|Gilead Provides Update on Investigational Compound, GS-5734; PositiveID Enters Into Agreement to Acquire Thermomedics|
|By Josh Gee|
|Wednesday, 21 October 2015 18:51|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 21, 2015.
Gilead Sciences, Inc. (NASDAQ:GILD) confirmed the company fulfilled a request for compassionate access to GS-5734, a novel nucleotide analogue in development for the potential treatment of Ebola Virus Disease (EVD). The request was received last week and drug was shipped later the same day. The compound is currently being provided to a female patient in the United Kingdom, as described earlier today by officials from the Royal Free Hospital in London.
“It is very encouraging to hear that the patient in question is doing better and is no longer in critical condition. Our thoughts and wishes for continued recovery are with her, with her family and the excellent medical team at Royal Free Hospital,” commented Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We recognize the urgent need for treatments to address Ebola and we are working with collaborators to advance development of GS-5734 as quickly as possible.”
GS-5734 was discovered as part of Gilead’s program to screen compounds in its libraries for activity against a range of potential emerging viruses, including Ebola. In collaboration with the Centers for Disease Control and Prevention (CDC) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the company identified GS-5734 in vitro activity against the Ebola virus.
In animal studies conducted at USAMRIID, treatment initiated on day 3 post-infection with Ebola virus resulted in 100 percent survival of monkeys. Data from these studies were recently presented at the annual Interscience Conference of Antimicrobial Agents and Chemotherapy / International Congress of Chemotherapy and Infection (ICAAC/ICC) meeting and at ID Week. Gilead recently initiated a Phase 1 clinical trial in healthy human volunteers to determine the safety, tolerability and pharmacokinetics of GS-5734.
Ebola represents a global public health crisis, and Gilead is working with USAMRIID and a number of private and public health entities to determine next steps on how to advance evaluation of GS-5734. In the event that the compound proves to be safe and effective in humans, Gilead plans to work to enable access as broadly and quickly as possible. In the interim, the company will review any requests for compassionate access on a case by case basis.
GS-5734 is an investigational compound that has not been proven safe and effective for EVD; additionally, its clinical effect in this particular patient case cannot be determined.
PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, announced today that it has entered into an agreement to acquire the capital stock of Thermomedics, Inc. (“Thermomedics”), which manufactures and markets the FDA-cleared Caregiver® non-contact clinical-grade thermometer. This acquisition is a part of PositiveID’s overall growth strategy to add revenue-generating, complementary products with significant market penetration potential to its portfolio. PositiveID will continue to look at other opportunities to execute this growth strategy.
The Caregiver thermometer was developed by the inventors of tympanic thermometry and is the world’s first non-contact device with TouchFree™ technology. Caregiver is a clinical-grade, infrared thermometer for measurement of forehead temperature in adults, children, and infants, without contact. Since there is no skin contact and Caregiver does not require probe cover supplies, it reduces the risk of cross-contamination and saves the healthcare facility the cost of covers (as much as $0.05 to $0.15 per temperature), storage space, as well as waste disposal costs.
Due to its ability to provide TouchFree temperatures thereby helping to improve infection control efforts, Caregiver has been utilized recently by both government and commercial customers in the fight against the spread of Ebola.
The established distribution and customer channels for Caregiver are expected to provide synergies to PositiveID as it continues the development and testing of its Firefly Dx real-time pathogen detection system and prepares for commercialization. Thermomedics currently has agreements with the world’s leading healthcare product distributors.
“We believe that once completed, the acquisition of Thermomedics will bring an exciting product and management team to our portfolio as we continue toward commercialization of Firefly Dx,” stated William J. Caragol, Chairman and CEO of PositiveID. “Not only will Caregiver provide additional revenue for PositiveID, we believe it will also provide opportunities to fight against the spread of disease, while providing a pathway to customers and delivering proven manufacturing and FDA expertise.”
The global market for temperature monitoring devices is forecast to reach $1 billion by 2020, with infrared thermometers experiencing the fastest growth driven in part by concerns over the spread of highly infectious diseases like Ebola according to Global Industry Analysts, Inc.
Further details of the transaction are described in a Form 8-K filed with the SEC by PositiveID. PositiveID expects to close the acquisition during the fourth quarter of 2015.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced data demonstrating that AR-12 has potent in vitro antiviral activity against HIV-1, HIV-2 and drug-resistant HIV-1. Results were presented today in a poster presentation during the 15th European AIDS Conference, which is hosted by the European AIDS Clinical Society (EACS) and being held October 21-24 in Barcelona, Spain. Results of the in vitro studies demonstrated that AR-12 inhibits HIV-1, HIV-2 and six drug resistant HIV-1 strains with 50% inhibitory concentrations (IC50) in the range of 240-1016 nM (nanomolar) and moderate cytotoxicity (5532 nM). The IC50s were found in this study to be consistent with the IC50s observed against other viral pathogens including Influenza A, Chikungunya, Ebola, Lassa and others. Previous studies have demonstrated AR-12 down regulates the host cell chaperone machinery, including GRP78, HSP70, HSP90 and HSP27. GRP78 is a critical chaperone protein, whose inhibition results in the up-regulation of PERK, inducing autophagy and facilitating the clearing of intracellular viruses and/or phagocytized unfolded proteins. Interfering with the host chaperone proteins in cells infected with viruses is thought to prevent the proper folding of viral proteins and efficient viral assembly. These findings suggest that AR-12 inhibits HIV through a mechanism of action different from other inhibitors currently on the market, encompassing the major classes of HIV drugs currently available. These preclinical investigations confirmed that host cell targeting by AR-12 may be an effective approach to inhibit the replication of HIV at low concentrations that can be achieved in the clinical setting with an oral tablet formulation.
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company with a focus on developing meaningful therapies for patients with unmet medical needs in diseases that have seen limited therapeutic innovation, and QIMR Berghofer Medical Research Institute, based in Brisbane, Australia (QIMR Berghofer), today announced that they have entered into exclusive license and research agreements. Under the terms of the agreements, Atara Bio obtained an exclusive, worldwide license to develop and commercialize allogeneic, or “off-the-shelf”, cytotoxic T-lymphocytes (CTLs) directed against multiple epitopes of the Epstein-Barr virus (EBVpoly) and multiple epitopes of the cytomegalovirus (CMVpoly) utilizing technology developed by QIMR Berghofer. The QIMR Berghofer technology complements Atara Bio’s ongoing CTL development efforts by selectively targeting certain epitopes and antigens. Initial applications for which the technology may be appropriate include the treatment of certain cancers such as gastric cancer, nasopharyngeal carcinoma (NPC) and glioblastoma multiforme (GBM) and certain autoimmune disorders such as multiple sclerosis (MS). “We are encouraged by the clinical safety and initial efficacy generated by QIMR Berghofer’s autologous CTL therapy programs. We are excited to partner with QIMR Berghofer to develop the technology into off-the-shelf therapies,” said Christopher Haqq, Chief Medical Officer for Atara Bio. “Our partnership with QIMR Berghofer enables Atara to potentially target broader indications with the EBVpoly-CTL and CMVpoly-CTL programs.” “This collaboration brings together the expertise and resources needed to pursue the research and development of off-the-shelf CTL products in multiple cancers and autoimmune disorders,” said Professor Rajiv Khanna, lead researcher on these projects and Coordinator of QIMR Berghofer’s Centre for Immunotherapy and Vaccine Development. “I am very excited about the opportunity to work with the Atara team to bring these new developments to patients.” QIMR Berghofer Director and CEO Professor Frank Gannon said, “The exclusive license and research agreements with Atara Bio provide an exciting opportunity for global expansion of QIMR Berghofer’s CTL therapy program.”
The Joint Corp. (NASDAQ:JYNT), management company for Harkins Chiropractic of So. California*, announced today that Addison Ashton-Boyd, D.C. is now onboard as Senior Director of Chiropractic Operations. In this new position Dr. Ashton-Boyd will be responsible for management, quality assurance and ongoing training at The Joint's Orange County-area clinics. Dr. Ashton-Boyd will focus on ensuring the delivery of consistently high levels of quality chiropractic patient care, while also developing professional relationships with local healthcare providers and patients. Dr. Ashton-Boyd earned his Doctorate in Chiropractic from Southern California University of Health Sciences, where he graduated with honors in 2011. He received his undergraduate degree in Human Biology from University of California, Irvine. Before switching to chiropractic, Dr. Ashton-Boyd was enrolled in the UC Irvine School of Medicine. His decision to focus on chiropractic demonstrates his strong commitment to the significant benefits to be gained from a preventive, natural, drug-free approach to pain management. Dr. Ashton-Boyd has lived in California for the past 16 years. Prior to working at The Joint, he served as director of SMMC's Physical Medicine and Rehabilitation Department. "Back pain and discomfort is usually just an indicator, a symptom, of a more involved set of issues developed over time based on how people live their daily lives," said Dr. Ashton-Boyd. "I firmly believe in the benefits of regular chiropractic adjustments as an effective tool that can deliver long-lasting benefits in each patient's individual quest for increased mobility and wellness."
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced the completion of its human abuse liability program of KP201, KemPharm's prodrug of hydrocodone, formulated in combination with acetaminophen (APAP), and reported top-line results from the KP201.A02 intranasal human abuse liability clinical trial. This trial was a phase 1 type clinical trial in 42 healthy, non-dependent recreational drug abusers, to determine the exposure, abuse potential, and safety of crushed intranasal (IN) KP201/APAP relative to crushed IN Norco® (hydrocodone bitartrate/APAP). KemPharm plans to present the full human abuse liability data package as part of its New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to the U.S. Food and Drug Administration (FDA) as early as by the end of 2015. In summary, data from the KP201.A02 intranasal human abuse liability trial confirmed that KP201/APAP may be able to limit hydrocodone exposure as compared to Norco® when both are administered intranasally. Liking scores were not significantly different, which KemPharm believes was potentially due to the effects of APAP. These results reaffirm the key properties of KP201/APAP that were observed in the prior oral human abuse liability trial (KP201.A01) and intranasal human abuse liability trial (KP201.A03).
Lombard Medical, Inc. (Nasdaq:EVAR), a medical device company focused on Endovascular Aortic Repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced that it will release its 2015 third quarter and nine-month financial results after the market closes on Wednesday, November 4, 2015. In conjunction with the release, the Company will host a conference call with the investment community at 4:30 p.m. Eastern Time on Wednesday, November 4, 2015, to discuss the financial results and other business developments. Interested parties may access the live call via telephone by dialing 1-855-327-6837 (domestic), 0808-101-2791 (UK toll free) or 1-631-891-4304 (international). To listen to the live call via Lombard Medical's website, go to www.lombardmedical.com, in the Events and Presentations section. A webcast replay of the call will be available following the conclusion of the call in the Events and Presentations section of the website.
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that new data on its myRisk™ Hereditary Cancer molecular diagnostic test will be featured in five presentations at the National Society of Genetic Counselors (NSGC) Annual Conference being held Oct. 21 to 24, 2015 in Pittsburgh, Pa. "Myriad is a pioneer in translating genetic information into products that save and improve lives. More than ever, we're dedicated to research that advances the science of hereditary cancer testing for patients now and in the future," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "The data we're presenting at NSGC this year demonstrate that the myRisk Hereditary Cancer Panel identifies more harmful mutations than testing one gene at a time. Furthermore, as we expand our testing to broader gene panels and identify mutations in genes that have not traditionally been linked to certain family histories, we are challenging the fundamentals of our historical thinking on cancer genetics."
Natus Medical Incorporated (NASDAQ:BABY) today announced financial results for the three months ended September 30, 2015. For the third quarter ended September 30, 2015, the Company reported revenue of $94.6 million, an increase of 5.2% compared to $89.9 million reported for the third quarter 2014. On a constant currency basis, revenue would have increased 6.7% to $95.9 million. GAAP net income was $10.9 million, or $0.33 per diluted share, compared with GAAP net income of $7.8 million, or $0.24 per diluted share in the third quarter 2014. The Company reported non-GAAP net income of $12.9 million for the third quarter ended September 30, 2015, an increase of 21.7% over the prior year of $10.6 million. Non-GAAP earnings per diluted share increased 18.1% to $0.39 for the third quarter 2015, compared to $0.33 in the third quarter 2014. For the nine months ended September 30, 2015, the Company reported revenue of $275.9 million, an increase of 5.4% compared to $261.8 million reported for the same period in 2014. On a constant currency basis, year-to-date revenue would have increased 7.1% to $280.5 million. GAAP net income was $29.4 million, or $0.89 per diluted share, compared with net income of $22.0 million, or $0.68 per diluted share in the third quarter of 2014. The Company reported non-GAAP net income of $34.4 million for the nine months ended September 30, 2015, an increase of 23.7% over the prior year of $27.8 million. Non-GAAP earnings per diluted share increased 20.9% to $1.04 for the third quarter 2015 from $0.86 per diluted share reported for the same period in the previous year.
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced that it has initiated a phase 1b/2 clinical trial (Study OX1222) of its investigational drug OXi4503 for treatment of acute myeloid leukemia (AML). OXi4503, which has shown significant activity in preclinical studies of AML, is a novel VDA that is designed to reduce blood flow to tumors and to prevent cancer cells from replicating. Study OX1222 is a continuation and expansion of a phase 1 single site clinical trial of OXi4503 conducted by the University of Florida (UF) with support from the Leukemia & Lymphoma Society. OXiGENE is expanding upon the UF study to speed collection of additional safety and efficacy data and to obtain clinical data for OXi4503 in combination with cytarabine, which is an approved treatment for AML. "OXi4503 is a promising new investigational drug for patients with Myelodysplastic Syndromes and Acute Myeloid Leukemia," stated Christopher R. Cogle, M.D., Associate Professor of Medicine, University of Florida, and the principal investigator of the study. "Blood vessels are hiding spots for these diseases. OXi4503 is a first-in-class drug that rouses sleeping leukemia cells from vascular beds and primes leukemia cells to cytarabine chemotherapy."
Strongbridge Biopharma plc (NASDAQ:SBBP) announced today the closing of its initial U.S. public offering of 2,500,000 ordinary shares at a price to the public of $10.00 per ordinary share for aggregate gross proceeds of $25 million, before deducting the underwriting commission and estimated offering expenses. In connection with the offering, Strongbridge Biopharma has granted to the underwriters a 30-day option to purchase up to an additional 375,000 ordinary shares at the public offering price, less the underwriting discount. Strongbridge Biopharma's ordinary shares are listed on The NASDAQ Global Select Market under the symbol "SBBP". Stifel acted as the sole book-running manager for the offering. JMP Securities acted as lead manager, and Roth Capital Partners and Arctic Securities acted as co-managers. A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on October 15, 2015. The offering is being made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from: Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attention: Syndicate, by telephone at (415) 364-2720 or by email at [email protected]
VBL Therapeutics (NASDAQ:VBLT), today announced positive results from its multi-cohort Phase 2 trial of VB-111 in advanced radioiodine-refractory differentiated thyroid cancer (RAIR-DTC). The pre-specified primary trial endpoint of 6-month Progression Free Survival (PFS) for at least 25% of enrolled patients was met, showing a dose response for VB-111. In the trial, which was conducted at the Mayo Clinic and Massachusetts General Hospital, VB-111 also demonstrated favorable safety and survival data, and a potential for dose-dependent disease stabilization. The results were presented today at the 15th International Thyroid Congress held in Orlando, FL. The trial, which was designed to assess the safety and efficacy of VB-111, enrolled 29 patients with metastatic radioiodine resistant differentiated thyroid Cancer (RAIR-DTC), whose disease had progressed within the 6 months prior to enrollment. Most of the patients' cancers had previously not responded to various therapeutic interventions including radiation, tyrosine kinase inhibitors and cytotoxic agents. The primary endpoint required at least 25% of enrolled patients to achieve 6 month PFS. The patients in this open-label, dose-escalating trial, were treated in two cohorts. In the first cohort, 12 patients received a single intravenous infusion of VB-111 at a low dose of 3X1012 viral particles (VPs). The second cohort included 17 patients who received VB-111 at a high dose of 1013 VPs every two months, until disease progression. Six patients (35%) in the high-dose cohort (n=17) met the primary endpoint of 6-month PFS using Response Evaluation Criteria in Solid Tumors (RECIST), compared to three patients (25%) in the low-dose cohort (n=12). PFS at 12 months was 25% in the VB-111 high-dose cohort, versus 0% in the low-dose cohort, potentially indicating dose-dependent disease stabilization. Several patients also had lesional objective responses, such as complete or partially resolved metastatic lesion or metastatic lymph node. To this point, patients in the trial have a median overall survival (OS) of 20 months: 18 months in the low-dose cohort and 22 months in the high-dose cohort. Nine patients remain alive – one in the low-dose cohort (8%) and eight in the high-dose cohort (47%), all of whom are beyond 18 months and still being followed. "This Phase 2 trial was initiated following our Phase 1 'all comers' trial for VB-111, in which we noticed that the two patients enrolled with late-stage thyroid cancer each responded to treatment with VB-111," said Dror Harats, MD, CEO of VBL Therapeutics. "Meeting the primary endpoint of 6-month PFS in the current Phase 2 trial, along with the favorable overall survival data to date, further support the potential efficacy of VB-111 in patients with RAIR-DTC."
WaferGen Bio-systems, Inc. (NASDAQ:WGBS) today announced that the Company has completed the previously announced underwritten public offering. Due to the exercise in full of the underwriters' over-allotment option, the Company received gross proceeds of $17.25 million and issued a total of 6,170,000 shares of common stock, shares of preferred stock convertible into 11,080,000 shares of common stock and warrants to purchase 17,250,000 shares of common stock. The preferred stock issued in this transaction includes a beneficial ownership blocker, but has no dividend rights (except to the extent dividends are also paid on the common stock), liquidation preference or other preferences over common stock. Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Financial Services Inc., acted as sole book-running manager for the offering, and Chardan Capital Markets, LLC, and Dougherty & Company acted as co-managers. The net proceeds of the offering are estimated to be approximately $15.7 million, after deducting underwriting discounts and commissions and estimated offering expenses. WaferGen intends to use the net proceeds from the offering for research and development initiatives, ICELL8™ Single-Cell System-related commercialization activities and for general corporate and working capital purposes.