|Hemispherx Shares Jump 13+% ; Aeterna Zentaris' Article on Phase 2 Results for Zoptarelin Doxorubicin Published|
|By Staff and Wire Reports|
|Tuesday, 04 February 2014 20:34|
Hemispherx Biopharma, Inc. (NYSE: HEB), presented a summary of the results of its Phase I/II study from the poster presentation entitled "Seasonal Influenza Vaccine and a TLR-3 Agonist, Rintatolimod (Ampligen®), Given Intranasally Produced Cross-Reactive IgA Antibodies Against Pathogenic H5N1 Influenza HA" given at the American Society for Microbiology (ASM) Biodefense Conference in Washington, DC on January 30, 2014.
When FluMist®, a seasonal influenza vaccine, was administered intranasally in conjunction with Ampligen® (an experimental therapeutic), 92% of the subjects elaborated specific IgA antibodies against at least one of the homologous seasonal vaccine strains. Healthy volunteers also showed, surprisingly, enhanced IgA levels against emerging avian influenza viruses with the potential for causing a pandemic in humans. These antibodies were against one or more of 3 different strains of H5N1, H7N9, and H7N3. Two-thirds of these recipients showed a ≥4-fold increase in specific IgA levels over baseline and some had measurable IgA levels one year after receiving FluMist® in conjunction with Ampligen®.
A published challenge study in adults (aged 18-45) indicates that FluMist® alone generates ≥4 fold increase in serum HAI antibody response (a level thought to be protective) in 24% of recipients despite the fact that 85% of recipients were estimated to have been protected (Treanor, et al. (2000) Vaccine, 18:899). In Europe FluMist® is approved for individuals aged 2-17 compared to ages 2-49 in the US.
Dr. William Carter, CEO at Hemispherx, indicated that compared to systemic doses of Ampligen® used in other clinical studies, the amount of intranasal Ampligen® used in this study was as low as one eight thousandth (1/8,000) of the dose. In response to a question about safety, Dr. David Strayer, Medical Director at Hemispherx, indicated that there were no serious adverse events reported during the study and over 80% of the adverse events reported were mild.
The breath of immune response suggests that other groups, particularly vulnerable to influenza and unprotected by FluMist® alone, might benefit from an appropriate addition of an adjuvant.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ), announced that an article on Phase 2 results for zoptarelin doxorubicin (AEZS-108) in endometrial cancer has been published in the February issue of the International Journal of Gynecological Cancer. Zoptarelin doxorubicin, is the Company's cytotoxic peptide conjugate which specifically targets luteinizing hormone-releasing hormone ("LHRH") receptors. The article, "Efficacy and Safety of AEZS-108 (LHRH Agonist Linked to Doxorubicin) in Women With Advanced or Recurrent Endometrial Cancer Expressing LHRH Receptors: A Multicenter Phase 2 Trial (AGO-GYN5)", Emons G., Gorchev G., Harter P., Wimberger P., Stähle A., Hanker L., Hilpert F., Beckmann M.W., Dall P., Gründker C., Sindermann H., Sehouli J., outlines results of this study which had been previously presented at the European Society of Gynaecological Oncology's ("ESGO") annual meeting in September 2011. The article is currently available at this link.
"These encouraging results were the basis for our current Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with advanced, recurrent or metastatic endometrial cancer who have progressed and have received one chemotherapeutic regimen with platinum and taxane", stated David Dodd, President and CEO of Aeterna Zentaris. "This compound's innovative targeted approach potentially offers a much needed novel treatment option for women with endometrial cancer and could provide the Company with a significant market opportunity."
Phase 2 Study Results and Conclusion -- Forty-four patients were entered onto the study at 8 centers in Germany and 3 centers in Bulgaria. Forty-three of these patients were eligible. Two patients had a complete remission (5%) and 8 achieved a partial remission (18%). Stable disease for at least 6 weeks was observed in 44%. The median time to progression (TTP) was 7 months and median overall survival (OS) was 15 months. The most frequently reported grade 3 or 4 adverse effects were neutropenia (12%) and leucopenia (9%).
Data showed that zoptarelin doxorubicin has clinically meaningful activity with low toxicity in women with advanced or recurrent LHRH receptor positive endometrial cancer, supporting the principle of receptor mediated targeted chemotherapy.
Current ZoptEC Phase 3 trial in endometrial cancer -- This is an open-label, randomized, multicenter Phase 3 trial currently being conducted under a Special Protocol Assessment, comparing zoptarelin doxorubicin with doxorubicin as second line therapy for advanced, recurrent or metastatic endometrial cancer. The first patient was dosed in July 2013 and recruitment is ongoing at multiple sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in median Overall Survival. Lead investigators are David Scott Miller, MD, from the University of Texas Southwestern Medical Center, in Dallas, Texas, and Hani Gabra, MD, from the Imperial College London Hammersmith Campus in London, England.
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that industry veteran, Aaron Berg, has been promoted to Senior Vice President, Marketing and Sales.
Cerner Corporation (Nasdaq:CERN) today announced results for the 2013 fourth quarter and full year that ended December 28, 2013, delivering strong levels of bookings and revenue performance.
Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that the Company is scheduled to present at the 2014 BIO CEO & Investor Conference, February 10-11, in New York, NY.
Codexis, Inc. (Nasdaq:CDXS), a leading developer of biocatalysts for the pharmaceutical and complex chemistry industries, today announced that John Nicols, President and CEO of Codexis, will present a company overview at the 16th Annual BIO CEO & Investor Conference on Tuesday, February 11, 2014 at 1:00 p.m. ET in New York City.
Covance Inc. (NYSE: CVD) today reported results for its fourth quarter and year ended December 31, 2013. Net revenue in the fourth quarter was $623.1 million, representing 10.8% growth from the fourth quarter of 2012's GAAP result of $562.2 million, and 11.1% growth from the fourth quarter of 2012's pro forma result of $560.7 million.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today announced that it will release financial results for the fourth quarter and fiscal year ended December 31, 2013 on Thursday, February 13, 2014, before the market opens.
Eternity Healthcare Inc. (OTCBB:ETAH), a leading medical device and diagnostic company with special focus on diabetes management, announced today that they are in development of a noninvasive sugar monitoring device using saliva instead of blood.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark J. Ahn, Ph.D., President and Chief Executive Officer will present a corporate update at the 16th Annual BIO CEO & Investor Conference.
Healthcare Services Group, Inc. (Nasdaq:HCSG) reported that revenues for the three months ended December 31, 2013 increased approximately 10% to $303,833,000 compared to $277,039,000 for the same 2012 period.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB), presented a summary of the results of its Phase I/II study from the poster presentation entitled "Seasonal Influenza Vaccine and a TLR-3 Agonist, Rintatolimod (Ampligen®), Given Intranasally Produced Cross-Reactive IgA Antibodies Against Pathogenic H5N1 Influenza HA" given at the American Society for Microbiology (ASM) Biodefense Conference in Washington, DC on January 30, 2014.
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that the Company is the #4 innovator in the biotechnology industry, according to the scorecard published by the Wall Street Journal Online on WSJ.com, for the 13-week period ending January 31, 2014.
IntelGenx Corp. (TSXV:IGX) (OTCQX:IGXT), a Canadian drug delivery company focusing on oral drug delivery, and RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage drugs, today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for their VersaFilm™ Oral Film Product for the treatment of acute migraines.
Lipocine Inc. (OTCQB:LPCN), a specialty pharmaceutical company, today announced Mahesh Patel, President and CEO, and Morgan Brown, Executive Vice President and CFO, will present a company overview at the 2014 Leerink Global Healthcare Conference on Wednesday February 12, 2014 at 10:15 a.m. EST.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced today that the Company will release its financial results for the fourth quarter and year ended December 31, 2013, after the close of the stock market on Monday, February 24th, 2014.
Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that it has entered into a definitive agreement to acquire Crescendo Bioscience, Inc., a global leader in autoimmune diagnostics, for $270 million in cash which will be reduced by $25 million for the repayment of a loan made to Crescendo and customary adjustments in accordance with the acquisition agreement.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, today announced the expansion of intellectual property protection surrounding the Company's T-regulatory cell ("Treg") program with the grant of Japanese Patent Number 5409827 titled "Methods for the Isolation and Expansion of Cord Blood Derived T Regulatory Cells."
Pacific Biosciences of California, Inc. (Nasdaq:PACB) today announced financial results for the fourth quarter ended December 31, 2013.
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for 2013 and provided guidance for 2014. Net profit in 2013 was $31.5 million, or $0.70 per diluted share, compared to a net loss in 2012 of $3.4 million, or $0.08 per share.
PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced it has added Thomas DiNanno to its Advisory Board.
Premier, Inc. (Nasdaq:PINC) has introduced an enterprise-wide analytics solution enabling hospitals and health systems to easily access, integrate and interpret their data, any way they want to.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage drugs, together with IntelGenx Corp. (TSXV:IGX) (OTCQX:IGXT), a Canadian drug delivery company focusing on oral drug delivery, today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for RHB-103 for the treatment of acute migraines.
Relypsa, Inc. (Nasdaq:RLYP), a clinical-stage biopharmaceutical company, today announced that patient enrollment for its Phase 1 onset-of-action trial of patiromer for the treatment of hyperkalemia has been completed.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced that the company will release its fourth quarter and full year 2013 financial results on Tuesday, February 11, 2014, after the market closes.
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the 16th Annual Biotechnology Industry Organization (BIO) CEO & Investor Conference on Tuesday, February 11, 2014 at 11:30 AM ET.
Tornier N.V. (Nasdaq:TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that it will report financial results for the fourth quarter and full year ended December 29, 2013 after the close of the regular trading market on Thursday, February 20, 2014.
Urologix®, Inc. (OTCQB:ULGX), the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today reported financial results for its fiscal second quarter ended December 31, 2013.
Urologix®, Inc. (OTCQB:ULGX), the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today announced that it has secured an extension to June 30, 2014 of its credit facility with Silicon Valley Bank ("SVB"), the commercial banking division of SVB Financial Group.
Vascular Solutions, Inc. (Nasdaq:VASC) today reported financial results for the fourth quarter ended December 31, 2013, and provided financial guidance for the first quarter and full year of 2014.