CEL-SCI Enrolls 22 Patients In Phase III Cancer Trial; Geron Announces Removal of Full Clinical Hold on Imetelstat IND Print
By David Fowler   
Monday, 03 November 2014 19:53
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 3, 2014.

CEL-SCI Corporation (NYSE MKT: CVM) announced during the month of October the Company enrolled 22 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 brings the total number patients enrolled in the world's largest Phase III trial for head and neck cancer to almost 300. A total of 880 patients are expected to be enrolled, through 100 clinical centers in over 20 countries.

“To date, our study has been cleared in 17 countries on three continents and we expect to add more clinics across these regions where an increasing number of patients will be enrolled in the coming months and quarters. With 22 patients enrolled in October, we have now set a new record for monthly recruitment following a slower summer recruitment period. We expect this upward trend to continue,” stated CEL-SCI Chief Executive Officer Geert Kersten.

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only. CEL-SCI's Multikine investigational immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of these patients.


 
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Geron Corporation (Nasdaq: GERN) announced today that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on Geron's investigational new drug (IND) application for imetelstat. In addition, the FDA stated that Geron's proposed clinical development plan for imetelstat that is focused on high-risk myeloid malignancies, such as myelofibrosis (MF), is acceptable. The FDA acknowledged that the company does not intend to conduct further studies in, or develop imetelstat for, the treatment of essential thrombocythemia (ET) or polycythemia vera, which is consistent with the company's plans as originally disclosed in April 2013.

To address the full clinical hold, the FDA required Geron to provide follow-up information from imetelstat-treated patients who experienced liver function test (LFT) abnormalities until such abnormalities resolved to normal or baseline. Geron obtained clinical follow-up information from patients in the previously ongoing company-sponsored Phase 2 trials in ET and multiple myeloma (MM). These data were submitted to the FDA as part of the company's complete response. The company's analysis of these data concluded that in the ET trial LFT abnormalities resolved to normal or baseline in 14 of 18 follow-up patients. For the remaining four ET patients, at the time of the data cut-off, three patients showed improvement in LFT abnormalities and one patient had unresolved LFT abnormalities. Currently, two of the remaining four ET patients continue in follow-up. In the MM trial, LFT abnormalities resolved to normal or baseline in all nine follow-up patients. In addition, no emergent hepatic adverse events were reported during follow-up for either study.

The FDA also requested information regarding the reversibility of liver toxicity after chronic imetelstat administration in animals. The company submitted data from its previously conducted non-clinical toxicology studies, which included a six-month study in mice and a nine-month study in cynomolgus monkeys. In these studies, no clinical pathology changes indicative of hepatocellular injury were observed, and no clear signal of LFT abnormalities were identified.

With the lift of the full clinical hold, a multi-center Phase 2 clinical trial in MF is projected to begin in the first half of 2015.

Upcoming Investor Conference -- Geron's management plans to provide an update on the company and development plans for imetelstat at the Stifel Healthcare Conference. The audio and slide presentation will be webcast and is scheduled to occur at 1:50 p.m. Eastern Time on Wednesday, November 19, 2014.

Third Quarter 2014 Financial Results -- For the third quarter of 2014, the company reported a net loss of $9.5 million, or $0.06 per share, compared to $8.3 million, or $0.06 per share, for the comparable 2013 period. Revenues for the third quarter of 2014 were $160,000 compared to $181,000 for the comparable 2013 period. The company ended the third quarter of 2014 with $142.5 million in cash and investments.

Total operating expenses for the third quarter of 2014 were $10.1 million compared to $8.9 million for the comparable 2013 period. Research and development expenses for the third quarter of 2014 were $6.0 million compared to $5.3 million for the comparable 2013 period. General and administrative expenses for the third quarter of 2014 were $4.1 million compared to $3.5 million for the comparable 2013 period. Operating expenses for the 2013 third quarter also included restructuring charges of $116,000 in connection with the company's decisions to discontinue its discovery research programs and close its research laboratory facility in the second quarter of 2013.

The increase in research and development expenses for the third quarter of 2014, compared to the same period in 2013, primarily reflected higher costs for the manufacturing of imetelstat. The increase in general and administrative expenses for the third quarter of 2014, compared to the same period in 2013, was primarily the net result of higher non-cash stock-based compensation expense and increased legal costs associated with the purported securities lawsuits and derivative lawsuit filed against the company, partially offset by reduced patent costs and transaction fees associated with the stem cell divestiture which closed in October 2013.

Interest and other income for the third quarter of 2014 amounted to $91,000 compared to $699,000 for the comparable 2013 period. The decrease in interest and other income for the third quarter of 2014, compared to the same period in 2013, was primarily the net result of a gain on the sale of excess laboratory equipment in connection with the closure of the company's research laboratory facility in 2013, partially offset by higher interest income due to increased cash and investment balances with the receipt of net cash proceeds from the underwritten public offering the company completed in February 2014.

Nine Months Ended 2014 Financial Results -- Net loss for the first nine months of 2014 was $26.7 million, or $0.18 per share, compared to $29.1 million, or $0.23 per share, for the comparable 2013 period. Revenues for the first nine months of 2014 were $1.0 million compared to $1.1 million for the comparable 2013 period.

Total operating expenses for the first nine months of 2014 were $28.3 million compared to $30.7 million for the comparable 2013 period. Research and development expenses for the first nine months of 2014 were $16.4 million compared to $18.1 million for the comparable 2013 period. General and administrative expenses for the first nine months of 2014 were $11.9 million compared to $11.6 million for the comparable 2013 period. Year-to-date operating expenses for 2013 also included restructuring charges of $1.0 million.

The decrease in research and development expenses for the first nine months of 2014, compared to the same period in 2013, was primarily the net result of lower clinical trial expenses with the wind-down of the imetelstat trials in solid tumors and GRN1005 trials in patients with brain metastases and reduced personnel-related and other research costs resulting from previous restructurings and the discontinuation of the company's discovery research programs, partially offset by higher costs for the manufacturing of imetelstat. The increase in general and administrative expenses for first nine months of 2014, compared to the same period in 2013, was primarily the net result of higher non-cash stock-based compensation expense and increased legal costs associated with the purported lawsuits, partially offset by reduced patent costs and transaction fees associated with the stem cell divestiture.

Interest and other income for the first nine months of 2014 was $273,000 compared to $836,000 for the comparable 2013 period. The decrease in interest and other income for the first nine months of 2014, compared to the same period in 2013, was primarily the net result of a gain in 2013 for the sale of excess laboratory equipment, partially offset by an increase in interest income in 2014.


 
Also Monday:


 
Accelerate Diagnostics, Inc. (Nasdaq:AXDX)
, an in vitro diagnostics company dedicated to providing solutions for the global challenge of drug resistant organisms, today announced that it has entered into a research collaboration with the Rapid Antimicrobial Susceptibility Testing Laboratory at the U.S. Centers for Disease Control and Prevention (CDC) to develop tests for the rapid analysis of antibiotic-resistant biothreat agents based on Accelerate's high-speed identification and antibiotic susceptibility testing platform.

Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR)
, a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, autoimmune and inflammatory diseases, today announced the initiation of a Phase 2b clinical trial of ALD403, its antibody therapeutic candidate targeting the calcitonin gene-related peptide (CGRP), for the preventative treatment of chronic migraine.

Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR)
, a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, autoimmune and inflammatory diseases, today provided recent corporate highlights and reported its financial results for the third quarter ended September 30, 2014.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it will issue its financial results for the third quarter and the year to date period ending September 30, 2014 on Monday, November 10, 2014, prior to the market open.

Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR)
, a leader in functional, renewable plant-based proteins, will hold a conference call on Thursday, November 13, 2014 at 5:00 p.m. Eastern time to discuss results for its fiscal second quarter ended September 30, 2014.

Cara Therapeutics, Inc. (Nasdaq:CARA)
, a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that the Company will host a conference call and live audio webcast on Monday, November 10, 2014, at 4:30 p.m. ET to report third quarter 2014 financial results and provide a corporate update.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals, today announced the appointments of Peter Payne as Senior Vice President of Business Development and Corporate Strategy, and Roberto Guzman as Vice President of Corporate Compliance.

Codexis, Inc. (Nasdaq:CDXS)
, a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced the appointment of Pam Cheng to its board of directors. Ms. Cheng is a 17-year veteran of Merck & Co. and is currently serving as President of MSD China, where she has direct responsibility for $1.3 billion in sales and approximately 4,000 employees, covering a wide functional scope which includes commercial, R&D, manufacturing and various business support organizations.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, announced today details for its 2014 investor meeting, which will be held on November 20, 2014 from 5:00 to 7:30 pm ET at the New York Hilton Midtown.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, will report its third quarter 2014 financial results on Monday, November 10, 2014, after the U.S. financial markets close.

FutureWorld Corp. (OTCQB: FWDG)
, a leading provider of advanced technologies and solutions to the global cannabis industry, announces that its wholly-owned subsidiary, FutureLand Properties, LLC, closed on 237 acres in southern Colorado on October 30th, 2014 for the purpose of leasing to licensed Cannabis and Hemp growers. 

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the quarter ended September 30, 2014 and provided a business update.

Health Insurance Innovations, Inc. (Nasdaq:HIIQ), today announced that Mike Kosloske, Chief Executive Officer, and Dirk Montgomery, Chief Financial Officer, of HII will present an overview of the company Wednesday, November 12th at 10:00 a.m. Mountain Standard Time at the Credit Suisse 2014 Healthcare Conference.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, has been informed by USAMRIID scientists that they have in-vitro data indicating that Alferon®, the only multi-species, natural alpha interferon (IFN) commercially approved in the U.S., successfully protected human cells against the Ebola virus.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced that it plans to spin off its Spine business to Integra shareholders on a tax-free basis.

IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT)
today announced the successful completion of a pilot clinical study for INT0036 that demonstrated a significantly improved pharmacokinetic profile against the reference product.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today reported its financial results for the third quarter ending September 30, 2014.

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today announced it will release its third quarter 2014 operating results and will host an investor call and webcast at 4:30 p.m. ET on Monday, November 10, 2014.

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 financial and operating results for the three and nine months ended September 30, 2014.

MannKind Corporation (Nasdaq:MNKD)
today reported financial results for the third quarter ended September 30, 2014.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, has been granted a new patent (U.S. Patent No. 8,858,941) in the United States for OncoMed's anti-DLL4/anti-VEGF bispecific antibody (OMP-305B83) and use of the bispecific antibody in the treatment of cancer.

Portola Pharmaceuticals (Nasdaq:PTLA)
today announced that it will host a webcast and conference call to discuss the Company's financial results for the quarter ended September 30, 2014 and provide a general business overview on Monday, November 10, 2014 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

Prothena Corporation plc (Nasdaq:PRTA)
, a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, today reported financial results for the third quarter and nine months ended September 30, 2014 and provided an update on its lead programs.

Radius Health, Inc. (Nasdaq:RDUS)
announced today the appointment of Dr. Willard H. Dere, to its Board of Directors. Dr. Dere was formerly at Amgen, where he led the development program of Prolia.

Receptos, Inc. (Nasdaq:RCPT)
, a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that Faheem Hasnain, its President and Chief Executive Officer, will be presenting at the Nomura BioPharma Conference at the Mandarin Oriental Hotel in Boston.

RedChip Companies, Inc., today announced it has issued a research profile on OxySure Systems, Inc. (OTCQB:OXYS), a medical technology company that develops, markets, and sells life-saving, easy-to-use medical devices.

Relypsa, Inc. (Nasdaq:RLYP)
, today announced that Scott Garland has joined the company as senior vice president and chief commercial officer. Garland, a seasoned executive with over 20 years of biotechnology and pharmaceutical experience, has extensive expertise in launching products and building commercial infrastructure to support specialty drugs, including within the nephrology community.

StemCells, Inc. (Nasdaq:STEM)
, who pioneered the discovery and development of HuCNS-SC® cells, a proprietary population of highly purified, expandable human neural stem cells and is leading the development of cell based therapies for the treatment of disorders of the central nervous system, today announced that it will host its first investor and analyst event in New York, November 20, 2014.

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 diseases, today announced that principal investigator, Andrew Brenner, MD, will present interim data from VBL's ongoing Phase 2 clinical trial of its lead product candidate, VB-111, for the treatment of recurrent glioblastoma (rGBM), an aggressive form of brain cancer, in an oral presentation at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) in Miami, Florida.

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 diseases, today announced that it will host a conference call and live audio webcast on Thursday, November 13, 2014 at 8:30 a.m. ET to report third quarter 2014 financial results.



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