|Lipocine Announces First Patient Dosed in Phase 2a Study of LPCN 1111; University of Cincinnati's Comprehensive Head and Neck Cancer Center Joins CEL-SCI’S Phase III Trial|
|By Staff and Wire Reports|
|Tuesday, 27 May 2014 19:27|
Lipocine (Nasdaq: LPCN), a specialty pharmaceutical company, today announced that the first patient has been dosed in a Phase 2a clinical study of LPCN 1111, a novel ester prodrug of testosterone, in hypogonadal males. The primary objectives of the study will be to determine safety, tolerability, single and steady state pharmacokinetics of testosterone following oral administration of LPCN 1111.
"Based on Phase 1 clinical data, we believe that LPCN 1111 has the potential to be a once a day oral testosterone replacement therapy or provide high average testosterone levels while limiting supraphysiological levels with a twice a day dosing regimen," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "We look forward to reporting top-line results from this study in the second half of 2014 which would become the basis for our Phase 2b study in hypogonadal males."
This 12 patient open-label pharmacokinetic study includes a single ascending dose followed by a fixed dose steady state arm in males between the age of 18 and 80, with documented onset of hypogonadism prior to age 65. These subjects must have serum total testosterone < 300 ng/dL based on two blood draws on two separate days. Subjects will receive three escalating single doses of LPCN 1111 followed by a 28 day multiple dose selected based on single dose results. Serum testosterone, dihydrotestosterone, parent ester and dihydrometabolite of the parent ester are analyzed using LC/MS method. Hematology, clinical chemistry, urinalysis, echocardiogram, prostate specific antigen and adverse events are monitored as part of safety assessment.
LPCN 1111 is a next-generation, novel ester prodrug of testosterone, being developed as a possible testosterone replacement treatment. LPCN 1111 uses the Company's Lip'ral technology to enhance solubility and improve systemic absorption. Previous clinical data suggested feasibility of either once or twice daily dosing.
CEL-SCI Corporation (NYSE MKT:CVM) today announced that the University of Cincinnati Cancer Institute is the latest medical center in the U.S. to join its Phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). CEL-SCI’s study is already active in dozens of clinical centers in 12 countries and is expected to expand to a total of 20 countries with an estimated 880 patients to be enrolled by the end of 2015. According to the American Society of Clinical Oncology, head and neck cancers account for about 3% to 5% of all cancers in the United States.
The University of Cincinnati’s Comprehensive Head and Neck Cancer Center offers patient-centered care from a multidisciplinary team that focuses exclusively on treating cancers of the head and neck. This includes cancers of the oral cavity (tongue, jaw, lip, cheek, and hard palate), throat (tonsil, and base of tongue), larynx (voice box), nose and sinus cavity, skull base, salivary glands, thyroid gland and parathyroid gland. The clinical team includes head and neck cancer surgeons, radiation oncologists, medical oncologists, head and neck radiologists, pathologists, speech therapists and experienced head and neck cancer nurses.
Dr. Keith Casper, Co-Director of the Comprehensive Head and Neck Cancer Center, is the Principal Investigator of CEL-SCI’s Phase III trial at the University of Cincinnati. Dr. Casper has been a Head and Neck Surgical Oncologist at UC Health since 2009. He is also an Assistant Professor of Otolaryngology- Head and Neck Surgery at the University Of Cincinnati College Of Medicine.
“The University of Cincinnati Cancer Institute’s Comprehensive Head and Neck Cancer Center is one of the largest centers in its region specialized in head and neck cancer. Dr. Casper is a renowned expert and thought leader in head and neck cancer and we are very pleased to have his participation in our global study,” stated CEL-SCI Chief Executive Officer Geert Kersten.
About Multikine Phase III Study - The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
Analogic Corporation (Nasdaq:ALOG), enabling the world's medical imaging and aviation security technology, today announced preliminary financial results for its third quarter of fiscal 2014 ended April 30. Revenue for the third fiscal quarter is expected to be approximately $124 million.
Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), announced the publication of the Phase 2 study evaluating CPX-351 in newly diagnosed older patients with acute myeloid leukemia (AML) in Blood, the official journal of the American Society of Hematology.
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced that Krisztina Zsebo, Ph.D., President and Chief Executive Officer, will present a corporate overview at the Jefferies 2014 Global Healthcare Conference, being held at the Grand Hyatt Hotel in New York City.
Cerner Corporation (Nasdaq:CERN) today announced that its board of directors approved an amendment to its stock repurchase program on May 23, 2014, at its regularly scheduled Board meeting, authorizing the repurchase of up to an additional $100 million of its common stock.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the completion of an underwritten public offering of 8,395,000 shares of its common stock, including 1,095,000 shares sold pursuant to the full exercise of an option previously granted to the underwriters to purchase additional shares of common stock.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB), announced that on May 13, 2014, the United States Patent Office issued U.S. Patent 8,722,874 titled "Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity" to inventors Carter, et al. and assignee Hemispherx Biopharma, Inc.
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative portable oxygen concentrators used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions, announced today the company is scheduled to present at the William Blair 34th Annual Growth Stock Conference in Chicago.
IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospitalist physician group practice, today announced that Adam Singer, M.D., chairman and chief executive officer, and Jeff Taylor, president and chief operating officer, are scheduled to present at the Jefferies 2014 Global Healthcare Conference at the Grand Hyatt in New York, NY.
Lipocine Inc. (Nasdaq:LPCN), a specialty pharmaceutical company, today announced that the first patient has been dosed in a Phase 2a clinical study of LPCN 1111, a novel ester prodrug of testosterone, in hypogonadal males.
Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced that management will present at the Jefferies 2014 Global Healthcare Conference on Tuesday, June 3, 2014 at 10:00 a.m. Eastern Time at the Grand Hyatt Hotel in New York City.
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, announced today that Dale Schenk, PhD, the Company's President and Chief Executive Officer, will be presenting at the Jefferies 2014 Global Healthcare Conference on Tuesday, June 3, 2014, at 8:00 AM ET.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that it has entered into a definitive merger agreement under which Spectranetics will acquire AngioScore Inc., a leading developer, manufacturer and marketer of cardiovascular, specialty balloons for $230 million in up-front consideration, along with additional contingent commercial and regulatory milestone payments.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced the appointment of Tim Pearson as Chief Financial Officer.