Actinium Submits CMC Meeting Request to FDA for Iomab-B; Neurocrine Announces Oral Presentation of NBI-77860 Clinical Trial Data Print E-mail
By William Kent   
Tuesday, 20 January 2015 20:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 20, 2015.
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that it has submitted a request for a CMC (Chemistry, Manufacturing and Control) meeting to the U.S. Food and Drug Administration (FDA) for the company's Iomab-B drug candidate currently undergoing preparations for starting the pivotal Phase 3 trial by the middle of 2015.

The Company expects to obtain further guidance from the FDA that will allow completion of the processes and methods for large scale manufacturing and testing of clinical and commercial grade drug product.

“We are now in the final stages in our preparations to commence the Phase 3 trial for Iomab-B while simultaneously establishing the necessary infrastructure to enable the Company to quickly commercialize Iomab-B, if approved by FDA,” said Kaushik J. Dave, President and
Chief Executive Officer of Actinium Pharmaceuticals, Inc. "We believe input from the FDA will be invaluable as we finalize our proprietary manufacturing processes to support both the clinical trials and

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future commercialization.”
 
About AML -- Acute myeloid leukemia (AML) is an aggressive cancer of the blood and
bone marrow. It is characterized by an uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 18,860 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2014. Patients over age 60 comprise the majority of those diagnosed with AML, with a median age at diagnosis of about 67 years. Treatment approaches in this population are limited because a majority of these individuals are judged too frail and unable to tolerate standard induction chemotherapy or as having disease generally unresponsive to currently available drugs. Elderly, high risk patients ordinarily have a life expectancy of 5 or fewer months if treated with standard chemotherapy, which only about a third of them do because of toxicity. The other two-thirds receive best supportive care, with 2 months survival, according to Oran and Weisdorf (Haematologica 2012; 1916-24).

About Iomab-B -- Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include a single, pivotal Phase 3 clinical study if it is successful. The trial population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.

Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

 

 
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Neurocrine Biosciences (NASDAQ: NBIX)
announced the steering committee of ENDO 2015 has selected the abstract of their recently completed clinical study of NBI-77860 in classic congenital adrenal hyperplasia for an oral presentation on the initial day of the Endocrine Society's 97th Annual Meeting. ENDO is the world's largest endocrinology meeting drawing over 10,000 experts from around the world.  The ENDO 2015 meeting will be held in San Diego from March 5-8, 2015.

"We are pleased to have been selected to hold an oral presentation at the annual meeting of the Endocrine Society and to share the clinical data of NBI-77860 in classic congenital adrenal hyperplasia with the broader scientific community," said Chris O'Brien, M.D., Chief Medical Officer at Neurocrine. "Congenital adrenal hyperplasia is a disease with a significant unmet medical need and NBI-77860 may potentially make an important difference in patients' lives. The ENDO annual meeting brings together the world's thought leaders in endocrinology to discuss the latest advances in the field and we look forward to discussing our clinical results at this meeting."

The oral presentation of the results from the initial clinical study of NBI-77860 for the treatment of classic congenital adrenal hyperplasia will occur at the 97th Annual Meeting of the Endocrine Society on Thursday, March 5, 2015 from 11:30 am to 1:00 pm (PST). The session is entitled "HPA Axis and Adrenal: Receptors to Clinical Impact."

 


Also Tuesday:



 
Advaxis, Inc. (Nasdaq:ADXS)
, a clinical-stage biotechnology company developing cancer immunotherapies, announced today that it will host and webcast its Analyst & Investor Day on Tuesday, February 3, 2015.

Affimed N.V. (Nasdaq: AFMD)
, a clinical-stage biopharmaceutical company developing targeted cancer immunotherapies today announced the appointment of Dr. Martin Treder as Chief Scientific Officer, effective January 1, 2015.

Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L)
, a leading designer and manufacturer of rapid diagnostic screening and testing products, announces the recruitment and deployment of a full-time, pan-U.S. sales and marketing team under the direction of the newly appointed Executive Vice President, Sales and Marketing, John C. Cheneval.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
(Aldeyra), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it has entered into a definitive purchase agreement with a leading financial services company to raise approximately $2.0 million in a private placement of common stock and a warrant to purchase common stock (the Purchase Agreement).

ALR Technologies Inc. (OTCQB: ALRT)
announced that Nipro Diagnostics, Inc. and Nipro Medical Corporation have agreed to participate in a clinical outcomes study to be conducted by ALRT and Hospital Clinico Metropolitano La Florida, one of the largest and most prestigious public hospitals in Santiago, Chile.

Argos Therapeutics Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis® technology platform, today announced that Dr. Charles Nicolette, the company's chief scientific officer and vice president of research and development, will speak at the Personalized Medicine World Conference (PMWC) 2015 to be held January 26-28th at the Computer History Museum in Mountain View, Calif. Dr. Nicolette is scheduled to speak during a session titled "Immunotherapy: New Options for Cancer Treatment," beginning at 9:15am PST on January 27th.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced that it will hold a conference call for investors on Friday, February 6, 2015, at 8:00 a.m. ET.

Biocept, Inc. (Nasdaq:BIOC)
, a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and Circulating Tumor Cells (CTCs), today announced the launch of ROS1 testing on CTCs, which will help physicians identify which of their patients may be receptive to certain drugs for the treatment of non-small cell lung cancer.

Cancer Genetics, Inc., (Nasdaq:CGIX)
an emerging leader in DNA-based cancer diagnostics, announced today the launch of their ExpandDxTM collaborative testing program. CGI's ExpandDx program, which utilizes VENTANA digital pathology technology from Roche, allows community-based hospitals and pathology labs to partner with CGI through remote consultations, and enables access to a broader range of tests that expand the clinical testing capabilities of community labs and hospitals.

CollabRx, Inc. (Nasdaq:CLRX)
announced that it received a letter from the NASDAQ Listing Qualifications Staff indicating that, unless the Company timely requests a hearing before the NASDAQ Listing Qualifications Panel (the "Panel"), the Company's securities would be delisted from The NASDAQ Capital Market due to the Company's non-compliance with NASDAQ Listing Rule 5550(b)(1) (the "Rule").

CNS Response, Inc. (OTCQB:CNSO)
, CNS Response CEO George Carpenter was interviewed in London last week on CNBC World's Squawk Box. Following meetings with both public and private mental health leaders in the UK, Carpenter observed:  "Our militaries, along with national health plans and a growing number of employers are now recognizing the significant future burden of disorders like Depression, Anxiety, and Post-Traumatic Stress. Mental disorders are emerging as the #1 cause of disability in developed countries, which is why CNS Response is seeing such a high degree of interest by employers and public officials."

CombiMatrix Corporation (Nasdaq:CBMX),
a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced the appointment of Karen Warner, RN, as Vice President of Payer Access and Reimbursement.

Enzymotec Ltd., (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-active lipid based nutritional ingredients and medical foods, announced today the initiation of a clinical study to evaluate the long term efficacy of Vayacog® in patients with Mild Cognitive Impairment ("MCI").

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced it has hired Joseph Lasaga as Vice President, Business Development and Alliance Management, reporting to the President and CEO.

Green PolkaDot Box Incorporated (OTC:GPDB)
reports today that sales in all categories through the middle of January are sharply higher than the comparable 2014 period coming in at $210,000.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that sacituzumab govitecan, the Company's lead investigational antibody-drug conjugate (ADC), produces partial response (PR) in some patients with metastatic esophageal and colorectal cancers who had been heavily pretreated.

INC Research Holdings, Inc. (Nasdaq:INCR)
, a leading, global Phase I to IV contract research organization, today announced the promotions of Alistair Macdonald and Michael Gibertini, PhD, to key roles within the C-suite, further positioning the Company for continued growth and reinforcing its focus on therapeutic expertise as a key differentiator in delivering on customer needs.

InterMed Resources and Amedica Corporation (Nasdaq:AMDA),
a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced the signing of a purchase agreement with HealthTrust, a leading group purchasing and total cost management organization that serves nearly 1,400 acute care facilities nationwide.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced the United States Food and Drug Administration (the "FDA") has informed the Company that it had addressed the violations in the warning letter relating to its manufacturing facility in Añasco, Puerto Rico (the "Añasco" facility).

K2M Group Holdings, Inc. (Nasdaq:KTWO)
a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed follow-on public offering of its common stock.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced that it has commenced a $100 million underwritten public offering of shares of its common stock.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
announced that additional analyses were presented on January 16, 2015 from the Phase 3 NAPOLI-1 study of MM-398 (irinotecan liposome injection), also known as "nal-IRI," in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy.

Minerva Neurosciences, Inc. (Nasdaq:NERV)
today announced it has entered into a $15 million debt facility with Oxford Finance LLC (Oxford) and Silicon Valley Bank (SVB).

Myriad RBM, a wholly owned subsidiary of Myriad Genetics, Inc. (Nasdaq:MYGN), today announced that it will assist the Institut Pasteur in a public-private research collaboration to fight the global tuberculosis (TB) epidemic.

NeoStem, Inc. (Nasdaq:NBS)
a leader in the development and manufacturing of cell therapy products and regenerative medicine, announced today that the State of California's Department of Public Health, Food and Drug Branch has completed its review of NeoStem's manufacturing and control processes at its Irvine, California cGMP facility for the production of eltrapuldencel-T (also known as NBS20) and has issued NeoStem a manufacturing license permitting NeoStem to manufacture drugs from this facility, including the manufacture of eltrapuldencel-T for clinical trial use.

PetMed Express, Inc. (Nasdaq:PETS)
today announced its financial results for the quarter ended December 31, 2014. Net income was $4.8 million, or $0.24 diluted per share, for the quarter ended December 31, 2014, compared to net income of $4.5 million, or $0.23 diluted per share, for the quarter ended December 31, 2013, an increase to net income of 5.6%.

Triumph Healthcare Finance, a provider of asset based lending solutions for small to mid-sized healthcare companies nationwide and a member of the Triumph Bancorp, Inc. group (Nasdaq:TBK), today announced the addition of Sandra Woods as Vice President, Business Development.

VBL Therapeutics (Nasdaq:VBLT)
, a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory disease, today announced the nomination of industry veterans Ron Cohen, M.D., and Philip Serlin, C.P.A. to stand for election to the Board of Directors at VBL's extraordinary general meeting of shareholders, scheduled for February 11, 2015.

Versartis, Inc. (Nasdaq:VSAR)
, an endocrine-focused biopharmaceutical company, today announced that it has commenced an underwritten public offering of shares of its common stock and expects to raise gross proceeds of approximately $75,000,000.

Zafgen, Inc. (Nasdaq:ZFGN)
today announced that it has commenced an underwritten public offering of 2,840,909 shares of its common stock.



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