|Halozyme Therapeutics Spikes Up Following FDA News; Advaxis, Merck Report Initiation of Enrollment in Phase 1/2 Study of ADXS-PSA|
|By Josh Gee|
|Wednesday, 08 April 2015 23:13|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 8, 2015.
Shares of Halozyme Therapeutics, Inc. (NASDAQ: HALO) opened higher Wednesday following an update on meetings with the FDA. According to the company's press release, it "plans to proceed with a Phase 3 clinical study (Study 301) of its investigational new drug PEGPH20 in patients with metastatic pancreatic cancer."
The company indicated that a design would be used that allows for a potential marketing application "based on either progression free survival (PFS) or overall survival."
CEO Dr. Helen Torley said, "We are encouraged by the FDA's feedback and their willingness to consider a novel primary endpoint such as PFS given the high unmet medical need in high-HA metastatic pancreatic cancer. We are committed to rapidly finalizing the Phase 3 protocol and developing the companion diagnostic regulatory filings required to initiate Study 301."
Halozyme Therapeutics recently traded at $15.06, up 3 percent.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration agreement with Merck, known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1 antibody, pembrolizumab. The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.
Both ADXS-PSA and pembrolizumab are investigational members of a new class of cancer treatments known as immunotherapies that are designed to enhance the body's own defenses in fighting cancer. Preclinical evidence suggests that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response.
"We are excited to be working with Merck. Equally as exciting is the combination potential of our Lm-LLO immunotherapy with Merck's anti-PD-1 immune checkpoint inhibitor," commented Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers."
Under the terms of the agreement, Advaxis and Merck will collaborate to evaluate the ADXS-PSA/pembrolizumab combination as a treatment for prostate cancer. The Phase 1 part of the trial is designed to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab, and the Phase 2 portion will assess the safety and efficacy of the combination. Advaxis will sponsor and fund the study and Merck will provide pembrolizumab. The companies will collaboratively oversee the conduct of the study, which is planned to begin in early 2015. Results from the study will be used to determine the path for further clinical development of the combination.
"Collaborations such as this are an integral part of Merck's strategy to evaluate the potential of pembrolizumab in multiple combinations for a broad range of cancers," said Dr. Eric Rubin, vice president Oncology, Merck Research Laboratories. "We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer."
Athersys, Inc. (Nasdaq:ATHX) announced today that Dr. David Hess, a stroke specialist and Chairman of the Department of Neurology at the Medical College of Georgia Regents University, and the lead principal investigator in the study, will present the preliminary results from its Phase 2 clinical trial administering MultiStem® for the treatment of ischemic stroke.
Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of revolutionary bone graft material, today announced that it received written notice from the staff at NYSE Regulation, Inc. that trading in the company's common stock will be suspended on the NYSE MKT, and the company's common stock will begin trading on the OTCQX(R) marketplace.
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 that new data on its molecular diagnostic surveillance solution AlloMap® and cell-free DNA (cfDNA) will be presented at the 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) being held April 15-18 in Nice, France.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today responded to false statements and allegations made by Pump Stopper on April 7, 2015.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced the Company will host an open house titled "Advancing Solutions to Cancerous and Degenerative Straits" following the China BIO conference in Shanghai on April 17, 2015 beginning at 8:30 a.m. located at the Company's facility at 333 Guiping Road, Building 1, Caohejing High Technology Park, Shanghai, China.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), two subheadings were missing from the text. The subheadings have been added and the updated release follows in its entirety.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, announced today the completion of its previously announced underwritten public offering of 4,025,000 shares of its common stock, including 525,000 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares.
Please note that in the release issued earlier today by CareDx, Inc. (Nasdaq:CDNA), the media briefing and analyst and investor event schedules contained incorrect information when referencing Eastern Time. The corrected information follows: A media briefing, "Further Advancements of Cell-Free DNA as an Important Biomarker for Transplant Recipients – CARGO II and Beyond" will take place on Thursday, April 16th, beginning at 8:00 a.m. PT (11:00 a.m. ET, 5:00 p.m. CEST). Additionally, an analyst and investor event, "The CareDx Cell-Free DNA Program – Updates from ISHLT" will also take place on April 16th, beginning at 8:30 a.m. PT (11:30 a.m. ET, 5:30 p.m. CEST). A live audio webcast for both events will be available on the Investor section of the CareDx website: www.caredx.com. Interested parties may participate by dialing (855) 420-0616 for US-domestic callers or (678) 304-6848 for international callers, please provide Conference ID: 22982776 when asked to be placed into the call.
Express Scripts Holding Company (Nasdaq:ESRX) announced today its intention to release its first quarter earnings on Tuesday, April 28, 2015 after the market closes and will hold its quarterly conference call to discuss first quarter results on Wednesday, April 29, 2015, at 8:30 a.m. Eastern Time (7:30 a.m. Central Time).
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the development of programmed cellular therapeutics for the treatment of severe, life-threatening diseases, today announced that Christian Weyer, M.D., M.A.S., President and Chief Executive Officer, will present at the 14th Annual Needham Healthcare Conference on Wednesday, April 15, 2015 at 12:10 pm EDT in New York, NY.
Lion Biotechnologies, Inc. (Nasdaq:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that data from a metastatic cervical cancer study conducted by the National Cancer Institute (NCI) was published in the Journal of Clinical Oncology in an article titled "Complete Regression of Metastatic Cervical Cancer After Treatment With Human Papillomavirus-Targeted Tumor-Infiltrating T Cells".
Neothetics, Inc. (Nasdaq:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced that George Mahaffey, president and chief executive officer, will present at Needham & Company's 14th Annual Healthcare Conference in New York City on Wednesday, April 15th at 11:20 a.m. ET/8:20 a.m. PT.
Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced Stanley C. Erck, President and Chief Executive Officer, will present at the 14th Annual Needham Healthcare Conference at 8:00 a.m. ET, April 15, 2015 in New York City at the Westin Grand Central Hotel.
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize heat therapy to treat cancer, today announced that the company received clearance from the U.S. Food and Drug Administration (FDA) to market the MicroThermX® Microwave Ablation System (MicroThermX) for the specific indication of laparoscopic ablation procedures using image guidance.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP), a biopharmaceutical company focused on developing and commercializing transformative treatments for people affected by rare and debilitating diseases, today announced the closing of its underwritten public offering of 10,925,000 shares of its common stock at a public offering price of $9.00 per share, which includes the exercise in full by the underwriters of their option to purchase 1,425,000 additional shares of common stock.
Relypsa Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that results from retrospective analyses of a large medical database assessing the use of renin-angiotensin-aldosterone-system inhibitor (RAASi) therapy in patients with chronic kidney disease (CKD) and/or heart failure (HF) will be presented in two posters at the Academy of Managed Care Pharmacy's (AMCP) 27th Annual Meeting and Expo.
TriVascular Technologies, Inc. (Nasdaq:TRIV), manufacturer of the Ovation Prime® Abdominal Stent Graft System, today announced that based on preliminary unaudited financial results, it expects total revenue of approximately $8.0 million for the first quarter of 2015, an increase of 14.1% from the first quarter of 2014. Geographically, revenue in the United States is expected to be approximately $5.5 million, an increase of 19.9% from the first quarter of 2014.
Vericel Corporation (Nasdaq:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that it will present a corporate update at the 14th Annual Needham Healthcare Conference at 4:20 pm Eastern time on Wednesday, April 15, at the Westin Grand Central Hotel in New York.