|Egalet Announces Topline Results From Egalet-001; Geron to Assume Sponsorship of Myelofibrosis IST and IND|
|By Staff and Wire Reports|
|Wednesday, 06 August 2014 19:00|
Egalet Corporation (Nasdaq: EGLT) announced that we have top-line results from two of the three bioequivalence (BE) studies of Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.
Study 067-EG-005 evaluated the area under the curve (AUC) and the maximum or peak plasma concentration (Cmax) of Egalet-001 100 mg versus the same dose of MS Contin in a fasted state in 58 subjects. The results of this study demonstrated that Egalet-001 in comparison to MS Contin met the bioequivalence criteria on the measure of AUC but was outside the range (90 percent confidence interval of 80 to 125 percent) for Cmax.
Study 067-EG-004 examined the effect of food on the pharmacokinetic (PK) profile of Egalet-001 100 mg compared to MS Contin 100 mg in 52 subjects. Similar to study 067–EG-005, Egalet-001 met the criteria for bioequivalence to MS Contin on the measure of AUC but was outside the range for Cmax. In this study food did not increase the Cmax or the AUC of Egalet-001 when compared to other PK studies of Egalet-001 in subjects in a fasted state. In contrast, changes in the Cmax of MS Contin were demonstrated when compared to other PK studies of MS Contin in subjects in a fasted state, consistent with previously reported studies. This suggests that Egalet's Guardian™ Technology will not result in a clinically relevant food effect.
In both studies Egalet-001 was well tolerated and no serious adverse events were reported. In addition, study 067-EG-006, a 15 mg fasted BE study, is ongoing with results expected in the third quarter of 2014.
"There have now been four studies showing consistent AUC results when comparing Egalet-001 to the reference drug MS Contin including study 067-EG-002, a PK trial of Egalet-001 60 mg, in which bioequivalence was demonstrated for both AUC and Cmax compared to the same dose of MS Contin," said Jeff Dayno, MD, Egalet's chief medical officer. "We are evaluating the impact of the abuse-deterrent formulation of the 100 mg tablet on the findings from the 067-EG-005 study."
In March of 2014 the FDA issued draft guidance which states that the FDA, when evaluating approaches of bioavailability and bioequivalence for NDA submissions, will use the totality of information which includes the principles of BE, PK-PD correlation and clinical trial results.
"While we will leverage our fast track designation to determine if we can pursue the BE path in light of the March 2014 guidance and based on results from the ongoing 15 mg trial, and the successful 60mg PK study, we will plan for a potential efficacy study should it be required to move forward to a NDA submission for Egalet-001," said Bob Radie, president and chief executive officer. "Based on our PK results plus our robust Category 1 abuse-deterrent data and the ongoing Category 2/3 study, we are committed to advancing Egalet-001 to fill an unmet need in the marketplace where there are no abuse-deterrent morphine products currently available for individuals living with chronic pain."
Geron Corporation (Nasdaq: GERN) announced today that the company has entered into a transfer agreement with Mayo Clinic whereby the Investigational New Drug (IND) application for imetelstat under which the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST) has been conducted will be transferred from Mayo Clinic to Geron. In addition, Geron will assume sponsorship for the Myelofibrosis IST, and Dr. Ayalew Tefferi will remain the principal investigator for the study.
The company and Mayo Clinic have agreed that the IND and sponsorship responsibility for the conduct of the Myelofibrosis IST will be transferred to Geron by September 30, 2014. In light of the full clinical hold placed on the company's IND, Geron has committed to the U.S. Food and Drug Administration (FDA) that the company will not initiate any new clinical studies under the transferred IND from Mayo Clinic until Geron has had further communication with the FDA regarding the company's IND and development plans for imetelstat.
The Myelofibrosis IST ceased enrolling patients in January 2014. Under Geron's sponsorship, the patients remaining in the study - which include patients with myelofibrosis (MF), blast phase MF, and refractory anemia with ringed sideroblasts, a subtype of the myelodysplastic syndromes (RARS-MDS) - will continue to receive treatment with imetelstat or continue in follow-up. Geron does not intend to enroll additional patients in this study. The company plans to use the transferred data and information from the Myelofibrosis IST to inform the design of Geron's planned Phase 2 clinical trial in MF.
These developments will be discussed during Geron's second quarter conference call to be held on Monday, August 11, 2014, at 4:30 p.m. Eastern Time. Information for participating in the conference call is available on the company's website at www.geron.com.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that the Company's second quarter 2014 financial results will be released after market close on Wednesday, August 13, 2014.
Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of bone graft material and coatings for medical applications, today announced the completion of its previously announced underwritten public offering of 1,143,000 shares of its common stock at $5.70 per share and warrants to purchase 571,500 shares of its common stock at an exercise price of $7.12 per share to the public.
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in Circulating Tumor Cells (CTCs) and Circulating Tumor DNA (ctDNA) biomarker analysis, today announced that Amy McNeal has joined the Company as Senior Director of Managed Care and Reimbursement Strategies.
Capstone Therapeutics (OTCQB:CAPS), will hold a conference call and webcast on Thursday, August 14, 2014 at 4:30 pm EDT.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced the dosing of the first dialysis patients in a Phase II trial of an intravenous formulation of its peripherally-selective kappa opioid agonist, CR845, for the treatment of uremic pruritus.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the second quarter ended June 30, 2014.
Codexis, Inc. (Nasdaq:CDXS), a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced its financial results for the second quarter ended June 30, 2014.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today reported financial results for the second quarter and six months ended June 30, 2014.
The Cooper Companies, Inc. (NYSE:COO) today announced that effective August 6, 2014, it has completed its previously announced acquisition of Sauflon Pharmaceuticals Ltd., a European manufacturer and distributor of soft contact lenses and solutions, for a purchase price of approximately $1.2 billion.
DS Healthcare Group, Inc. (NASDAQ: DSKX), a leading developer of personal care products and specialty pharmaceuticals, announced today it has signed a distribution agreement with Drogaria Venancio, a leading Rio de Janerio-based pharmacy chain. Drogaria Venancio will sell DS Healthcare's clinically proven personal care products including its Revita and Spectral hair re-growth and hair care products.
Federico Pignatelli, a Director and former Chief Executive Officer of BIOLASE, Inc. (Nasdaq:BIOL), today sent a letter to his fellow BIOLASE stockholders.
Islet Sciences, Inc. (OTCQB:ISLT), a biopharmaceutical company developing new medicines and technologies for the treatment and diagnosis of metabolic disease, announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled, "Lisofylline Analogs and Methods for Use."
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today reported its financial results for the second quarter of 2014.
LHC Group, Inc. (Nasdaq:LHCG), a national provider of home health, hospice and comprehensive post-acute healthcare services, today announced its financial results for the three months and six months ended June 30, 2014.
MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that Scott Koenig, M.D., Ph.D., President and CEO will present at the Wedbush 2014 Life Sciences Management Access Conference.
Mesa Laboratories, Inc. (Nasdaq:MLAB) today reported a 46 percent increase in revenues for the first quarter ended June 30, 2014.
Nature's Sunshine Products, Inc. (Nasdaq:NATR), a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today reported its financial results for the second quarter ended June 30, 2014, and declared a quarterly cash dividend of $0.10 per share.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today reported its financial results for the second quarter and six months ended June 30, 2014.
Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant imaging solutions for use in surgical and diagnostic procedures, announced today that President and CEO, Dr. Arun Menawat, will present the Company's corporate overview at the Canaccord Genuity 34th Annual Growth Conference on Thursday, August 14, 2014 at 1:00 p.m. Eastern Time.
Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that financial results for the Company's second quarter ended June 30, 2014 will be released on Wednesday, August 13, 2014.
OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral fluid diagnostics, today announced its consolidated financial results for the three and six months ended June 30, 2014.
SANUWAVE Health, Inc. (OTCQB:SNWV) today reported financial results for the three and six months ended June 30, 2014 and provided a business update.
TriVascular Technologies, Inc. (Nasdaq:TRIV) today reported financial results for the three and six months ended June 30, 2014.
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that Shalini Sharp, the company's Chief Financial Officer, will be presenting at the Wedbush PacGrow Life Sciences Management Access Conference on August 13, 2014 at 3:40pm ET in New York and at the Canaccord Genuity Growth Conference on August 14, 2014 at 10:30am ET in Boston.
Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of acute liver failure, today announced financial results for the second quarter ended June 30, 2014, and provided an update on recent operations.
Vitacost.com, Inc. (Nasdaq:VITC), a leading online retailer of healthy living products, today reported financial results for the second quarter ended June 30, 2014.