BioTime Subsidiary Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase 1/2a Clinical Trial of AST-OPC1 in Patients With Cervical Complete Spinal Cord Injury

Dose Escalation Clinical Trial to Test Initial Safety and Activity of AST-OPC1 in Patient Population with the First Indication Targeted for Product Registration -----  FDA Clearance Triggers Definitive Contract Finalization with California Institute of Regenerative Medicine (CIRM) to Begin $14.3 Million in Trial Funding

ALAMEDA, Calif.-- BioTime, Inc. (NYSE MKT:BTX) announced that its subsidiary Asterias Biotherapeutics, Inc. (ASTY) has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury. The approved trial follows the successful completion of the Phase 1 clinical study of the product, and is designed to assess safety and activity of escalating doses of AST-OPC1 in patients with complete cervical spinal cord injuries, the first targeted indication for AST-OPC1 and the first of future product registration clinical trials.

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Kite Pharma Announces Patients With Aggressive Non-Hodgkin's Lymphoma Experience Positive Results After Receiving Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells at the National Cancer Institute (NCI)

Phase 1-2a Clinical Trial Highlights:

  • 12 of 13 Total Evaluable Patients with Advanced B Cell Malignancies Had Complete Remissions (8 Patients) or Partial Remissions (4 Patients) Resulting in a 92% Objective Response Rate
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Advaxis and Merck Form Collaboration to Evaluate Investigational Combination of Two Novel Immunotherapy Candidates for Advanced Prostate Cancer

PRINCETON, N.J., Aug. 25, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (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.

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Roche and InterMune Reach Definitive Merger Agreement

-- Roche to acquire InterMune for $74.00 per share --
-- InterMune's lead product pirfenidone for idiopathic pulmonary fibrosis to expand Roche's respiratory product portfolio --

BASEL, Switzerland, Aug. 24, 2014 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) and InterMune, Inc. (ITMN) today announced they have entered into a definitive merger agreement for Roche to fully acquire InterMune at a price of $74.00 per share in an all-cash transaction.  This corresponds to a total transaction value of $8.3 billion on a fully diluted basis.  This offer represents a premium of 38% to InterMune's closing price on August 22, 2014 and a premium of 63% to InterMune's unaffected closing price on August 12, 2014.  The merger agreement has been approved by the boards of InterMune and Roche.

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Amicus Therapeutics Announces Positive Phase 3 Data From Fabry Monotherapy Study 012

Migalastat Successfully Meets Both Co-Primary Endpoints of Comparability to Enzyme Replacement Therapy (ERT) on Both Key Measures of Kidney Function
Comparability to ERT Also Demonstrated in Important Fabry Disease Biomarker, Plasma Lyso-Gb3
Proceeding with Centralized Procedure for European MAA Submission
Conference Call and Webcast Today at 8:00 a.m. ET

CRANBURY, N.J., Aug. 20, 2014  -- Amicus Therapeutics (FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced positive 18-month data from its second Phase 3 study (Study 012) of the oral small molecule chaperone migalastat HCl ("migalastat") in Fabry patients with amenable mutations. Detailed results of this second Phase 3 monotherapy study are available in a slide presentation that will be shared by the Amicus management team on a conference call today at 8:00 a.m. ET. Please visit http://ir.amicustherapeutics.com/events.cfm.

Read more: Amicus Therapeutics ( FOLD )