CEL-SCI’s 2014 Patient Enrollment Increases Eight-Fold Over 2013; Isis Pharma Announces Collaboration With Janssen for Autoimmune Diseases Print E-mail
By Marilyn Mullen   
Monday, 05 January 2015 20:13
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 5, 2015.
CEL-SCI Corporation (NYSE MKT: CVM) announced in 2014 it enrolled close to 200 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). This annual enrollment represents an eight-fold increase over enrollment of 24 patients in 2013, the year during which CEL-SCI dismissed its prior clinical research organization (CRO) and replaced it with new CROs, Aptiv and Ergomed. Twenty one (21) patients were enrolled in the study during the month of December.

“During 2014 we enrolled more patients than we did in several years when we worked with our prior CRO. As we continue to work with our new CROs, we expect strong continued growth in monthly and quarterly patient enrollment for the balance of 2015,” stated CEL-SCI Chief Executive Officer Geert Kersten.

A total of 880 patients are expected to be enrolled through approximately 100 clinical centers in about 20 countries by the end of 2015 in the world’s largest Phase III trial for head and neck cancer. 328 patients have been enrolled in the study by the end of December, 2014.


 
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Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced the company has entered into a global collaboration with Janssen Biotech, Inc. (Janssen) to discover and develop antisense drugs to treat autoimmune disorders of the gastrointestinal (GI) tract.  The collaboration brings together Isis' RNA-targeted technology platform and the expertise of Janssen in autoimmune disorders and therapeutic formulation to discover and develop antisense drugs that can be locally administered, including oral delivery, to treat autoimmune disorders in the GI tract.

"We are excited to be working with Janssen to apply our drug discovery and development efforts in this therapeutic area.  This collaboration broadens the utility of our drug discovery technology to new targets in the GI tract and expands the administration of antisense drugs to local delivery, including oral delivery, to the gut," said B. Lynne Parshall, chief operating officer at Isis Pharmaceuticals. "We are the leader in RNA-targeted therapeutics and our innovation and the successes of our pipeline drugs enable us to form collaborations, like this one, with leaders in specific therapeutic areas.  This partnering strategy ensures that we have access to resources that support and enhance our drug discovery efforts and also provides us with collaborators, like Janssen, who are uniquely capable of conducting development, marketing and commercial efforts for these drugs."

Under the terms of the agreement, which covers three programs, Isis will receive $35 million in upfront payments, including a payment to initiate human  lead optimization on the first collaboration target.  Isis is eligible to receive nearly $800 million in development, regulatory and sales milestone payments and license fees for these programs.  In addition, Isis will receive tiered royalties that on average are double-digits on sales from any product that is successfully commercialized.  Janssen has the option to license a drug from each of the programs once a development candidate is identified. If Janssen exercises its option, it will assume global development, regulatory and commercialization responsibilities.


 
Also Monday:


 
Advaxis, Inc.(Nasdaq:ADXS)
, a clinical-stage biotechnology company developing cancer immunotherapies, today announced that it submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) to conduct the first-in-human study of ADXS-HER2 (ADXS31-164) for the treatment of HER2 expressing solid tumors.

Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, announced today that the company will participate in the 33rd Annual J.P. Morgan Healthcare Conference being held in San Francisco.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that an Investigational New Drug application (IND) to conduct Phase 2 clinical testing of NS2 for the treatment of Sjögren-Larsson Syndrome (SLS) was submitted to the United States Food and Drug Administration (FDA) on December 30, 2014.

Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR)
, a clinical-stage biopharmaceutical company, announced today that it has commenced a public offering of 4,000,000 shares of its common stock.

Alliqua BioMedical, Inc. (Nasdaq:ALQA)
, a provider of advanced wound care products, today announced that it has signed a group purchasing agreement for regenerative skin grafting products with Premier, Inc.

Amedica Corporation (Nasdaq:AMDA)
, a biomaterial company that develops and commercializes silicon nitride ceramics, today released the results of its CASCADE study, a blinded, randomized clinical trial that compared outcomes of spinal fusion surgery between its composite silicon nitride spacers manufactured with a central core of cancellous structured ceramic (CsC), to the gold standard, i.e., PEEK (polyether ether ketone plastic) spacers filled with bone autograft.

Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX)
, a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, today announced that Pratik Shah, Ph.D., President and Chief Executive Officer, will present at the J.P. Morgan Healthcare Conference on Monday, January 12, 2015 at 11:30 a.m. PST at the Westin St. Francis in San Francisco.

Avalanche Biotechnologies, Inc. (Nasdaq:AAVL)
, a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today announced that it filed a registration statement on Form S-1/A with the Securities and Exchange Commission relating to a proposed public offering of 2,000,000 shares of its common stock.

BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX)
, a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced the appointment of Ms. Lynne Powell to the role of Senior Vice President and Chief Commercial Officer at BioCryst, effective January 26, 2015. 

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today that its CLIA-certified, CAP-accredited reference laboratory has received licensure from the California Department of Health.

CareDx, Inc. (Nasdaq:CDNA)
, a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non‐invasive surveillance solutions for transplant recipients, today announced the appointment of Dr. John J. Sninsky, Ph.D., as Chief Scientific Officer. 

CAS Medical Systems, Inc. (Nasdaq:CASM)
, a leader in medical devices for non-invasive patient monitoring, announces the appointment of Paul Molloy to the Company's Board of Directors. Mr. Molloy's appointment increases the size of the CASMED Board to six Directors.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company with industry-leading expertise in the development of cardiovascular gene therapy, today announced that it has conducted initial scale up of its viral manufacturing process for MYDICAR (AAV1/SERCA2a) to commercial scale.

Cempra, Inc. (Nasdaq:CEMP)
, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced its intention to offer and sell shares of its common stock with an aggregate public offering price of approximately $100 million in an underwritten public offering pursuant to its existing shelf registration statement.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT)
, a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that it will report top-line results from three clinical trials in subjects with varying degrees of organ impairment – the company's Phase 2 trial in patients with acute-on-chronic liver failure (ACLF), Phase 1 trial in patients with mild, moderate and severe hepatic impairment, and Phase 1 trial in patients with severe renal impairment – after the market close on Thursday, January 8, 2015.

Cutera, Inc. (Nasdaq:CUTR)
, a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, today announced preliminary revenue for the fourth quarter of 2014 of approximately $25.5 million.

Emergent Health Corp. (Pink Sheets:EMGE)
announced today the appointment of three new members to its Board of Directors. Joining the Board of Directors are David P. Jones, Ph.D., M. Scott Maguire, MBA, and Robert S. McCoy, Jr. "We are delighted to announce the addition of our three newest Board members.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, announced today that John McDermott, Chief Executive Officer, is scheduled to present at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health, home care, hospice care, assisted living and urgent care companies, announced today that it had acquired Alarys Home Health, a Medicare and Medicaid certified home health agency located in Scottsdale, Arizona.

ERBA Diagnostics, Inc. (NYSE MKT:ERB)
Chief Executive Officer, Mohan Gopalkrishnan, will present a business overview and update at the OneMedForum investor conference on Monday, January 12th, 2015 at 2:40 pm PST (5:40 pm EST).

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, announced today that it plans to offer up to $75,000,000 of shares of its common stock in an underwritten public offering.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that it has received notice from the U.S. Food and Drug Administration (FDA) designating as a Fast Track development program the investigation of sacituzumab govitecan, the Company's lead antibody-drug conjugate (ADC), for the treatment of patients with triple-negative breast cancer (TNBC) who have failed prior therapies for metastatic disease.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced that it will present at the 33rd Annual J.P. Morgan Healthcare Conference.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospital medicine and post-acute physician group practice company, announced today that it has changed its name to IPC Healthcare, Inc.

Kips Bay Medical, Inc. (OTCQB:KIPS)
, a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting, or CABG, surgery, today announced that the Company has reorganized its operations by eliminating staff positions, instituting salary reductions and reducing its non-clinical related operating expenses, in order to conserve its capital while it pursues the completion of its current eMESH I clinical feasibility trial.

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today announced that it has named Hollings C. Renton to its Board of Directors.

Metabolix, Inc. (Nasdaq:MBLX)
, an advanced biomaterials company focused on sustainable solutions for the plastics industry, today announced that it received a positive determination from the Nasdaq Stock Market on January 5, 2015 granting approval of the Company's request to transfer its listing to the Nasdaq Capital Market from the Nasdaq Global Market.

Minerva Neurosciences, Inc. (Nasdaq:NERV)
today announced that results from a Primomed (use of PRIMate MOdels to support translational MEDicine) non-human primate study showed that treatment with an analog of MIN-301, the company's investigational neuregulin-1 compound, resulted in improvements in a range of symptoms associated with Parkinson's disease in primates.

Myriad Genetics, Inc. (Nasdaq:MYGN)
announced today that Peter D. Meldrum, president and CEO of Myriad Genetics, is scheduled to present at the J.P. Morgan 33rd Annual Healthcare Conference at 9:30 a.m. Pacific on January 12, 2015, at the Westin St. Francis in San Francisco, California.

Natus Medical Incorporated (Nasdaq:BABY)
today announced that Jim Hawkins, President and Chief Executive Officer and Jonathan Kennedy, Sr. Vice-President and Chief Financial Officer, will present at the J.P. Morgan 33rd Annual Healthcare Conference.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the development and manufacturing of cell therapy products and regenerative medicine, today announced the appointments of David J. Mazzo, PhD as Chief Executive Officer (CEO) and Robert S. Vaters as President and Chief Financial Officer (CFO).

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced dosing of the first patient in its anti-DLL4/VEGF bispecific antibody (OMP-305B83) Phase 1a clinical trial.

Pacific Biosciences of California, Inc., (Nasdaq:PACB)
provider of the PacBio® RS II Sequencing System, today announced its participation in the International Plant & Animal Genome (PAG) XXIII Conference taking place in San Diego from January 10-14.

Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
, announced today the Company's newly implemented strategy for accelerated growth.

Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
, announced today that Moshe Manor, the Company's President and Chief Executive Officer, will present a corporate overview at the 33rd Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2015 at 11:30 AM PT.

QLT Inc. (Nasdaq:QLTI) (TSX:QLT)
today announced that Mr. Glen Ibbott has been appointed as the Interim Chief Financial Officer of the Company effective January 26, 2015, the resignation date of the Company's current Chief Financial Officer.

RedChip Companies, Inc.
, an international small-cap research, investor relations, and media company, today announced that "The RedChip Money Report: Small Stocks Big Money"™ television program host Dave Gentry interviewed Raymond F. Akers, Jr. PhD, Co-founder and Executive Chairman of Akers Biosciences (Nasdaq:AKER).

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced selected key milestones and events anticipated in 2015.

Relypsa, Inc. (Nasdaq:RLYP)
, today announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of October 21, 2015 for completion of the review of the New Drug Application (NDA) for the investigational agent Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a specialty biopharmaceutical company developing botulinum toxin products for the use in aesthetic and therapeutic indications, today announced initiation of the BELMONT trial, a Phase 2, Randomized, Double-Blind, DosE Ranging, Active and PLacebo Controlled, Multi-Center Study to Evaluate the Safety and Efficacy and Duration Of Effect of RT002, a BotuliNum Toxin Type A for Injection, to Treat Glabellar Lines, more commonly known as frown lines.

SAGE Therapeutics (Nasdaq:SAGE)
, a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today announced that Jeffrey Jonas, M.D., chief executive officer, is scheduled to present a company overview and update at the 33rd Annual J.P. Morgan Healthcare Conference at 11:30 a.m. PT on Monday, January 12, 2015 at the Westin St. Francis Hotel in San Francisco.

Stereotaxis, Inc. (Nasdaq:STXS)
announced today that it has received 510(k) clearance by the Food and Drug Administration (FDA) for its Vdrive® with V-CAS™ Catheter Advancement System in the U.S., representing the Company's third Vdrive system product to be cleared for market entry.

Steiner Leisure Limited (Nasdaq:STNR)
today announced that the written trading plan for the purpose of repurchasing its common shares in accordance with the guidelines specified under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, which had been adopted by the Company on May 20, 2014, has ended, effective as of December 31, 2014.

Surgical Care Affiliates, Inc. (Nasdaq:SCAI)
will present at the 33rd Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2015.

Symmetry Surgical Inc. (Nasdaq:SSRG)
announced today an exclusive distribution agreement in the United States with neoSurgical Limited for its innovative neoClose® Trocar Port Closure System. Symmetry Surgical's sales representatives in the United States will begin selling the neoClose® System in the first quarter of 2015.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that Emil D. Kakkis, M.D., Ph.D., the company's Chief Executive Officer, will be presenting at the J.P. Morgan 2015 Healthcare Conference on January 13, 2015 at 10:00am PT in San Francisco.





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