Medgenics Share Discussion Threads

[sicilian_kan] 22/11/2010 07:49

Biopump Factor VIII deal extended for a further 6 months. RNS out today.

I sold my £15k on Friday by the way after the presentation was published, for the following reasons:

1. The mid-dose results, though good, were not as good as the low dose results. I think further work perfecting higher doses (multiple biopumps) is required.

2. It was clear from the last Factor VIII release that though they have (excellently) made a biopump producing Factor VIII, they had not met the target dose yet, hence today's RNS giving them another 6 months to do so. Again, this is a temporary set back and not a permanent one.

3. General market sentiment. Bar a £1k punt elsewhere, I am now totally out of shares, until the PIGS situation is resolved. Can see another stock market fall in the near future.

In short, I'm expecting a little pull back in the share price and will probably come back in, in a few months time, subject to news / price.

[sicilian_kan] 19/11/2010 12:43

My understanding is that presentation will be available on the website around the time of the actual presentation later today, which is taking place after close today.

[sicilian_kan] 19/11/2010 07:38

Can't wait for the website to be updated as the results look positive:

"Dr. Besarab will review how the results to date attest to the safety, effectiveness and durability of the EPODURE Biopump as a potential sustained treatment alternative to months of injections of EPO and other ESAs"

[sicilian_kan] 19/11/2010 07:37

American Society of Nephrology Presentation

TIDMMEDG

RNS Number : 4719W

Medgenics Inc

19 November 2010

Medgenics, Inc.

('Medgenics' or the 'Company')

MEDGENICS ANNOUNCES THAT LEADING ANAEMIA EXPERT WILL PRESENT ITS EPODURE STUDY AT AMERICAN SOCIETY OF NEPHROLOGY CONFERENCE

18-21 NOVEMBER 2010 IN DENVER COLORADO

Data will be presented on November 19th in the session titled New Therapeutics Targets to Fight Anaemia

Misgav, Israel and London, UK - November 19, 2010 - Medgenics (AIM: MEDU MEDG), the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, is pleased to announce that its phase I/II study of the use of EPODURE Biopumps in treatment of anaemia caused by renal disease is to be presented on Friday, November 19, at the annual convention of the American Society of Nephrology, one of the largest meetings of nephrologists in the world. The presentation will be given by Dr. Anatole Besarab, of Ford Hospital, Detroit MI - a member of the Company's Strategic Advisory Board and a leading authority in renal anaemia.

The presentation represents data from the continuation of the Company's phase I/II clinical trial using EPODURE. Chronic kidney disease patients suffering from renal anaemia have been investigated for their response to treatment by EPODURE Biopumps. This report includes data from 6 patients who have received the lower dose (20 IU/kg/day) and 6 patients who have been treated with 40 IU/kg/day; 12 patients in total. Dr. Besarab will review how the results to date attest to the safety, effectiveness and durability of the EPODURE Biopump as a potential sustained treatment alternative to months of injections of EPO and other ESAs (erythropoiesis-stimulating agents).

The presentation will be available on the Company's website (www.medgenics.com).

[sicilian_kan] 18/11/2010 17:24

MEDG has started today with a nice couple of tick ups in anticipation.

[jammytass] 18/11/2010 16:41

it will rise very fast on a good rns

[sicilian_kan] 18/11/2010 08:35

Big trade yesterday. 150k at 9.25p mid.

[sicilian_kan] 17/11/2010 19:14

I hope so andrbea, only one more trading day before the news on Friday...

[andrbea] 17/11/2010 15:21

maybe it's the season for pharma updates

look at rene and pym today, medu next?

[sicilian_kan] 14/11/2010 20:51

Header updated

[sicilian_kan] 09/11/2010 12:26

"Medgenics Inc. (LSE:MEDG) proposed to list its shares on NYSE Amex and raise $17.3 million in a financing underwritten by Roth and Maxim. Medgenic's lead candidate, Epodure, is a transdermal biopump implant device that produces erythropoietin (EPO). Epodure is in Phase I/II testing to treat anemia in chronic kidney disease (CKD) patients. Medgenics gained 0.75p to 11.50p on Monday."

[birotop] 09/11/2010 11:33

sicilian - you need to lighten up - my comment was in jest to readers of the mdx board & not posted on this board - keep your nose out - your posts are like your header, a bit too long winded - regards RT

[sicilian_kan] 09/11/2010 08:04

jt, yes, in my view.

[jammytass] 08/11/2010 16:09

once again medg > no movement should the shares be the same price?

[sicilian_kan] 08/11/2010 08:41

Lots more available at:

[sicilian_kan] 08/11/2010 08:36

News on how the Phase IIb trial and Phase III will happen. Key here is that they already have one major US clinical site that has agreed to take part in the Phase IIb trial and it could be converted into a Phase III trial in due course:

"We believe that the phase IIb clinical trial would likely involve 60 to 120 patients, and seek to reproduce similar results to the phase I/II clinical trial in multiple centers (and in more patients), and further seek to test:

· reliable preparation of Biopumps processed in sealed cassettes;
· titration of the administered dose as needed to reach the desired therapeutic effect in each patient, like in intended clinical use, whether increasing dose by addition of further Biopumps, or reducing it via ablation of one of more of those implanted;
· demonstration of same or better maintenance of hemoglobin within specified range; and
· fewer interventions during the specified time interval (currently planning for six-month duration).

Initial discussions with our regulatory advisers indicate it is possible that following successful demonstration of these points in 60-120 patients in the phase IIb clinical trial, such trial could be converted into a broader pivotal phase III clinical trial for product approval. More than one major U.S. clinical site has asked to take part in the planned phase IIb clinical trial, with costs estimated in the $6-10m range. With sufficient funding, we could perform the phase IIb clinical trial on our own, or alternatively, if agreement is reached with an appropriate strategic partner as more of the Phase I/II data comes in, the phase IIb clinical trial could be conducted with such partner under that agreement".

[sicilian_kan] 08/11/2010 08:34

Thanks andrbea, more to come too!

[sicilian_kan] 08/11/2010 08:33

News on the safety side of the Phase I/IIa trial re all 12 patients:

"As of the end of October 2010, 12 patients had been treated: seven at the low dose level of 20 IU/kg/day and five at the mid-dose level of 40 IU/kg/day. The mid-dose was administered after submission and approval of a safety report on the first six patients treated at the low dose. No related adverse events have been reported for any of the treated patients, with the exception of minor, local subcutaneous hematoma (bleeding) seen at the harvest and implantation sites, as can be expected for any invasive procedures dealing with the skin. The hematoma was generally seen to clear up within several weeks for all patients treated. In addition, no immune response to the implanted Biopumps was reported. Because the protein secreted by the implanted Biopumps is the patient's own naturally-produced human EPO and not a foreign substance, no adverse reaction was expected, and none has been noted. Evidence that the Biopumps were not rejected by the patients' immune system is seen in the sustained elevation and maintenance of hemoglobin levels in most of the patients. All of the patient procedures have been well tolerated and no complaints of discomfort have been received".

[andrbea] 08/11/2010 08:31

all good stuff

let's hope the City now gives the share the rating it deserves

[sicilian_kan] 08/11/2010 08:29

If so, that could bring in excellent money in the next 12 months, more on this below:

"Generally, a strategic partner is sought after sufficient Phase I/II data have been gathered to show proof of concept; however, as with hemophilia, we may reach feasibility or partnering agreements at an earlier stage, even before start of preclinical development. For most applications after the completion of phase I/II clinical trials, we would seek to continue clinical development through the product approval stage with a partner or collaborator who provides funding for the development. As a result, we would not be pursuing the regulatory process on our own. However, for some indications we may determine to conduct our own phase IIb clinical trial or even take a product candidate to final the product approval stage without a strategic partner".

[sicilian_kan] 08/11/2010 08:26

Will there be an EPO deal in the medium term, sounds like there could be at the end of Phase I/IIa...

"The demonstration of several months to over 24 months of sustained anemia treatment from a single administration of the EPODURE Biopump in patients with chronic kidney disease has shown that an appropriate administration of the EPODURE Biopump can provide sustained anemia therapy without any EPO injections and represents an unprecedented duration from a single treatment in patients – replacing scores of EPO injections. Assuming continued positive results in our trial, we intend to seek a strategic partner for the license of the EPODURE Biopump

We anticipate taking a similar approach with our INFRADURE Biopump to treat hepatitis C. Subject to receipt of the required regulatory approvals, we intend to commence phase I/II clinical trials of the INFRADURE Biopump for the treatment of hepatitis C in patients prior to the end of 2011. Assuming receipt of successful initial results from such trials demonstrating proof of concept, we would then intend to seek a strategic partner for the license of the INFRADURE Biopump".

[sicilian_kan] 08/11/2010 08:23

A little bit more on the Factor VIII:

"Factor VIII Biopump for the Treatment of Hemophilia

We are in early stage development of a Factor VIII Biopump for use in the treatment of hemophilia. We believe the Factor VIII Biopump represents a potential improved therapy in the treatment of hemophilia, because it would be prophylactic (preventing bleeding) and therefore could reduce the risk posed by bleeding in these patients. The current treatment is primarily to administer Factor VIII by injection after bleeding has already started. We also believe that if the Factor VIII Biopump succeeds in producing sufficient Factor VIII, and in delivering it into a patient's circulation, it would represent a significant step towards rendering the patient's life more normal. It could also provide significant cost savings for treatment of hemophiliacs, in which the cost of Factor VIII injections in a typical hemophilia patient typically exceeds $100,000 per year. The Factor VIII global market was $4 billion in 2009 according to La Merie Business Intelligence, R&D Pipeline News, Top 20 Biologics 2009 (May 10, 2009).

We have successfully developed Biopumps producing active clotting Factor VIII protein in vitro. We believe this is a further confirmation of our Biopump technology as a platform for continuous production of a range of different proteins, by reproducibly producing Biopumps making a new protein, especially Factor VIII which is considered by many to be one of the more challenging of proteins. We are continuing to develop our Factor VIII Biopump to further increase Factor VIII output per Biopump to bring output to target levels thought sufficient to improve blood clotting, if they were administered to patients with hemophilia. We are in advanced discussions with the pharmaceutical company with whom we worked since October 2009 on the research and development of Factor VIII Biopumps regarding the continuation of our collaboration in Factor VIII Biopump development."

[sicilian_kan] 08/11/2010 08:13

Also from the US filing, they have received a (small but not negligible) cash grant from the US government:

"In addition, in November 2010 we were notified that we will receive a cash grant of $244,479 under the U.S. government's Qualifying Therapeutic Discovery Project to further our Biopump research and development program."

[sicilian_kan] 08/11/2010 08:08

Also from the SEC filing, you can see what the funds raised will be use for. Of particular note is that they are going to seek approval with the funds for a US Phase IIb trial. Now what does that suggest about the results of the current trial, due out on 19 Nov:

"The principal purposes for this offering are to fund our product development activities, including clinical trials for our most advanced product candidates, EPODURE and INFRADURE, for patent maintenance fees and intellectual property support and for working capital and other general corporate purposes, which may include the acquisition or licensing of complementary technologies, products or business.

We anticipate using the net proceeds from this offering as follows:

· approximately $ for EPODURE development to include the following:

· completion of the Phase I/II trial, and
· preIND and IND for EPODURE and/or other indications;
· preparations and approval to commence phase 2b (dose ranging clinical trial);
· approximately $ for INFRADURE development in preparation for phase I trial in humans;
· approximately $ for research and development of core technology and other product candidates;
· approximately $ for patent maintenance fees and other intellectual property support; and
· approximately the balance to fund working capital and other general corporate purposes, which may include the acquisition or licensing of complementary technologies, products or business.