreement, XOMA will receive $37.0 million in the form of an upfront payment and is eligible to receive up to $480.0 million if all development, regulatory, and commercial milestones are met. In addition, XOMA is eligible to receive royalties on product sales that range from the mid-single digits to the low double digits. In connection with this license agreement, Novartis has agreed to extend the maturity date on the approximately $13.5 million of outstanding debt under the secured note agreement, which bears interest at the six-month LIBOR plus 2% (currently 2.53%), to September 30, 2020. XOMA has also agreed to reduce the royalty rate to XOMA associated with Novartis' clinical stage anti-CD40 antibodies.
"XOMA and Novartis have worked closely together for several years to develop new product candidates. When they expressed interest in our anti-TGFb program, we knew Novartis was the best company to bring this exciting potential therapy to the patients whom it may help," stated John Varian, Chief Executive Officer of XOMA. "Novartis is recognized as a leader in oncology, where an anti-TGFb molecule has real potential either as monotherapy or in combination with other therapeutic options.
"We had said we did not plan to raise equity capital at our recent stock price in order to fund the development of our very exciting endocrine portfolio. With this non-dilutive liquidity of essentially $50.5 million, we currently project this capital, in combination with our planned cost savings measures, will fund operations into 2017. We remain on track to begin our XOMA 358 Phase 2 clinical program this fall and fully anticipate we will have the data from these studies during that timeframe," concluded Mr. Varian.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today that the first patient surgical implantation of the Alphatec Neocore™ Osteoconductive Matrix, a synthetic scaffold for the regeneration of bone, was successfully completed. The Company will be showcasing Alphatec Neocore, as well as its portfolio of products at the upcoming North American Spine Society (NASS) Annual Meeting being held at McCormick Place West, Chicago, Illinois, from October 14th - 16th, 2015. Alphatec Spine will be located in booth number 1147. “Alphatec Neocore provides surgeons with the handling characteristics and osteoconductive composition they’ve been looking for in bone grafting products,” explains Jim Corbett, President and Chief Executive Officer of Alphatec Spine. “Alphatec Neocore will expand our biologics opportunity —both here in the U.S. and internationally. This exciting new global biologic brand will give us the ability to operate more broadly in the global marketplace, bringing a compelling synthetic bone regeneration solution and competitive pricing to our surgeon and hospital customers worldwide.”
Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced the Company's intention to strategically focus the majority of its resources on the development of Engineered Skin Substitute (ESS) for the treatment of rare pediatric diseases, including the treatment of pediatric severe burns and Congenital Giant Hairy Nevus. Management believes the ESS program represents a vast commercialization opportunity and its near term advancement is critical to the Company's overall business strategy. Additionally, treatments in development for rare pediatric diseases in the United States are eligible to receive Rare Pediatric Disease Designation (RPDD). The Sponsor of a treatment that is approved by the US Food and Drug Administration (FDA) under the RPDD pathway is entitled to receive a Priority Review Voucher (PRV). "With the integration of the Cutanogen acquisition now complete, we have unearthed powerful human clinical data that validates the significant potential for the ESS program beyond the areas of adult and pediatric severe burns and into Congenital Giant Hairy Nevus," said Gerald E. Commissiong, President & CEO of Amarantus. "It is important for us to now focus the majority of our resources over the next several months on the ESS program. Upon completion of our review of the long-term longitudinal data, we intend to work closely with the FDA in an effort to establish a shortened clinical development pathway to approval via the RPDD pathway."
Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), today announced presentation of data at the 2015 American Association for the Study of Liver Diseases (AASLD) Liver Meeting being held on November 13 – 17, 2015, at the Moscone West Convention Center, San Francisco. "We are encouraged by the supportive data generated for TKM- HBV, our lead HBV clinical candidate, and are focused on advancing the development of this product as well as our other HBV candidates," said Dr. Mark J. Murray, Arbutus' President and CEO. "Our preclinical data support reduction of hepatitis B surface antigen (HBsAg) by TKM-HBV, as well as complementary effects when combined with currently approved nucleos(t)ide analogs."
Cellectar Biosciences, Inc. (NASDAQ:CLRB), a clinical stage biopharmaceutical company developing phospholipid drug conjugates (PDCs) for cancer targeted delivery of diverse oncologic payloads for the treatment of cancer, announced today it has received initial notice of award for a Phase I-II Fast-Track Small Business Innovation Research (SBIR) grant. This SBIR grant provides up to $2.3 million from the National Cancer Institute (NCI) to fund development of Cellectar's PDC platform for targeted delivery of I-125, a radiotherapeutic isotope that may be uniquely suited to treat micro-metastatic disease. "The receipt of this SBIR grant further validates our PDC delivery platform's potential to improve the therapeutic index and product performance of known cytotoxic agents through targeted delivery," commented Jim Caruso, CEO and President of Cellectar Biosciences. "This grant provides non-dilutive capital to expand our radiotherapeutic PDC pipeline beyond our lead candidate, CLR 131, with the development of CLR 125, a new PDC product candidate. We look forward to further characterizing the potential clinical utility CLR 125 may possess in the treatment of cancer." The SBIR grant is awarded in two installments with the potential for up to $2.3 million over two and a half years. The Phase I funding segment of $300,000, which will support all of the costs projected for preclinical work with CLR 125, is now being funded. The second phase of the grant provides $2.0 million of funding for a phase 1 clinical study of CLR 125 to determine safety, tolerability and optimal dosing.
Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today reported the results from its pharmacokinetic and pharmacodynamic (PK/PD) clinical study of CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This study met its primary PD endpoints of absolute neutrophil count (ANC). In terms of PK parameters, the study also met bioequivalence for Cmax. The Area Under the Curve (AUC) portion of the PK results are still under review. Given these overall positive results, Coherus remains on track for its planned BLA filing in the first quarter of 2016. This randomized, double-blind, single-dose, two-period crossover study in healthy subjects assessed PK, PD, and safety of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta. A total of 116 healthy volunteer subjects were randomized to one of two treatment sequences; Neulasta (Period 1) then CHS-1701 (Period 2) or CHS-1701 (Period 1) then Neulasta (Period 2).
Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) announced today that abstracts for two posters addressing preclinical results with the company's pan-caspase inhibitors, have been accepted for presentation at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco November 13-17, 2015. Accepted abstracts were published today on the AASLD website at www.aasld.org/ for posters entitled, "Alcohol stimulates macrophage activation through caspase dependent, hepatocyte derived release of CD40L containing extracellular vesicles," (poster #1315), and "Emricasan, a pan caspase inhibitor, improves survival and portal hypertension in a murine model of long-term common bile-duct ligation," (poster #1522). "There is a growing body of scientific data highlighting the role of biologically active microparticles in the progression of liver disease," said Al Spada, Executive Vice President of Research and Development and Chief Scientific Officer of Conatus, "particularly in cirrhosis and its related complications such as portal hypertension. The data being presented at the upcoming AASLD meeting provide mechanistic support for the recently announced top-line results from our Portal Hypertension trial and encourage continued development of emricasan."
Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced that John Maslowski, Senior Vice President of Scientific Affairs, will present on Thursday, October 8 at 4:45 p.m. PDT at the annual Partnering Forum, part of the Stem Cell Meeting on the Mesa to be held October 7-9 in La Jolla, California. This regenerative medicine conference brings together senior executives and top decision makers from the industry's scientific community with the goal of advancing and translating cutting-edge research into potential treatments and cures. Mr. Maslowski's presentation will be webcast live under the Investors & Media section of Fibrocell's website at fibrocell.com/investors/events-and-presentations, and also posted on the Alliance for Regenerative Medicine's (ARM) website shortly after the event. Please visit Fibrocell's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
Greatbatch, Inc. (NYSE:GB) announced today that it will host a conference call on Thursday, October 29, 2015 at 5:00 p.m. E. T. to discuss its financial results for the third quarter 2015 ended October 2, 2015. The earnings conference call can be accessed from the Greatbatch web site at www.greatbatch.com. A press release detailing the financial results will be issued after the market closes on October 29, 2015. The conference line is 866.562.8327 and the participant passcode is 52772884.
Histogenics Corporation (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that Company Management will be participating in four upcoming conferences. The presentations that are webcast live may be accessed by visiting the Investor Relations section of Histogenics' website at www.histogenics.com. The webcasts will be available on Histogenics' website for approximately 45 days following the respective conferences.
IEH Biopharma LLC, a subsidiary of Icahn Enterprises L.P. (NASDAQ:IEP) has affirmed its previously announced cash tender offer (the "Offer") for any and all of the outstanding 4.50% Convertible Senior Notes due 2020 of VIVUS, Inc. (the "Notes"). The offer price for any or all Notes tendered pursuant to the Offer will be $680 for each $1,000 of principal amount of Notes validly tendered and not validly withdrawn, plus accrued but unpaid interest from the last interest payment date up to, but excluding, the date of payment for the Notes by the Offeror. The Offer will expire at 5:00 p.m., New York City time, on October 7, 2015, unless the Offer is extended or earlier terminated (such time and date, as the same may be extended, the "Expiration Date"). Tendered Notes may be withdrawn at any time prior to the Expiration Date. Payment for the Notes will be made within three business days after the Notes have been accepted for payment. The Offeror is not obligated to purchase any Notes that are validly tendered in the Offer unless there has been validly tendered in the Offer and not withdrawn before the expiration of the Offer that number of Notes which represents a majority of the principal amount of the issued and outstanding Notes as of the Expiration Date. The consummation of the Offer is also conditioned upon other customary conditions described in the Offer to Purchase, dated September 9, 2015.
INC Research Holdings, Inc. (Nasdaq:INCR), a leading, global Phase I to IV contract research organization, today announced it is certified to use the iCardiac Early Precision QT approach for evaluating the cardiac safety of new compounds in Phase I clinical development. INC's use of iCardiac Early Precision QT may help customers reduce costs, and increase the accuracy, reliability and speed of cardiac safety testing in clinical research. "INC Research continually seeks innovations that enhance the full drug development lifecycle," said Jamie Macdonald, Chief Executive Officer. "Achieving certification to conduct trials using iCardiac Early Precision QT is a prime example of the Company's focus on driving efficiency for customers through new approaches. As drug development becomes increasingly complex and the amount of data captured, stored and applied multiplies exponentially, this approach has the potential for significant time and cost savings for customers." Since 2005, the FDA has required all new compounds under development to be tested to determine their impact on the QT interval – the time between the start of the Q wave and the end of the T wave during the heart's electrical cycle. A lengthened QT interval indicates potential safety risk factors for a new drug.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has acquired the following practices in Ocala, Florida: Ocala Hospital Group, PA; Hospitalists of Ocala, LLC; and Ocala Geriatric Services. The acquisitions complement IPC Healthcare's existing market presence for acute and post-acute services in the Ocala region. "We continue to focus on acquiring quality practices that further enhance IPC's presence in existing markets, and we are excited to welcome the talented clinicians of all three of these practices to the IPC team," said R. Jeffrey Taylor, president and COO of IPC Healthcare. "We already overlap with these groups in several facilities, and we believe that through consolidation of the groups IPC can ultimately provide a more consistent and aligned service to those facilities and to the community." The three acquisitions are expected to add more than 130,000 encounters on a combined annualized basis.
Lightlake Therapeutics Inc. (OTCQB:LLTP), a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive, and eating disorders, announced today that it has received a second funding commitment from a prominent international research and development foundation. The foundation has a focus on promoting innovative research-based initiatives, including those addressing health issues. Lightlake has been planning studies that could potentially advance multiple indications that address key health issues. The foundation's commitment is for up to $1,600,000, with the foundation receiving up to an approximately 2.1% interest in the net profits of Lightlake's products, other than its opioid overdose reversal treatment, that materially rely on these studies, as defined in the funding commitment investment agreement.
MTBC (Nasdaq:MTBC), a leading provider of proprietary, healthcare information technology solutions today announced that its ICD-10 mHealth app has emerged as the most popular ICD-10 app among U.S. healthcare providers. Today marks the Centers for Medicare and Medicaid Services' (CMS) mandatory conversion date from ICD-9, the legacy diagnosis code set used for medical billing, to the new generation of codes known as ICD-10. This conversion has significantly increased the complexity involved in selecting the codes required to support appropriate reimbursement and is upending the prevailing paper-based model for capturing billing information. MTBC's ICD-10 technology solutions enable physicians to quickly and easily transition to ICD-10. As one MTBC client, Amanda Richline, DPM, recently explained, "Before we started with the MTBC ICD-10 Solutions Team, we were very worried about ICD-10." She continued, "But with MTBC's ICD-10 solution, the conversion has been an amazingly painless and pleasant experience."
Pacific Biosciences of California, Inc., (NASDAQ:PACB) a pioneer and leader in long-read sequencing using Single Molecule, Real-Time (SMRT®) Technology, today announced that its technology will be featured in 36 presentations at next week's American Society of Human Genetics (ASHG) 2015 annual meeting taking place in Baltimore, Maryland. The company will also display its new instrument, the Sequel™ System, which was launched yesterday. The Sequel System provides higher throughput, more scalability, a reduced footprint and lower sequencing project costs compared to the PacBio® RS II System, while maintaining the existing benefits of the company's SMRT Technology. "We are excited to support the human genetics community as they pursue the generation of higher-quality whole human genomes, and move beyond SNPs to sequence the full size-spectrum of human genetic variation," said Jonas Korlach, Chief Scientific Officer of Pacific Biosciences. "With the introduction of our Sequel platform, SMRT Sequencing will be available to more scientists seeking to find the underlying heritability of genetic diseases."
Premier, Inc. (NASDAQ:PINC), a leading healthcare improvement company, has acquired InflowHealth LLC, a SaaS-based software developer that specializes in improving the operational and financial performance of physician practices. "Given today's public policy environment, providers have a real need for solutions that can help them better manage the complex world of physician practice economics," said Wes Champion, senior vice president of Premier Performance Partners. "InflowHealth's solution gives physicians unique insights into their financial, operational and strategic performance, allowing them to identify opportunities for improvement and guide practice budgeting and strategic investments. These are central capabilities for managing any successful practice, only growing in importance as physicians start to explore clinically integrated networks and alternative payment models, such as bundled payment and shared savings." InflowHealth's analytics solution aggregates financial and operational data from thousands of physicians in medical groups across the United States to perform precise calculations that pinpoint exactly where improvements can be made.
REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company in gene therapy, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to REGENXBIO's investigational gene therapy product candidate RGX-111 for the treatment of mucopolysaccharidosis Type I (MPS I). "REGENXBIO is pleased to have received Orphan Drug Designation from the FDA for RGX-111," said Kenneth T. Mills, President and CEO of REGENXBIO. "MPS I is a severely debilitating disease and patients and their caregivers do not currently have adequate therapeutic options. We remain committed to our vision of developing gene therapies for patients with high unmet medical needs, including MPS I." FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity. MPS I is a rare neurodegenerative disease caused by deficiency of the a-l-iduronidase (IDUA) gene. Over 1,000 individuals with MPS I are estimated to be born each year worldwide. Symptoms include excessive accumulation of fluid in the brain, spinal cord compression and cognitive impairment. RGX-111 uses an AAV9 vector to deliver the IDUA gene to the central nervous system.
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that its new website for Triferic has launched at www.triferic.com. The new website includes extensive product information to educate patients and healthcare providers about Triferic's unique mode of action and its advantages and clinical benefits over current iron therapy. Triferic is the only FDA approved iron product indicated to replace iron and maintain hemoglobin in hemodialysis patients in the United States.
SANUWAVE Health, Inc. (OTCQB:SNWV), a shockwave technology company, announced today that Kevin A. Richardson II, SANUWAVE's Chairman of the board and Chief Executive Officer, and Lisa Sundstrom, SANUWAVE's Interim Chief Financial Officer, will present at the 2015 Aegis Growth Conference, being held Wednesday, October 7, 2015 through Friday, October 9, 2015 at the Encore at Wynn Las Vegas, Las Vegas, Nevada. Event: 2015 Aegis Growth Conference, Date: Thursday, October 8, 2015, Time: 9:30 a.m. – 10:00 a.m. PT, Location: The Encore at Wynn Las Vegas, Las Vegas, Nevada. Company management will be available for one-on-one meetings with investors participating in the conference. For those investors who would like to schedule an appointment, please contact Todd Markey by phone, (818) 280-6800, or email [email protected]
SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it will host a meeting for analysts and institutional investors on Thursday, October 15, 2015, in Chicago from 7:30 a.m. to approximately 9:00 a.m. Central Time. The meeting will include presentations by members of SeaSpine's senior management team highlighting the Company's business strategy and plans for executing on related growth initiatives, as well as presentations by leading spine surgeons who will provide relevant customer perspectives. A live webcast of the event will be accessible from the Investor page of the SeaSpine corporate website at www.seaspine.com. A replay will be available on the Company's website following the event.
Signal Genetics, Inc. (NASDAQ:SGNL), a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced that Samuel D. Riccitelli, President and CEO, will present a corporate overview at the 2015 Aegis Growth Conference on October 8, 2015. Event: 2015 Aegis Growth Conference, Date: Thursday, October 8, 2015, Time: 10:45 a.m. PT. An audio webcast of the Company's presentation will be available on the investor relations section of the Signal Genetics website at www.signalgenetics.com. A replay of the presentation will be available for 90 days.
UCHealth's University of Colorado Hospital (UCH), a national leader in pulmonology, cancer and upper airway disorders, opens its new multidisciplinary program—the Center for Lungs and Breathing, designed to provide expert, integrated patient care. By bringing together nationally-renowned specialists in state-of-the-art facilities, the center will be able to provide an increased level of care and ensure the best possible outcomes for patients.
Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today released confirmatory data from its ongoing Extension Study of somavaratan in pre-pubertal GHD children at the 54th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE) in Barcelona, Spain. These data were previously disclosed in the poster abstract (see press release), and today is the first time the results are being shared as a poster presentation. George Bright, MD, Versartis Vice President of Clinical Development, will discuss the results at the Growth Hormone and IGF Treatment poster session (poster LBP-1267) from 1:30-2:30 PM Barcelona Time (CEST) on Saturday, October 3. Jay Shepard, Chief Executive Officer, commented, "Data presented at the ESPE conference provide further validation of the 3.5 mg/kg dose of somavaratan that we are currently using in our VELOCITY Phase 3 trial for pediatric growth hormone deficient patients. As we have demonstrated in previous trials and continue to show with these recent data, somavaratan is a long-acting treatment for GHD that may provide a safe and effective alternative to the daily injections that are the current standard of care. We continue to collect data from our ongoing global studies to support filing for approval in targeted markets and potential commercialization of somavaratan worldwide."
XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA). XBiotech's antibody therapy, known as 514G3, is currently being evaluated in a Phase 1/2 clinical study and was developed from a human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus. 514G3 knocks out the principle immune evasion mechanism of the bacteria, allowing white blood cells to detect and destroy the bacteria. 514G3 is expected to treat all strains of MRSA and can be used without consideration for strain-specific resistance to various antibiotics. As a True Human monoclonal antibody, 514G3 is expected to be well tolerated without the side effects or risks of antibiotics. John Simard, the Company's Chief Executive Officer, said, "Receiving FDA Fast Track Designation highlights the importance for this product candidate to treat life-threatening bacterial infections. We look forward to reporting on further developments as this important program continues to generate clinical findings."