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TOPIC: Lonza to produce for Tigenix in US

Lonza to produce for Tigenix in US 21 Feb 2015 07:44 #3463

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Tigenix - the Belgium Company developing therapies with allo cultured fat cells signed ab agreement with LONZA to produce the cells in the US for their Phase III (of course- cultured cells are always a DRUG in the US).

Same procedure as Cytori with scleroderma- because of the safety profile and results of earlier European trials- the FDA allows Tigenix to go straight into a pivotal P III with a special protocol.

And now the indication: Perianal Fistulae after Crohn´s :KO:

Same indication for which Cytori has approval in Europe since 2010. :bash:

Cx601 is a locally-injected suspension of allogeneic expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in Crohn’s disease patients, currently in Phase 3 of clinical development in Europe. Following the positive feedback received at a meeting with the Center for Biologics Evaluation and Research within the US Food and Drug Administration (FDA), TiGenix is moving ahead with the development of Cx601 for the US market. To supply Cx601 for a Phase 3 trial in the US, and potentially for the US market when the product has been fully approved, TiGenix has chosen to partner with Lonza as its contract manufacturing organization (CMO). TiGenix will begin the process of technology transfer to Lonza in the coming weeks.


Link to news: Lonza deal
The following user(s) said Thank You: mtpinman, ruedhajan, rongside

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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:

Lonza to produce for Tigenix in US 21 Feb 2015 23:55 #3464

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fas wrote: Same indication for which Cytori has approval in Europe since 2010. :bash:


That actually makes me mad. Did it work?

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Lonza to produce for Tigenix in US 22 Feb 2015 03:31 #3465

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CC's mistaken focus on cosmetic surgery and breast reconstruction in the EU has cost us dearly. They chose the wrong indication. It is what it is.

The key question is, is the allogeneic option more clinically effective than the autologous gemisch generated by the Celution device? Also of importance is how much is the allogeneic option going to cost to manufacture? No doubt the allogeneic option is the one preferred by the patient from a convenience point of view but given the serious side effects of non healing wounds the paramount objective is to utilize the most effective option.

I do not know the actual composition of the Tigenix product. It may be primarily composed of some, not all the shares in the SVF. This is the basis for different efficacy capabilities between the two treatments.

It is unfortunate that we have not progressed further in this indication but Tigenix's success should not necessarily be construed as a negative for CYTX. Approval by the FDA should help the regenerative space.

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Lonza to produce for Tigenix in US 22 Feb 2015 10:06 #3466

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Fas...Cytori just trying to get something over the finish line at this point and get the funds to stay in business.

I know the fistula indication is near and dear to your heart as what seemed to be a obvious missed opportunity but if I dare to pull from JK's latest note...at least they seem "focused" for now.
Their refusal to address simple questions on the matter does raise suspicions that somehow they screwed it up. :cry:

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Lonza to produce for Tigenix in US 22 Feb 2015 12:47 #3468

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That actually makes me mad. Did it work?


Contrary maybe to general knowledge, device claims and approvals are provided ONLY by regulatory agencies when the therapy is considered safe AND has shown efficacy in clinical trials. :KO:

The indication IS important since it combines the important properties of ADRCs of immune regulatory, anti- inflammatory and healing propensitories. I described its emergence and development on this site in the app section and still believe it will come someday.

Even in Japan some patients were treated in the non-Crohn´s fistulae indication which is most likely to be pursued there in view of Europe and the US will most likely be Tigenix´s (am a shareholder of Tigenix too)

Anyway- no Cytori never issued results- but in private conversations CC provided me with an approx. 70% closure of the fistula tract after one year with patients treated. That is good- beats standard of care by a mile and Tigenix also, according to the below:

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASCs) delivered locally through intra-lesional injection. Cx601 is being developed for the treatment of perianal fistulas in Crohn’s disease patients. Crohn’s disease is a chronic inflammatory disease of the intestine and patients can suffer from complex perianal fistulas for which there is currently no effective treatment. In 2009, the European Commission granted Cx601 orphan designation for the treatment of anal fistulas, recognising the debilitating nature of the disease and the lack of treatment options. In a Phase II clinical trial, Cx601 showed efficacy at 24 weeks in 56% of treated fistula tracts, which is more than two times higher than the current standard of care (TNF inhibitors). Efficacy was measured as the complete closure and re-epithelisation of the fistula being treated with an absence of drainage. Additionally, 69.2% of patients demonstrated a reduction in the number of initially draining tracts. The trial also confirmed the safety of the use of allogeneic stem cells for the treatment of perianal fistula. Based on these results, TiGenix sought scientific advice from the European Medicines Agency (EMA) on the future development path of Cx601. TiGenix then initiated a randomised, double-blind, placebo-controlled Phase III trial in Europe and Israel designed to comply with the requirements laid down by the EMA. This pivotal study is intended to enable filing for marketing authorisation in Europe and to serve as a key supportive study in filing for approval in other territories, including the US. The study’s primary endpoint is remission of the fistulous disease, defined as 100% healing of the tracts. The trial has a first complete analysis of results at 24 weeks, with a follow-up analysis to be performed at 52 weeks post-treatment. Evaluation of healing includes both clinical assessment and MRI confirmation (lack of abscesses larger than 2 cm²). Recruitment of the whole sample of patients was completed in the fourth quarter of 2014. The first clinical report is expected to be available in the third quarter of 2015. With positive results, TiGenix intends to submit a request for marketing authorisation with the EMA early in 2016. TiGenix is preparing to develop Cx601 for the US market. The company intends to appoint a contract manufacturing organisation (CMO) in the US with whom it will then begin the technology transfer to enable production of Cx601 in the US; and the company will file for a Special Protocol Assessment (SPA) from the Food and Drug Administration (FDA) to ensure that the design of a new Phase III study to be run in the US is aligned with the Agency’s requirements for future approval of Cx601.

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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:

Lonza to produce for Tigenix in US 22 Feb 2015 16:27 #3471

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I see. Reason I am angry: I think I could have used this two years ago.

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