CytRx Announces Publication of Phase 1b/2 Aldoxorubicin; NewLink Genetics Announces Licensing Agreement For Development Of NLG919 Print E-mail
By Marilyn Mullen   
Monday, 20 October 2014 19:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 20, 2014.
CytRx Corporation (NASDAQ: CYTR), announced that a paper, titled "A Phase 1b/2 Study of Aldoxorubicin in Patients With Soft Tissue Sarcoma," has been published online in Cancer, the prestigious, peer-reviewed journal of the American Cancer Society.

The paper discusses results from CytRx's completed Phase 1b/2 clinical trial where 25 patients were enrolled, including 17 patients (68%) with advanced soft tissue sarcoma (STS).  Data from the trial demonstrated that aldoxorubicin administered at its maximum tolerated dose (MTD) of 350mg/m2 showed a substantial increase in median progression-free survival (PFS) in patients with advanced STS (n=13). 

Partial responses (PR) were achieved in 38% of patients and stable disease (SD) was achieved in 46% of patients.  Median PFS was 11.25 months and median overall survival (OS) was 21.71 months.  Notably, 12 of the 13 patients in the MTD dosing cohort had received prior chemotherapy and had experienced either no response or disease progression while on prior therapy.  In addition, patients in this dosing cohort completed a median of 8 dosing cycles, and 9 patients (69%) had a PR or SD lasting ≥4 months. 

Aldoxorubicin was generally well tolerated, with no clinically significant cardiotoxicities and no drug-related deaths.



NewLink Genetics Corporation (Nasdaq: NLNK)
, a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutics to improve treatment options for patients with cancer, announced today that they have entered into an exclusive worldwide license agreement with Genentech, a member of the Roche Group (SIX:RO) (SIX:ROG) (OTCQX:RHHBY), for the development of NLG919, NewLink's IDO pathway inhibitor. The parties also entered into a research collaboration for the discovery of next generation IDO/TDO compounds.

Under the terms of the agreement, NewLink will receive an upfront payment of $150 million. NewLink will be eligible to receive in excess of $1 billion in milestone payments based on achievement of certain predetermined milestones as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech.

Genentech will fund future research, development, manufacturing and commercialization costs. Genentech will also provide research funding to NewLink for support of the research collaboration. NewLink will continue to pursue development activities associated with NLG919 in combination with its novel HyperAcute vaccine platform.

NewLink will retain the option for co-promotion rights for NLG919 and potential next generation IDO/TDO compounds in the U.S. The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

"This alliance enables us to accelerate and expand development of NLG919 while we continue to advance our other promising clinical and preclinical development programs," said Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. "Genentech's oncology development expertise, commercial leadership and history of successful strategic alliances make it an ideal collaborator to bring the potential benefits of NLG919 to patients."

"We are intrigued by the biology of the IDO and TDO compounds and are very interested in the potential to combine them with Genentech's portfolio of novel therapies," said James Sabry, Senior Vice President and Global Head of Genentech Partnering. "We are delighted to have initiated this significant partnership with NewLink. We hope this collaboration will lead to new therapies for people with cancer."

Also Monday:


Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO)
, an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces the grant of an aggregate of 180,000 incentive stock options under the Corporation's Stock Option Plan for its senior executive and management team.

Advaxis, Inc. (Nasdaq:ADXS)
, a clinical-stage biotechnology company developing cancer immunotherapies, today announced that it has appointed David J. Mauro, M.D., Ph.D., as Executive Vice President, Chief Medical Officer of Advaxis.

Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of bone graft material and coatings for medical applications, today announced the launch of a demineralized allograft, 3Demin™ Cortical Fibers.

Cerner (Nasdaq:CERN)
will host more than 11,000 health care industry leaders, practitioners and Cerner associates in Kansas City for the 29th annual Cerner Health Conference (CHC).

ChemoCentryx, Inc., (Nasdaq:CCXI)
, a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today reported data from the Phase III SHIELD 4 clinical trial in Crohn's disease with vercirnon, an inhibitor of the chemokine receptor known as CCR9.

Emergent BioSolutions Inc. (NYSE:EBS)
announced today that the company will be webcasting its presentation at the Credit Suisse 2014 Healthcare Conference in Phoenix, Arizona on Tuesday, November 11, 2014 at 8:00 AM Mountain.

Foundation Healthcare Inc. (OTCQB:FDNH)
, an owner and operator of surgery focused hospitals that facilitate and enhance the surgical experience for surgeons and their patients, announced today it will host an earnings call to discuss the Company's third quarter 2014 financial results at 4:30 p.m. EDT (3:30 p.m. CDT) on Wednesday, October 29, 2014.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, announced  that a federal judge in Delaware has dismissed all claims against Hemispherx and the Sage Group brought by Cato Capital in an order and decision dated September 29, 2014.  

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, has retained Squire Patton Boggs (SPB) to serve as its global government relations team in an effort to help find additional pathways for testing Hemispherx's flagship experimental anti-viral Ampligen® and approved anti-viral (HPV) Alferon® N against the devastating Ebola virus.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that the European Medicines Agency (EMA) has granted orphan drug status for one of the Company's solid-tumor antibody-drug conjugates (ADCs), isactuzumab govitecan, or IMMU-132, for the treatment of pancreatic cancer.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospital medicine and post-acute physician group practice company, announced today that it is continuing its investment in the Mid-Atlantic region of the U.S. with the acquisition of Comprehensive Health Solutions, based in Newtown Square, PA.

K2M Group Holdings, Inc. (Nasdaq:KTWO)
, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced plans to release third quarter of fiscal 2014 financial results after market close on October 29th.

Lion Biotechnologies, Inc. (OTCBB:LBIO)
, a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TILs), today announced that research by chief scientific officer Laszlo Radvanyi, PhD, has been published in the current issue of Journal of Immunotherapy.

Matinas BioPharma Holdings, Inc. (OTCQB:MTNB)
, an emerging biopharmaceutical company focused on the development and commercialization of omega-3 fatty acid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions, announced today that the Company has submitted an Investigational New Drug application (IND) for MAT9001 to the United States Food and Drug Administration (FDA).

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
, announces the signing of an exclusive world-wide, royalty-bearing, non-transferable, License Agreement with BlueOcean Nutrascience Inc. under Neptune's composition and extraction patents covering the production and sale of marine derived oil products containing phospholipids.

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 Collaborative Research Agreement (CRA) with the University of Veterinary Medicine in Vienna, Austria (University).

Ohr Pharmaceutical, Inc. (Nasdaq:OHRP)
, an ophthalmology research and development company, announced today that additional positive clinical data from the IMPACT study were presented at the 2014 American Academy of Ophthalmology (AAO) Annual Scientific Meeting, in Chicago, Illinois.

Pacific Biosciences of California, Inc., (Nasdaq:PACB)
provider of the PacBio® RS II DNA Sequencing System, today announced that its unique Single Molecule, Real-Time (SMRT®) Sequencing technology will be featured in a number of presentations at the 2014 American Society for Histocompatibility and Immunogenetics (ASHI) 40th Annual Meeting taking place October 20-24 in Denver, CO.

PetMed Express, Inc. (Nasdaq:PETS)
today announced its financial results for the quarter ended September 30, 2014. Net sales for the quarter ended September 30, 2014 were $57.6 million, compared to $60.5 million for the quarter ended September 30, 2013, a decrease of 4.8%.

PositiveID Corporation (OTCQB:PSID)
, a developer of biological detection and diagnostics solutions, today announced that its President, Lyle L. Probst, was featured on Hannity on Fox News on Thursday, October 16, 2014, to discuss the Company's Firefly Dx, a point-of-need system designed to quickly detect pathogens such as Ebola in patients and in the environment.

R. R. Donnelley & Sons Company (Nasdaq:RRD)
will visit the Nasdaq MarketSite in Times Square.  October 2014 marks the 150th anniversary of the founding of the RR Donnelley Company by Richard Robert Donnelley in 1864 in Chicago, IL. 

SWK Holdings Corporation (SWKH.OB)
, a life science focused specialty finance company, announced that it established a record date for its rights offering.

Symmetry Medical Inc. (NYSE:SMA)
, a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that it will release third quarter 2014 financial results for the period ending September 27, 2014 before the market opens on Thursday, October 30, 2014. Symmetry Medical will host an accompanying conference call at 8:00 a.m. ET on Thursday, October 30, 2014.

today announced that Jan Turek has been named Chief Executive Officer, effective as of September 22nd, 2014.

TriVascular Technologies, Inc. (Nasdaq:TRIV)
today announced that the Company will release 2014 third quarter financial results after market close on Monday, November 10, 2014.

VG Life Sciences Inc., (OTCQB:VGLS)
a biotechnology company, announces today that one of its scientific advisors, Dr. Richard Tobin, PhD, published data demonstrating that when there is traumatic brain injury (TBI), the body inflicts additional neural damage via the immune system.

"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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