Lipocine Announces Positive Results In Phase 2a Study Of LPCN; Kite Reports Positive Results With Anti-CD19 Print E-mail
By Josh Gee   
Monday, 13 October 2014 18:51

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 13, 2014.

Lipocine Inc. (LPCN: NasdaqCM), a specialty pharmaceutical company, today announced positive top-line results from a Phase 2a clinical study of LPCN 1111, a novel testosterone replacement therapy ("TRT") candidate, in hypogonadal males. The primary objective of the study was to determine the feasibility of once daily dosing of LPCN 1111 in hypogonadal males.

"We are pleased that the results in the hypogonadal subject population confirmed our Phase 1 findings that LPCN 1111 is a candidate for once daily oral testosterone replacement therapy," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "Additionally, these results, along with our positive top-line efficacy Phase 3 results for our lead asset, LPCN 1021, a twice-a-day oral TRT, are particularly important in establishing Lipocine's leadership in providing "best in class" patient friendly oral TRT options. We believe that oral TRT will significantly increase patient compliance and overcome many of the inconvenience and transference issues associated with today's marketed TRT products."

This open-label, dose-escalating single and multiple dose study enrolled 12 males. These subjects had serum total testosterone < 300 ng/dL based on two blood draws on two separate days. Subjects received doses of LPCN 1111 as a single dose of 330 mg, 550 mg, 770 mg, followed by once daily administration of 550 mg for 28 days in 10 subjects, and once daily administration of 770 mg for 28 days in eight subjects.

Results from this study demonstrated the feasibility of a once daily dosing with LPCN 1111 in hypogonadal men and a good dose response. Additionally, the clinical study confirmed that steady state is achieved by day 14 with consistent inter-day performance observed on day 14, 21 and 28. No subjects exceeded peak serum testosterone concentration ("Cmax") of 1500 ng/dL at any time during the 28 day dosing period on multi-dose exposure. Overall, LPCN 1111 was well tolerated with no serious adverse events.



Kite Pharma, Inc., (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced the publication in The Lancet of clinical results demonstrating the potential to treat relapsed or refractory acute lymphoblastic leukemia (ALL) with an anti-CD19 chimeric antigen receptor (CAR) T cell therapy. Kite's most advanced product candidate, KTE-C19, is an anti-CD19 CAR T cell therapy that involves genetically modifying a patient's T cells to express a CAR that is designed to target CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.

The findings from a Phase 1 clinical trial conducted by the Pediatric Oncology Branch of the National Cancer Institute (NCI) demonstrated that administration of anti-CD19 CAR T cells resulted in a 70% complete response rate in 20 pediatric or young adult patients with relapsed or refractory ALL. Sixty percent of the 20 patients achieved an MRD-negative complete response. Ten of the patients who had an MRD-negative complete response subsequently underwent hematopoietic stem-cell transplantation (HSCT), and all 10 remained disease free with a median follow-up of 10 months. These and other findings from the Phase 1 study are being published in an article titled, "T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial,", which is appearing in the October 13, 2014 issue of The Lancet. Lead author on the article is Crystal L. Mackall, M.D., Head of Immunology Section and Chief of the Pediatric Oncology Branch at the National Cancer Institute.

Gary Schiller, M.D., F.A.C.P., Professor, Director, Hematological Malignancies/Stem Cell Transplantation Unit, David Geffen School of Medicine at UCLA, commented, "This article, the first publication of an intention-to-treat analysis from a completed clinical study of CD19-CAR therapy in pediatric and young adult patients with relapsed/refractory ALL, deepens our understanding of this important investigational approach. The results show that this treatment is feasible in many patients with ALL and can eradicate chemoresistant disease with an acceptable toxicity profile. Further, the findings demonstrate substantially higher response rates than seen in the literature for the most recently approved agent for refractory ALL. CD19-CAR therapy represents a potentially important new tool to address the urgent need for new treatment modalities in these patients."

The open-label, Phase 1 dose-escalation study enrolled patients aged 1-30 years. Prior to the study, all patients had been heavily pretreated for their disease. Patients received a conditioning regimen of chemotherapy (cyclophosphamide and fludarabine) followed by a single infusion of one of two dose levels of anti-CD19-CAR T cells. The CAR-expressing T cells were produced from each patient's own peripheral blood mononuclear cells (PBMCs), modified using a gammaretroviral vector encoding the CAR, as well as a CD28 costimulatory moiety. After the dose-escalation phase, an expansion cohort was treated at the maximum tolerated dose. Pursuant to the study protocol, patients are continuing to be monitored.

As seen in other studies, infusion of anti-CD19 CAR T cells was associated with significant, acute toxicities, including fever, hypokalemia, and transient neurological deficits. All toxicities were fully reversible.

Also Monday:

Alliqua BioMedical, Inc. (Nasdaq:ALQA)
, today announced that an abstract on Alliqua's Biovance® Human Amniotic Membrane Allograft is to receive an award at the Fall 2014 Symposium on Advanced Wound Care (SAWC) to be held at the Caesars Palace Hotel & Casino in Las Vegas, Nevada on October 16-19.

Amedica Corporation (Nasdaq:AMDA), a biomaterial company focused on silicon nitride ceramics as a material platform to develop, manufacture and commercialize novel medical devices, today announced that Max E. Link, Ph.D., its former Chairman of the Board of Directors, passed away unexpectedly at the age of 74.

Amyris, Inc. (Nasdaq:AMRS) will report financial results for the third quarter ended September 30, 2014 after market close on Tuesday, November 4, 2014.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today it will be added to the S&P SmallCap 600 Index and the GICS Life & Health Insurance sub-industry index after the close of trading on Monday, October 20, 2014.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/110,348 (the '348 application).

Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of cell-free circulating tumor DNA (cfDNA) and circulating tumor cells (CTCs), and Rosetta Genomics, Ltd. (Nasdaq:ROSG), a leading molecular diagnostics company advancing microRNA-based diagnostics based on its proprietary microRNA platform technologies, today announced a collaboration that will combine both companies' platform technologies in an innovative approach to cancer diagnostics.

Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, announced today that it has entered into a research collaboration with Columbia University's Azra Raza, MD, director of the MDS Center and assistant professor of medicine at Columbia University Medical Center (CUMC), and Siddhartha Mukherjee, MD, PhD, assistant professor of medicine at CUMC, to identify more accurate diagnostic and prognostic markers for myelodysplastic syndromes (MDS), as well as novel therapies to target this class of bone marrow cancers.

Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced that the Company has successfully secured a contract to provide its cell storage, processing and consumables platform to Upstate Medical University's, Upstate Cord Blood Bank, one of two public blood cord banks in New York State and one of 27 total public cord blood banks in the United States.

Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, will webcast the company's R&D update presentations on Oct. 15, 2014 from 4:30 p.m. to 6:30 p.m. ET.

CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced the continuation of strong positive results for four weeks of monotherapy with its monoclonal antibody, PRO 140, in patients with HIV-1, who are currently participating in the Company's Phase 2b treatment substitution trial.

EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that data on clinical outcomes of its Ablatherm-HIFU FDA study (the "Enlight Trial") will be presented at the 4th International Symposium of the Focused Ultrasound Foundation ("FUSF"), being held October 12-14, 2014 in Washington D.C.

The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced today that it has agreed to purchase nine skilled nursing and assisted living facilities, a home health agency and a private home care business from Shea Family Care, the largest provider of a complete continuum of post-acute healthcare services in the San Diego market.

Richard E. Perlman, Executive Chairman and James K. Price, Chief Executive Officer of ExamWorks Group, Inc. (NYSE:EXAM), will present at the Credit Suisse Annual Healthcare Conference in Phoenix, Arizona, on Wednesday, November 12th at 10:30 a.m. ExamWorks is a leading provider of independent medical examinations (IMEs), peer reviews, bill reviews, Medicare compliance, case management, and related services.

Immunomedics, Inc., (Nasdaq:IMMU) today announced that 7 studies involving the Company's investigational products and technologies will be presented at the 27th Annual European Association of Nuclear Medicine (EANM) Congress, scheduled for October 18 – 24, 2014, in Gothenburg, Sweden.

IRADIMED CORPORATION (Nasdaq:IRMD) announced today that the Company will release its 2014 third quarter financial results before the market opens on Thursday, October 30thth.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced topline results from ITI-007-200, a Phase I/II clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007 in healthy geriatric subjects (trial Part 1) and in patients with dementia, including Alzheimer's disease (trial Part 2).

Intuitive Surgical, Inc. (Nasdaq:ISRG)
today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 72 new employees.

Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced the unveiling of its new ThinkRadial™ website and educational initiative at

Nanosphere, Inc. (Nasdaq:NSPH)
, a company enhancing medicine through targeted molecular diagnostics, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Verigene® Enteric Pathogens Nucleic Acid Test (EP), which now includes additional viral targets, as well as the bacterial and toxigenic targets cleared by FDA earlier this summer.

NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today that the Company has been named one of the fastest growing companies from 2010 to 2013 located in the New York City area according to Crain's New York Business' Fast 50.

Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage biotechnology company developing cell therapy solutions for the treatment of diseases, announced today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its Cell-in-a-Box® treatment for pancreatic cancer. If granted, Orphan Drug Designation in the United States will provide Nuvilex special development and commercial assistance from the FDA, including a 7 year period of marketing exclusivity.

PetMed Express, Inc. (Nasdaq:PETS)
will announce its financial results for the quarter ended September 30, 2014 on Monday, October 20, 2014 at 8:00 A.M. Eastern Time, then at 8:30 A.M. Eastern Time, Menderes Akdag, the Company's Chief Executive Officer and President, will host a conference call to review the financial results.

Rich Pharmaceuticals, Inc. (OTCQB:RCHA)
Rich, a cancer therapeutics development company announced that it has entered into an agreement with Richard L. Chang Holdings, LLC based in New Jersey for ownership to its investigational cancer patent assignment using Phorbol Esters in the treatment of Hodgkin's Lymphoma.

Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
, a global biopharmaceutical company, today announced that clinical data for AMITIZA® lubiprostone will be presented at the American College of Gastroenterology (ACG) 2014 Annual Scientific Meeting on Sunday, October 19, and Monday, October 20, at the Pennsylvania Convention Center in Philadelphia.

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the presentation of results from a Phase 2 extension study of sialic acid extended-release (SA-ER, UX001) tablets in patients with hereditary inclusion body myopathy (HIBM; also known as GNE myopathy), a rare, progressive muscle-wasting disease. SA-ER is designed to replace the deficient sialic acid substrate in patients with HIBM.


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