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TOPIC: Caladrius (formerly:Neostem, also) with RS

Caladrius (formerly:Neostem, also) with RS 28 Jul 2016 13:34 #7506

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BASKING RIDGE, N.J., July 27, 2016 — Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces today that as of 5:00 p.m., Eastern Time, on July 27, 2016 it will effect a 1-for-10 reverse stock split of its outstanding common stock, which will be effective for trading purposes as of the commencement of trading on Thursday, July 28, 2016. At the Annual Meeting of Stockholders held on June 22, 2016, the reverse stock split was approved by the Company’s stockholders, to be effected at the Board’s discretion within the approved parameters, and the specific ratio was subsequently approved by the Company’s Board.


NeoStem used to be a lot of things- today it is only the GMP cell manufacturing business of PCT, which stands its own with the likes of Lonzo and others and two product candidates.

First- a very very early Treg immunology product from blood against Type 1 and secondly,the good old CD 34+ therapy which development is stopped in the US but is knocking on the door in Japan in respect of CLI - chronic limb ischemia or PAD.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Caladrius (formerly:Neostem, also) with RS 28 Jul 2016 13:39 #7508

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This is what Caladrius says on the Japanese opportunity:

Caladrius plans to develop its product candidate, CLBS12, in Japan under Japan’s regenerative medicine law only with a partner. This law enables an expedited path to conditional approval for regenerative medicine products that show sufficient safety evidence and signals of efficacy in a phase 2 study. The program is supported by three previous independent studies of autologous CD34 cells in no-option CLI patients. Caladrius has recently completed consultations with the Japanese regulatory authorities on a Phase 2 CLI protocol.


The partner is not there (yet), but it is worthwhile to look at the protocol they agreed with the authorities....

Description :Prospective, open label controlled, randomized, multicenter study in patients with no-option CLI

Dosage:Up to 106 autologous G-CSF-mobilized peripheral blood-derived CD34+ cells/kg per affected limb

Study Size: 35 subjects

Primary Endpoint: Time to continuous CLI free status

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Caladrius (formerly:Neostem, also) with RS 28 Jul 2016 13:54 #7509

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As a reminder (# 231 LOL) in September 2012 Cytori issued this news release and Hedrick recently reminded on the study in New York (March 2016?) for unknown reasons... :whistle: Anyway- this should be completed now and the size- 40 patients from JAPAN- should be sufficient for conditional approval.

The study will investigate the use of patients’ own adipose-derived stem and regenerative cells (ADRCs) processed by the Celution® System for peripheral artery disease (PAD) or arteriosclerosis obliterans (AO). PAD or AO are common circulatory problems in which narrowed arteries reduce blood flow to the limbs. The principal investigator will be Toyoaki Murohara, M.D., Ph.D., Professor and Chairman, Department of Cardiology at the primary trial center, Nagoya University Graduate School of Medicine. The trial will include two additional Japanese sites. “It has been reported by many researchers domestically (Japan) and overseas that transplantation of ADRCs stimulates vascularization of an ischemic area,” said Dr. Murohara. “Specifically, positive clinical results were reported with regards to the treatment for ischemic heart failure in Europe using ADRCs. Although Japan has lagged far behind in this field, I believe that approval by MHLW under the new clinical research guidelines to study ADRCs for limb ischemia is a big step for medical care of vascularization therapy in Japan.”
This multi-center, single arm study will enroll up to 40 patients with peripheral artery disease, Burger’s disease, or with severe limb ischemia caused by connective tissue disease. Each patient will receive an injection of their own ADRCs into the skeletal muscle at the affected area on the limb. Patients will undergo follow-up examinations at one week and at one, three and six months with primary endpoints of safety and limb salvage rate as compared to conventional treatment.


This could turn the tide once and for all... :bye:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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