Pharmacyclics Enters Into Agreement with Roche to Evaluate IMBRUVICA® and GAZYVA®; Infinity Reports Data From Duvelisib Phase 2a Study Print E-mail
By Josh Gee   
Thursday, 16 October 2014 18:39

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 16, 2014.

Pharmacyclics, Inc. (NASDAQ: PCYC) announced it has entered into a master clinical drug supply agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) to evaluate the safety, tolerability and preliminary efficacy of IMBRUVICA® (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, in combination with GAZYVA® (obinutuzumab), a new CD20-directed  antibody that attacks targeted cells both directly and together with the body's immune system, in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). 

Both products are approved and marketed for the treatment of CLL. IMBRUVICA is used to treat CLL in patients who have received one prior therapy, and in CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients. GAZYVA is used with the chemotherapy drug, chlorambucil, to treat CLL in patients with previously untreated chronic lymphocytic leukemia. The use of these products in combination is investigational only.

"We are committed to evaluating the potential activity of IMBRUVICA as a single agent and in combination with other agents to determine the benefits that IMBRUVICA may provide through a variety of uses across several hematologic malignancies," said Bob Duggan, Chairman & CEO, Pharmacyclics. "We look forward to a rewarding and productive partnership with Roche to evaluate our product with GAZYVA in order to deliver new treatment options to patients with NHL and CLL."

The study of the investigational combination of IMBRUVICA and GAZYVA through several investigator-sponsored trials also is being considered.  Additional details of the agreement were not disclosed.


Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
announced encouraging topline data from its Phase 2a exploratory study of duvelisib (IPI-145), its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with mild, allergic asthma. Data from this randomized, double-blind, placebo-controlled, cross-over study demonstrated that duvelisib was well tolerated and met several secondary and exploratory endpoints in an allergen challenge study.

Clinical improvement was observed in the late-phase asthmatic response FEV1 (a standard lung function test that measures the amount of air that can be exhaled in one second) among patients who received duvelisib administered at the highest dose tested, 25 mg twice daily (BID) for five days; however the primary endpoint of the study was not met as it did not reach statistical significance (p = 0.052). Multiple secondary clinical endpoints measuring improvements in lung function following duvelisib administration were achieved with statistical significance and were associated with changes in key cytokines and chemokines involved in the asthmatic response. Taken together, these data demonstrate early proof-of-activity in this allergen challenge study.

“This is the first clinical study to suggest that inhibition of PI3K-delta and PI3K-gamma plays a role in improving lung function for patients with asthma. In this exploratory study, duvelisib showed evidence of activity across several important clinical measures, including improvement in the late-phase asthmatic response and significant corresponding changes in several key mediators of airway inflammation,” stated Julian Adams, Ph.D., president of research and development at Infinity. “These data support further development of PI3K-delta,gamma inhibitors in more severe forms of asthma, for which there is a medical need.”

“In addition to asthma, we are also studying duvelisib for the treatment of rheumatoid arthritis. We expect to report data from ASPIRA, Infinity's Phase 2 study of duvelisib with background methotrexate in patients with moderate-to-severe rheumatoid arthritis, by the end of the year. The results of both clinical studies will inform Infinity's development strategy for its PI3K-delta,gamma program in inflammation,” Dr. Adams continued.


Also Thursday:

Nasdaq (Nasdaq:NDAQ)
announced that trading of Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a drug development company, commenced on The Nasdaq Stock Market on October 16, 2014.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the development of diagnostics and therapeutics for Alzheimer's disease, Parkinson's disease and ophthalmological disorders, announced that it has applied to the US Food & Drug Administration for Orphan Drug Designation for MANF (mesencephalic-astrocyte-derived neurotrophic factor) in retinitis pigmentosa (RP).

Amedisys, Inc. (Nasdaq:AMED)
, one of America's leading home health and hospice care companies, announced today that it will host a conference call to discuss results for the third quarter ended September 30, 2014 on Wednesday, October 29, 2014 at 10:00 a.m. Eastern Time (9:00 a.m. Central Time).

Applied Genetic Technologies Corporation (Nasdaq:AGTC)
, a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced that Sue Washer, AGTC president and CEO is this year's recipient of the [email protected] Innovator Award.

Atara Biotherapeutics, Inc. (Nasdaq:ATRA)
, a clinical-stage biopharmaceutical company focused on developing novel therapeutics for serious unmet medical needs, will visit the NASDAQ MarketSite in Times Square in celebration of its initial public offering (IPO) which will occur today, October 16, 2014.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services and mobile tools for medical groups and health systems, today announced financial and operational results for the third quarter of fiscal year 2014.

In a release issued on Tuesday, October 14th 2014 by Bacterin International Holdings, Inc. (NYSE MKT:BONE), there was an error in the third paragraph. Please note that the final sentence of the third paragraph should read, "We are now starting to realize the benefits of these investments and we expect to see our revenue accelerate during the fourth quarter of 2014 and throughout 2015."

Bio-Path Holdings, Inc. (Nasdaq:BPTH)
, a clinical stage biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, will visit the Nasdaq MarketSite in Times Square.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, announced today that Cigna Corporation will reinstate coverage of the Company's Mobile Cardiac Outpatient Telemetry(TM) service MCOT(TM).

Cellular Biomedicine Group Inc. (Nasdaq:CBMG)
, a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced the launch of a pre-clinical study of human adipose-derived mesenchymal progenitor cell (haMPC) therapy for Chronic Obstructive Pulmonary Disease (COPD).

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today provided an update on the company's R&D programs, including the addition of a potential new product candidate, CMX16669, to its development pipeline.

Cytomedix (OTCQX:CMXI)
, a pioneer in biodynamic therapies, today announced the launch of its new corporate brand identity, Nuo Therapeutics, during The Symposium on Advanced Wound Care (SAWC) Fall Meeting, being held October 16-18, 2014 in Las Vegas, Nevada.

Fiscal 2014 was a remarkable year for Epicore (TSX-V:EBN). Sales records were set in every quarter and net income (without exceptional adjustments) broke the million dollar mark for the first time.

Eternity Healthcare Inc. (OTC:ETAH)
, a medical device and diagnostic company with advanced technologies in Needle-Free Injection systems, announced today that it is developing a multi channel Needle-Free Injection device system for delivery of vaccines intramuscularly.

Harvard Bioscience, Inc. (Nasdaq:HBIO)
, a global developer, manufacturer, and marketer of a broad range of equipment, instruments and solutions to advance life science, will announce results for its third quarter before market trading hours on Thursday, October 30, 2014.

HCI Group, Inc. (NYSE:HCI)
plans to hold a conference call on Thursday, November 6, 2014 at 4:30 p.m. Eastern time to discuss results for the third quarter ended September 30, 2014.

Herborium® Group, Inc.(OTC Pink: HBRM)
, a Botanical Therapeutics® Company and the provider of unique all  botanical medicines (Botanical Therapeutics®)  announced today that its Third Quarter sales for 2014 grew 105% over the same quarter in 2013

Immune Design Corp. (Nasdaq:IMDZ)
, a clinical-stage immunotherapy company, today announced that it has entered into a broad collaboration for the development of a herpes simplex virus (HSV) immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN) and (NYSE:SNY).

Lombard Medical, Inc. (Nasdaq:EVAR)
, a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced the successful completion of the first two EVAR cases performed in New Zealand using its lead product, Aorfix™, an endovascular stent graft for AAA repair.

Macrocure Ltd. (Nasdaq:MCUR)
, a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that Nissim Mashiach, Macrocure's President and Chief Executive Officer will present at multiple upcoming conferences in November.

Natus Medical Incorporated (Nasdaq:BABY)
today announced the launch of the Vista Ultrasound System.

Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ)
, the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced that it has appointed Kirloskar Technologies Pvt., Ltd. ("KTPL"), as the exclusive distributor for the Company's family of fluorescence imaging technologies in India.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company developing cell and gene therapy solutions for the treatment of diseases, announced today that it has entered into a license with the University of Technology in Sydney, Australia (UTS), that grants Nuvilex the worldwide rights to use human insulin-producing cells, termed "Melligen" cells, developed by Prof. Ann Simpson and her colleagues at UTS for the development of a treatment for insulin-dependent (Type 1 or juvenile-onset) diabetes.

PositiveID Corporation (OTCQB:PSID)
, a developer of biological detection and diagnostics solutions, today announced that its President, Lyle L. Probst, was featured on Fox Business' The Willis Report yesterday to discuss how the Company's point-of-need pathogen detection system, Firefly Dx, could be used anywhere to detect Ebola within minutes.

Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT)
, a development-stage oncology and dermatology biopharmaceutical company, announced today that Sanjiv S. Agarwala, MD, of St. Luke's University Hospital and Professor of Medicine at Temple University will present data on its investigational new drug PV-10 for the treatment of melanoma at the 11th International Congress of the Society for Melanoma Research in Zurich, Switzerland.

Relmada Therapeutics, Inc., (OTCQB: RLMD)
, a clinical-stage company developing novel therapies for the treatment of chronic pain, announced today the issuance of approximately 10.1 million of its shares of common stock pursuant to the exercise of A-Warrants originally issued in connection with private placements that closed in May and June 2014.

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today the initiation of its second clinical trial for SL-401, a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of a wide range of hematologic cancers.

Verde Media Group Inc. (OTC:VMGI)
, announces that a new research report validates companies initiatives to develop and produce omega-3 oils high in DHA. Omega-3 oils are mainly derived from marine sources, however through its Verde Media Biotechnology Division ("VMBD") the company is using proprietary technology that utilizes a robust and sophisticated process to produce specialized omega-3 microbes in large volumes at substantially reduced costs.

VG Life Sciences Inc. (OTCQB: VGLS) is a biotechnology company focused on developing treatments for patients suffering from autoimmune and infectious diseases.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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