A MHLW-sponsored public comment period for the new regenerative medicine law will be announced soon. During this period, Japanese academics, healthcare industries and citizens can provide feedback on new legislation aimed at regenerative medicine therapies. Cytori is encouraging its customers and key stakeholders to submit feedback to MHLW during the comment period. Following the closing of the public comment period, legislators will review feedback and unveil the final version of the legislation. Cytori will keep investors and other stakeholders appraised of the progress and implementation of the legislation.
The Japanese Diet passed two pieces of legislation in November 2013 that are designed to accelerate the development of regenerative medicine and cell therapies and to create an ‘Early Approval’ process primarily focused on safety. Over the past year, they have continued to refine the legislation, with the intent that the laws will be implemented by November 2014. This legislation includes:
•An amendment of the Japanese Pharmaceutical Affairs Law (J-PAL) to include a specific branch for Regenerative Medicine Products. The revised law will be called the Pharmaceuticals and Medical Devices Act
•New legislation directing the Ministry of Health, Labour and Welfare (MHLW) to adopt new rules and procedures to enable a streamlined, risk-based approval process for cell therapies
With more than a decade of investment in Japan and an established, Tokyo-based subsidiary, Cytori has a strong stake in the implementation of this legislation and has taken a leadership role in coordinating support for and responding to it. Cytori’s Vice President of Global Regulatory Affairs, Mr. Kenneth Kleinhenz, has been recently appointed to the Healthcare Committee of the American Chamber of Commerce in Japan (ACCJ), the largest healthcare lobby group in the country, and has been a key advocate for the new laws. The ACCJ plans to publish a position paper on the legislation this fall. In addition, Cytori is the only foreign-based company that has a designated member of the Board of Directors for the Forum for Innovative Regenerative Medicine (FIRM), who are also providing support for this new legislation. FIRM is a Japanese organization designed to support advances in regenerative medicine and cell therapy by pursuing industry-led partnerships with government entities and promoting business development and commercialization activities to make these innovative therapies available to patients.
A MHLW-sponsored public comment period for the new regenerat
2½ fold increase of overall median survival, that is significant.
aldo is entering the tumor , while doxo is not entering the tumor .
read more carefully. look at my post above.
aldoxorubicin significantly increased survival almost 2½ fold compared to doxorubicin treatment in an xenograft tumor model employing growth of human glioblastoma multiforme (GBM) tumors in mouse brains.
doxorubicin doesnt have survival benefits.
for example : overall median survival with doxorubicin let´s say would be 4 months (the same as placebo) . then aldoxorubicin would have 2½ fold increase of overall median survival, thats about.10 months and this is significant.
- Aldoxorubicin also significantly reduced the number of dividing cells within the tumors and showed a statistically relevant increased expression of apoptosis biomarkers.
- In comparison, doxorubicin did not appear to enter the tumor to any significant degree and showed no efficacy greater than saline in the treatment of these brain tumors
DON`T MIX THIS FACTS:
they didnt say aldo is 2½ fold better than doxo in entering the tumor and the efficacy in the tumor.
They said aldo is 2½ fold better in increased survival.
1. Announce preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in Glioblastoma Multiforme in the coming year.
2.• Initiate a global Phase 2b clinical trial of aldoxorubicin as a second-line treatment for small cell lung cancer (SCLC) in the second half of 2014
3.• Announce OS results from the ongoing global Phase 2b clinical trial of aldoxorubicin as a first-line treatment for STS in the second half of 2014
4.• Expand the oncology pipeline by combining the Company’s novel linker platform technology with additional chemotherapeutic agents
pure nonsense. Biotech index is down and almost all Biotech stocks are down. Opportunity to add.
the hedgefund pack attacking CYTR again to push the pps down so they can cover and load up cheap.
just another smear campaign of these gangsters, imo.
yahoo data is old and not actual. the correct ownership numbers you´ll find on the nasdaq site and on msn money.
Cytori today received U.S. Patent No. 8,771,678 (the ‘678 patent) which covers methods of enriching fat grafts with adipose-derived regenerative cells (ADRCs™) and methods of using ADRC-enriched fat grafts to treat soft tissue defects, including those complicated by radiation trauma.
The ‘678 patent covers extracting and concentrating ADRCs using an automated, closed-pathway system and combining the ADRCs with unprocessed tissue. In addition, the ‘678 patent specifically covers the delivery of such ADRC-enriched fat grafts to the urethral region of a subject, and to other soft tissue defects, including those caused by irradiation or war injury. Additional claims cover further enrichment of the grafts with angiogenic factors, arteriogenic factors, and/or immunosuppressive drugs.
The ‘678 patent complements Cytori’s worldwide patent estate covering methods of creating and delivering ADRC-enriched fat grafts for a range of indications. Overall, Cytori has 67 issued patents worldwide and more than 75 pending applications.
Pearson is part of the Cramer Feuerstein pack, a paid basher, zero credibility.
BIG BOYZ are holding pps down to accumulate more shares, imo. And market correction is here.