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IMMU.ST
I know, it sounds preposterous, but if you want to know the future in the treatment of solid tumors, listen to Immunicum's latest presentation!
IMMUNICUM (IMMU.ST) up 100% since I last posted on it here, have you guys taken a position?
If not, the MC is still only $160M so not very expensive for a company with a truly promising "immune primer"!
IRLAB Therapeutics (IRLAB.ST)
For those interested in CNS therapeutics, this Swedish company should definitively be looked at!
Current MC $370M with two Phase II assets in Parkinson with one major inflection point within a month.
This recent presentation is a good start.
Actually, there is already some American interest, New Leaf Venture took a position last year.
Interestingly, they claim their substance IRL790 could be effective in both PD-Dyskinesia and PD-Psychosis.
IMMUNICUM (IMMU.ST)
I have a new Swedish Biotech-company for you guys, Immunicum.
I think this could be an even better investment for me than Hansa..
Current EV approx. $40M!!
This recent company presentation is an excellent start!
Below, a few of the slides for summary
Beware of loparn, he's probably Swedens most (in)famous pump and dump trader!
Thanks, mcbio!
I actually think HMED is very easy to understand, it works and they are alone...
In contrast, I have much more difficulties gauging the merits of the BINV pipeline. As we all know the oncology space is so crowded but I think that with an EV of approx. $45M and three mAb soon in the clinic the r/r in BINV is favorable.
I would very much appreciate some input from you guys about their lead drug BI1206, described in this publication.
Apparently, MGNX pursued something similar but abandoned it, why, and will BINV be successful!?
Cancer Cell. 2015 Apr 13;27(4):473-88
Antagonistic human Fc?RIIB (CD32B) antibodies have anti-tumor activity and overcome resistance to antibody therapy in vivo.
Abstract
Therapeutic antibodies have transformed cancer therapy, unlocking mechanisms of action by engaging the immune system. Unfortunately, cures rarely occur and patients display intrinsic or acquired resistance. Here, we demonstrate the therapeutic potential of targeting human (h) Fc?RIIB (CD32B), a receptor implicated in immune cell desensitization and tumor cell resistance. Fc?RIIB-blocking antibodies prevented internalization of the CD20-specific antibody rituximab, thereby maximizing cell surface accessibility and immune effector cell mediated antitumor activity. In hFc?RIIB-transgenic (Tg) mice, Fc?RIIB-blocking antibodies effectively deleted target cells in combination with rituximab, and other therapeutic antibodies, from resistance-prone stromal compartments. Similar efficacy was seen in primary human tumor xenografts, including with cells from patients with relapsed/refractory disease. These data support the further development of hFc?RIIB antibodies for clinical assessment.
I have two new favorites from my home town Lund, Sweden, Bioinvent (BINV) and Camurus (CAMX). Together with HMED they could very well put Lund back on the track as a pharma-town after the unfortunate closure of one of AZN sites a few years back.
As usual these European companies are substantially undervalued compared to yours but sooner or later they will catch up!
The experts are enthusiastic, anyone listening to this HMED event would like to own the stock!
http://hansamedical.com/en/capital-markets-day/
This is one of the best parts of the investor day, listen at least to Montgomery’s first minute and then at 41 min..
http://cloud.magneetto.com/wonderland/2015_1113_Treatment_And_Prevention_of_ABMR/view
Current market cap is a joke, only $120M!
I actually bought back into OXGN a few days ago, same price as when I loaded the boat 2003... I have learnt a lot since then and this position will probably be a flipped fairly soon.
Hansa Medical ( HMED.ST ) has a very motivated CEO!
http://hansamedical.com/en/the-importance-of-transplantation
New presentation from Hansa Medical, HMED.ST
http://hansamedical.com/admin/images/userfiles/hmed-companypresentation-9sep2015.pdf
HMED is still by far the most exciting risk/reward stock I have come across during my 15 years as Biotech investor!
Below is a company presentation from September, 2015 that I hope will pique your interest.
As of today HMED has a MC of approximately 840 million SEK which equals to around $100M.
There are 32 412 003 shares outstanding.
They have around $24M in cash
=> Enterprise value of approx. $75M
Hansa Medical (HMED) Interim report January – June 2015
2015-08-25
Operations Summary
Q1
Phase II clinical study of IdeS in highly sensitized patients awaiting kidney
transplantation successfully completed
Cooperation initiated with leading US transplantation expert Dr Stanley Jordan
at Cedars-Sinai Medical Center, Los Angeles
Development of a new generation of IdeS molecules for repeat dosing initiated
Preliminary application for listing on Nasdaq Stockholm submitted
Q2
IdeS Phase II study initiated at Uppsala University Hospital and Karolinska
University Hospital. The first patient treated with IdeS was subsequently
transplanted from a deceased donor
Investigator sponsored Phase II study with IdeS initiated at Cedars-Sinai
Medical Center, US
Hansa Medical established a US medical advisory board
Göran Arvidson new President and CEO of Hansa Medical
Hansa Medical secured MSEK 246 in funding through a fully subscribed rights
issue
Financial Summary Q2 and Year to Date
Net sales for the group in Q2 amounted to MSEK 0.5 (0.3). YTD: MSEK 4.4 (1.5)
Operating result in Q2 was MSEK -22.5 (-4.8). YTD: MSEK -33.2 (-10.7)
Consolidated net result in Q2 was MSEK -22.5 (-4.8). YTD: MSEK -33.2 (-10.8)
Earnings per share before and after dilution in Q2 was SEK -0.70 (-0.18). YTD:
SEK -1.11 (-0.42)
Cash position on June 30, 2015, of MSEK 209.1
Significant events after the reporting period
IdeS Phase I data published in the scientific journal PLOS ONE
First patient treated with IdeS and subsequently transplanted in an investigator
sponsored US Phase II study at Cedars-Sinai Medical Center, Los Angeles
CEO Statement
In the second quarter of 2015, we continued to build on the good start of the
year, when we took some important steps – both financially and in clinical
development – to shape Hansa Medical’s future. Ultimately, we want to create a
strong biopharmaceutical company with life-saving pharmaceuticals on the market.
I feel certain that we are on the right track.
Our lead project IdeS has attracted a lot of attention in the international
scientific community. The results from the earlier clinical Phase I trial of
IdeS were published in the scientific journal PLOS ONE in July. Among other
things, the study results showed that a single dose of IdeS rapidly and
efficiently inactivates IgG in humans, which could make it a very attractive
therapeutic approach for acute IgG driven conditions.
In June, we announced that the first patient after treatment with IdeS in a
clinical Phase II study was successfully transplanted from a deceased donor. The
study will evaluate the safety, tolerability and efficacy of IdeS in kidney
transplantation of sensitized patients. It is also aimed at identifying the
appropriate dose that in the majority of patients will result in anti-HLA
antibody levels acceptable for transplantation within 24 hours from dosing.
In parallel with the ongoing Phase II study in Sweden, other studies are being
initiated, one of which is run by Professor Stanley Jordan, a leading expert in
transplant immunology, at Cedars-Sinai Medical Center in Los Angeles. It is an
open-label study to assess the safety and efficacy of IdeS in eliminating donor
specific antibodies and thus prevent antibody-mediated rejection in sensitized
patients.
This important collaboration with Dr Jordan is a further acknowledgement that
IdeS is an exciting project, quoting Dr Jordan: “IdeS has the potential to
revolutionize the whole area of transplantation, especially in sensitized
patients.” We are also planning for further studies in transplantation and other
IgG mediated indications where there is a significant unmet medical need.
As you will see in this report, we have summarized and in more detail explained
our projects and the various studies we have conducted and are conducting at the
moment. We will continuously update this information on the website.
During the period, we also strengthened our scientific network. In May, we
announced the formation of a US medical advisory board for IdeS in kidney
transplantation. This board is connected with the previously initiated advisory
board of leading transplantation experts in Europe. These advisory boards are
valuable components in establishing IdeS as a potential pharmaceutical product
of great importance.
Early in April, we announced that the MSEK 246 rights issue was fully
subscribed, which means that we now have the means to finance the next exciting
phase, the clinical development of IdeS and our other research projects. We
believe that IdeS has other potential medical indications, including relatively
rare and serious – even life-threatening – acute immune diseases.
We have also continued to strengthen the organisation in and around the company,
in time for the planned change of market place to Nasdaq Stockholm’s main
market. At the annual general meeting on 2 June, Hans Schikan was elected new
board member, adding more first-class biotech experience to the board. The
management was also strengthened with Steven Glazer as CMO and Eva-Maria Joed as
CFO.
On November 13, 2015, we will have the honor to summon interested shareholders
and research partners to a combined investor and research day in Stockholm.
During this event some of the prominent US and European clinical experts we
collaborate with will give us a review from their daily practice and present
their view on the potential of IdeS. We will get back shortly with more details
about this event and how to attend.
The development of Hansa Medical in the first half of this year shows that we
are in an excellent position to build a biopharmaceutical company of lasting
value with important, life-saving products.
Göran Arvidson
President and CEO
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-390 85 30
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused
on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading
enzyme in clinical development, with potential use in transplantation and rare
autoimmune diseases. Other projects include HBP (a market introduced diagnostic
marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in
pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's
share (HMED) is listed on Nasdaq First North in Stockholm with Remium Nordic AB
as Certified Adviser.
- See more at: http://globenewswire.com/news-release/2015/08/25/763074/0/en/Hansa-Medical-Interim-report-January-June-2015.html#sthash.vbefEXSK.dpuf
First patient in IdeS study at Cedars-Sinai Medical Center in Los Angeles receives kidney transplantation
TUE, AUG 11, 2015 08:00 CET
Hansa Medical AB (HMED) today announced that the first patient in an investigator-sponsored Phase II clinical study at Cedars-Sinai Medical Center in Los Angeles, California, has been treated with IdeS and subsequently transplanted.
The study is an open-label study to assess the safety and efficacy of IdeS in eliminating donor specific antibodies and thus prevent antibody-mediated rejection in highly sensitized patients. The study will include up to 20 highly sensitized patients on the UNOS (United Network for Organ Sharing) waiting list.
The principal investigator, Professor Stanley Jordan, is a leading expert in transplant immunology. Hansa Medical has previously announced that Dr. Jordan received a Letter to Proceed from the US food and Drug Administration (FDA) in response to an IND submitted in collaboration with the company.
IdeS will be added to Dr. Jordan’s standard protocols for sensitized patients, and all patients will undergo kidney transplantation. Patients will be followed for 6 months post transplantation.
“We are very pleased that the first patient in the study has been treated. IdeS has the potential to revolutionize the whole area of transplantation, especially in sensitized patients” said Dr. Jordan.
“This collaboration with Dr. Jordan is an important component of the development of IdeS in kidney transplantation. In parallel, we run other clinical studies for IdeS in Europe and plan for further studies in the US”, commented Christian Kjellman, CSO of Hansa Medical.
The information in this press release is disclosed pursuant to the Securities Markets Act or the Financial Instruments Trading Act. The information was released for public disclosure on August 11, 2015, at 08.00 CET.
For further information, please contact:
Hansa Medical AB
Christian Kjellman, Ph.D
Chief Scientific Officer
Mobile: +46 705 717417
E-mail: ?christian.kjellman@hansamedical.com
Göran Arvidson, CEO
Mobile: +46 70-390 85 30
E-mail: goran.arvidson@hansamedical.com
http://www.hansamedical.com/
www.clinicaltrials.gov/ct2/show/NCT02426684?term=IdeS&rank=4
www.nejm.org/doi/full/10.1056/NEJMoa0707894
About IdeS
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. IdeS aims to degrade immunoglobulin G (IgG) and has been tested for safety and efficacy in numerous in vitro and in vivo models. During 2013, a Phase I clinical trial on 29 healthy subjects was conducted, demonstrating IdeS as efficacious and well tolerated with a favourable safety profile. During 2014 and 2015, a Phase II clinical trial in sensitized patients awaiting kidney transplantation has been conducted. Data show that IdeS is effective in reducing anti-HLA antibody levels in highly sensitized patients on the kidney transplant waitlist. The study shows that IdeS has the capacity to make sensitized patients eligible for transplantation by decreasing HLA antibodies to levels acceptable for transplantation. In addition to transplantation, IdeS has potential applications in a variety of rare autoimmune diseases. IdeS is protected by several patents and results of studies with IdeS have been published in a number of peer reviewed medical and scientific journals.
About Dr. Stanley Jordan
Dr. Stanley Jordan is a Director of Kidney Transplantation and Transplant Immunology, Kidney and Pancreas Transplant Center and Director of Division of Pediatric and Adult Nephrology at Cedars Sinai Medical Center, Los Angeles, USA. Dr. Jordan's focus is on immunology and transplantation. He has performed extensive research funded by dozens of research grants and awards, including National Institutes of Health controlled clinical trials in kidney transplantation.
Dr. Jordan has written hundreds of articles in scientific journals and authored about two dozen book chapters. He was appointed by the National Institutes of Health's National Institute of Allergy and Infectious Diseases to advise Congress on the safety and efficacy of intravenous gamma globulin products. Dr. Jordan has been principal investigator on 3 NIH Controlled Clinical Trials in Kidney Transplantation.
He has received the Medical Sciences Award from the UCLA Alumni Association, Gift of Life Award from the National Kidney Foundation, Established Investigator Award from the American Society of Transplantation, Distinguished Alumni Award from the University of North Carolina-Chapel Hill School of Medicine and the inaugural PRISM Award from Cedars-Sinai for excellences in clinical research. Dr. Jordan is a member of national and international professional societies and has served on the editorial boards of numerous professional journals.
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation and rare autoimmune diseases. Other projects include HBP (a market introduced diagnostic marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's share (HMED) is listed on Nasdaq First North in Stockholm with Remium Nordic AB as Certified Adviser.
Transplantation is just the beginning for Hansa Medical (HMED) and their IdeS and/or EndoS
EXTRAPOLATION is the key word!
This patent gives you a good idea of what could be in store..
HANSA MEDICAL, HMED.ST
HMED is by far the most exciting risk/reward stock I have come across during my 15 years as Biotech investor!
Below is a company presentation from March 4, 2015 that I hope will pique your interest.
As of today HMED has a MC of approximately 1 billion SEK which equals to around $120M.
There are 32 412 003 shares outstanding.
They should have around 20-30M in cash (Q2 report not out yet)
All news releases can be found here
Very good news from Hansa Medical (HMED.ST), still only has a MC of $150M!
Successful Phase 2 Study of IdeS in Highly Sensitized Dialysis Patients awaiting Kidney Transplantation
TUE, JAN 20, 2015 13:02 CET
Hansa Medical AB today announced preliminary data showing that IdeS has very good efficacy in a phase 2 study with 8 highly sensitized patients on the waiting-list for kidney transplantation. The study shows that IdeS has the capacity to make sensitized patients eligible for transplantation by decreasing HLA antibodies to acceptable levels. IdeS increased the probability of compatible transplantation by reducing the percentage panel reactivity to low levels in all patients.
Hansa Medical AB today announced preliminary data showing that IdeS has very good efficacy in a phase 2 study with 8 highly sensitized patients on the waiting-list for kidney transplantation. Data analysis shows that IdeS rapidly decreases anti-HLA antibodies to levels acceptable for transplantation, thereby increasing the probability of finding a compatible donor. This is demonstrated by a significant reduction of percentage panel reactivity after treatment. In addition, essentially all IgG was cleaved within 24 hours after dosing in all patients. IdeS was considered safe and well tolerated in HLA sensitized dialysis patients awaiting kidney transplantation.
“IdeS can be directly life-saving for patients waiting for transplantation who have antibodies to transplantation antigens, The worst affected patients represent about 15 % of the wait-listed patients. In addition, a further 25 % of the patients waiting for a transplant may benefit from IdeS treatment." says Gunnar Tufveson, Professor in Transplantation Surgery, Uppsala University Hospital.
“The data show that IdeS swiftly and efficiently degrades the antibodies which prevent kidney transplantation of these patients. We are highly encouraged to pursue further investigation of IdeS for sensitized transplantation patients as well as patients suffering from having other obstructive and pathogenic IgG.” says Christian Kjellman, Chief Scientific Officer of Hansa Medical AB.
About the Study
The phase 2 IdeS study was a single arm, single centre, ascending dose study at Uppsala University Hospital, Sweden. Eight sensitized dialysis patients were included and they received 0.12 or 0.25 mg/kg body weight of intravenous IdeS once or twice within 2 days. IgG was rapidly and efficiently cleaved within minutes after IdeS treatment. Antibodies to HLA, measured with single-antigen bead analysis and T- and B-cell panel reactive antibody analysis, reached levels acceptable for transplantation within hours of treatment. IdeS had an acceptable safety and tolerability profile in the intended category of patients; myalgia and increased susceptibility to infection were identified as potential side effects. Susceptibility to infection is expected in connection with immunosuppressive treatments. Hansa Medical has previously reported about one patient in the study who was made eligible for kidney transplantation by treatment with IdeS and successfully transplanted with a deceased donor. IdeS treatment converted the positive cross-match tests (both FACS-CXM and CDC-CXM) negative, thereby making the transplantation possible. Today, the patient is well, with a fully functional graft without any signs of rejection.
About sensitized patients
Approximately one third of the several hundred thousands of patients waiting for organ transplantation are sensitized to human leukocyte antigen (HLA). These patients have developed antibodies to HLA primarily as the result of allo-immunisation from previous transplantations, blood transfusions or pregnancies. Antibodies to HLA hamper the identification of a suitable donor and HLA-antibodies that react to a potential donor (i.e. a positive cross-match test) are a direct contraindication to transplantation because of the risk of antibody-mediated rejection. Consequently, sensitized patients have extended waiting times on dialysis and risk never being transplanted, despite highest priority. End-stage renal disease patients can be maintained on dialysis However, kidney transplantation is the treatment-of-choice since the patient’s life expectancy and quality of life is dramatically increased and there are substantial cost-savings associated with transplantation compared to dialysis.
About IdeS
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. IdeS degrades all IgG specifically, swiftly and efficiently. IdeS has been tested for safety and efficacy in numerous in vitro and in vivo models. During 2013, a phase I clinical trial on 29 healthy subjects was conducted, demonstrating IdeS as efficacious and well tolerated with a favourable safety profile. During 2014, a phase II clinical trial in sensitized patients awaiting kidney transplantation was initiated, to be reported during 2015. IdeS has potential indications within transplantation and a broad variety of rare autoimmune diseases, where it addresses unmet medical needs. IdeS is protected by several patents and has been published in numerous peer review journals.
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation and rare autoimmune diseases. Other projects include HBP (a market introduced diagnostic marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's share (HMED) is listed on NASDAQ First North in Stockholm with Remium Nordic AB as Certified Adviser. Major shareholders are Farstorps Gård AB and Nexttobe AB.
For further information, please contact:
Hansa Medical AB
Fredrik Lindgren, President and CEO
Mobile: +46 705 61 61 77
E-mail: fredrik.lindgren@hansamedical.com
Emanuel Björne, Corporate Development Director
Mobile: +46 707 17 54 77
E-mail: emanuel.bjorne@hansamedical.com
www.hansamedical.com
Tags:
Transplantation , Orphan Drug , enzyme , kidney , Rare Disease , Hansa Medical AB , IdeS , Sensitized , Desensitization , IgG-degrading enzyme of Streptococcus pyogenes , IgG-degrading
Hansa Medical pursues clinical development and commercialization of innovative pharmaceuticals and diagnostic methods for the benefit of patients with serious and rare inflammatory diseases. The portfolio includes a marketed diagnostic product, a drug candidate in Phase I trial, and a preclinical research project. Major shareholders are Farstorps Gård AB and Nexttobe AB. Hansa Medical is listed on NASDAQ OMX First North (HMED) and Remium Nordic AB is the company’s Certified Adviser.
Contacts
Hansa Medical AB
Scheelevägen 22 22363 Lund, Sweden
+46 46 165670
+46 46 12 77 75
http://www.hansamedical.com
info@hansamedical.com
Webcast Calendar
[Please see updating procedure at
the end of this post. All times are
U.S. ET unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Geron (GERN) Analyst/Investor ASH event
Credit Suisse Healthcare Conference
11/11-14
http://cc.talkpoint.com/cred001/111114a_jw/
UBS European Conference
11/12
http://www.ubs.com/microsites/ib-conferences/emea/european-conference-2014/en/overview.html
AstraZeneca Analyst/Investor Day
11/18
http://www.astrazeneca.com/Investors
Ligand Pharmaceuticals, Inc. Analyst Day
11/18 10AM ET
http://wsw.com/webcast/cc/lgnd/
Stifel Healthcare Conference 2014
11/18-19
http://www.tweisel.com/Stifel/ConferencesAndEvents/Webcasts/
Jefferies Healthcare Conference, London
11/19-20
http://www.jefferies.com/OurFirm/Conferences/325/170
Goldman Sachs US Emerging / SMID Cap Growth Conference
11/20
http://cc.talkpoint.com/gold006/111413a_gm/
Canaccord Genuity Medical Technologies & Diagnostics Forum
11/20
http://www.wsw.com/webcast/canaccord16/
SNY R&D day in Cambridge
11/20
http://en.sanofi.com/investors/events/corporate/2014/2014-11-20_IR_Seminar_NMD.aspx
Tekmira Pharmaceuticals Corporation Analyst Day
11/21 9:00am ET
http://www.media-server.com/m/p/bdwazceb
Piper Jaffray 26th Annual Healthcare Conference
12/2-3
http://www.piperjaffray.com/2col.aspx?id=365
Isis Pharmaceuticals’ Webcast to Discuss ISIS-FXI Rx Data Presented at the ASH Annual Meeting
http://www.videonewswire.com/event.asp?id=101049
12/8 9:00am
Amgen at ASH Conference
http://edge.media-server.com/m/p/6atthgdk/lan/en
12/8 3:00pm (ET)
Agios Pharmaceuticals ASH Webcast
http://edge.media-server.com/m/p/s4b9a35f/lan/en
12/8 3:00pm (ET)
Geron analyst and investor meeting at 7:00 p.m. PT on December 8, 2014
http://edge.media-server.com/m/p/7gbsnwrt or www.geron.com on the Investor Relations pages, under Events
Genmab A/S : to Webcast Post-ASH Investor Seminar
http://cache.merchantcantos.com/webcast/webcaster/4000/7464/16532/43432/Lobby/default.htm
12/9 9:30pm (Not sure on time zone)
EKSO Bionics Technology & Development Day
12/10 7:30am
https://www.webcaster4.com/Webcast/Page/554/6716
Biomarin Analyst and Investor Day in NY
http://www.media-server.com/m/p/zpxuujcj
12/10 8:00am
Shire R&D Day
http://www.shire.com/shireplc/en/investors/calendar?id=163
12/10 8:00am
bluebird bio Post ASH Review Cal
http://edge.media-server.com/m/p/h964jbai/lan/en
12/10 8:00am
Oppenheimer 25th Annual Healthcare Conference
12/10
http://www.opco.com/conferences/healthcare14/index.html
Alnylam Pharmaceuticals R&D Day
http://edge.media-server.com/m/p/njherf95
12/12 8:00am
Onconova Therapeutics Analyst Event
http://investor.onconova.com/events.cfm
12/12 8:30am
Theravance Biopharma Investor and Analyst Day
http://edge.media-server.com/m/p/sgeh9bzj
12/12 9:00am
Dicerna R&D Update
http://www.media-server.com/m/p/2pkz73w5
12/15 4:30pm
Goldman Sachs Healthcare CEOs Unscripted Conference
1/7
Biotech Showcase 2015
1/12-14
33rd JP Morgan Annual Healthcare Conference
1/11-16
Noble Financial Capital Markets D2 - Decade Two - Investor Conference
1/18-21
BIO CEO & Investor Conference
2/9-10
SunTrust Robinson Humphrey Biotechnology and Pharmaceutical One-on-One Orphan Drug Day
2/23
Cowen and Company 35th Annual Health Care Conference
3/2-4
Morgan Stanley European Medtech Conference
3/3
ROTH Capital Partners 27th Annual OC Growth Stock Conference
3/8-11
BioCentury’s Future Leaders in the Biotech Industry Conference
3/20
--
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting new items in alphabetical or chronological order as the case may be.
3. Near the top of the message, give a very brief description of your changes (e.g. “Edits: Added JPMorgan conference”).
4. Post the updated calendar in a new message as a reply to the message with the old calendar.
GERN
Apart from general costs they were supporting the IST and other initiatives, the drug is expensive to make..
Finally I can move on, it's been a longer journey than I had expected but it was worth the wait!
Geron Announces Removal of Full Clinical Hold on Imetelstat IND
Menlo Park, Calif., November 3, 2014 - Geron Corporation (GERN) announced today that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on Geron`s investigational new drug (IND) application for imetelstat. In addition, the FDA stated that Geron`s proposed clinical development plan for imetelstat that is focused on high-risk myeloid malignancies, such as myelofibrosis (MF), is acceptable. The FDA acknowledged that the company does not intend to conduct further studies in, or develop imetelstat for, the treatment of essential thrombocythemia (ET) or polycythemia vera, which is consistent with the company`s plans as originally disclosed in April 2013.
To address the full clinical hold, the FDA required Geron to provide follow-up information from imetelstat-treated patients who experienced liver function test (LFT) abnormalities until such abnormalities resolved to normal or baseline. Geron obtained clinical follow-up information from patients in the previously ongoing company-sponsored Phase 2 trials in ET and multiple myeloma (MM). These data were submitted to the FDA as part of the company`s complete response. The company`s analysis of these data concluded that in the ET trial LFT abnormalities resolved to normal or baseline in 14 of 18 follow-up patients. For the remaining four ET patients, at the time of the data cut-off, three patients showed improvement in LFT abnormalities and one patient had unresolved LFT abnormalities. Currently, two of the remaining four ET patients continue in follow-up. In the MM trial, LFT abnormalities resolved to normal or baseline in all nine follow-up patients. In addition, no emergent hepatic adverse events were reported during follow-up for either study.
The FDA also requested information regarding the reversibility of liver toxicity after chronic imetelstat administration in animals. The company submitted data from its previously conducted non-clinical toxicology studies, which included a six-month study in mice and a nine-month study in cynomolgus monkeys. In these studies, no clinical pathology changes indicative of hepatocellular injury were observed, and no clear signal of LFT abnormalities were identified.
With the lift of the full clinical hold, a multi-center Phase 2 clinical trial in MF is projected to begin in the first half of 2015.
Upcoming Investor Conference
Geron`s management plans to provide an update on the company and development plans for imetelstat at the Stifel Healthcare Conference. The audio and slide presentation will be webcast and is scheduled to occur at 1:50 p.m. Eastern Time on Wednesday, November 19, 2014.
Third Quarter 2014 Financial Results
For the third quarter of 2014, the company reported a net loss of $9.5 million, or $0.06 per share, compared to $8.3 million, or $0.06 per share, for the comparable 2013 period. Revenues for the third quarter of 2014 were $160,000 compared to $181,000 for the comparable 2013 period. The company ended the third quarter of 2014 with $142.5 million in cash and investments.
Total operating expenses for the third quarter of 2014 were $10.1 million compared to $8.9 million for the comparable 2013 period. Research and development expenses for the third quarter of 2014 were $6.0 million compared to $5.3 million for the comparable 2013 period. General and administrative expenses for the third quarter of 2014 were $4.1 million compared to $3.5 million for the comparable 2013 period. Operating expenses for the 2013 third quarter also included restructuring charges of $116,000 in connection with the company`s decisions to discontinue its discovery research programs and close its research laboratory facility in the second quarter of 2013.
The increase in research and development expenses for the third quarter of 2014, compared to the same period in 2013, primarily reflected higher costs for the manufacturing of imetelstat. The increase in general and administrative expenses for the third quarter of 2014, compared to the same period in 2013, was primarily the net result of higher non-cash stock-based compensation expense and increased legal costs associated with the purported securities lawsuits and derivative lawsuit filed against the company, partially offset by reduced patent costs and transaction fees associated with the stem cell divestiture which closed in October 2013.
Interest and other income for the third quarter of 2014 amounted to $91,000 compared to $699,000 for the comparable 2013 period. The decrease in interest and other income for the third quarter of 2014, compared to the same period in 2013, was primarily the net result of a gain on the sale of excess laboratory equipment in connection with the closure of the company`s research laboratory facility in 2013, partially offset by higher interest income due to increased cash and investment balances with the receipt of net cash proceeds from the underwritten public offering the company completed in February 2014.
Nine Months Ended 2014 Financial Results
Net loss for the first nine months of 2014 was $26.7 million, or $0.18 per share, compared to $29.1 million, or $0.23 per share, for the comparable 2013 period. Revenues for the first nine months of 2014 were $1.0 million compared to $1.1 million for the comparable 2013 period.
Total operating expenses for the first nine months of 2014 were $28.3 million compared to $30.7 million for the comparable 2013 period. Research and development expenses for the first nine months of 2014 were $16.4 million compared to $18.1 million for the comparable 2013 period. General and administrative expenses for the first nine months of 2014 were $11.9 million compared to $11.6 million for the comparable 2013 period. Year-to-date operating expenses for 2013 also included restructuring charges of $1.0 million.
The decrease in research and development expenses for the first nine months of 2014, compared to the same period in 2013, was primarily the net result of lower clinical trial expenses with the wind-down of the imetelstat trials in solid tumors and GRN1005 trials in patients with brain metastases and reduced personnel-related and other research costs resulting from previous restructurings and the discontinuation of the company`s discovery research programs, partially offset by higher costs for the manufacturing of imetelstat. The increase in general and administrative expenses for first nine months of 2014, compared to the same period in 2013, was primarily the net result of higher non-cash stock-based compensation expense and increased legal costs associated with the purported lawsuits, partially offset by reduced patent costs and transaction fees associated with the stem cell divestiture.
Interest and other income for the first nine months of 2014 was $273,000 compared to $836,000 for the comparable 2013 period. The decrease in interest and other income for the first nine months of 2014, compared to the same period in 2013, was primarily the net result of a gain in 2013 for the sale of excess laboratory equipment, partially offset by an increase in interest income in 2014.
About Geron
Geron is a clinical stage biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
GERN
I'm clearly aware of that, this comment is for those myopic people that has dug in on the idea that the clinical hold on GERNs ET study has any real impact on the future success of the company.
As is apparent from the current share price, a lot of people are misinformed but they will soon understand..
GERN
Geron has updated their information on their clinical trials and from their perspective there is no clinical hold on their phase II MF trial!
I believe my recent GERN trade will be even more lucrative than the one I had with ACAD...
Huge news for HMED.ST, still not appreciated in Sweden, MC only around $80M
HANSA MEDICAL: THE HANSA MEDICAL CANDIDATE DRUG IDES HAS ENABLED SUCCESSFUL KIDNEY TRANSPLANTATION
2014-08-18
A successful kidney transplantation of an HLA sensitized patient has
been accomplished following desensitization with the candidate drug
IdeS at Uppsala University Hospital. The patient is enrolled in the
ongoing Phase II study sponsored by Hansa Medical with the primary
objective to study IdeS capacity to reduce levels of anti-HLA
antibodies in sensitized patients.
HLA sensitized patients rarely become transplanted due to the
immediate risk of transplant rejection caused by donor specific
anti-HLA antibodies. However, following treatment with IdeS the now
transplanted patient became eligible for deceased donor
transplantation after treatment with IdeS. The cross match test,
determining if the patient was compatible with the deceased donor,
showed that the donor specific antibodies had been completely
inactivated by the IdeS-treatment making the cross match negative.
The patient was then successfully transplanted and the transplanted
kidney is now perfectly functional.
We have demonstrated, for the first time, that IdeS can enable
transplantation for patients burdened by anti-HLA antibodies as the
primary obstacle to transplantation. I am very happy that we by
treatment with IdeS, have managed to help this patient to become
transplanted, comments Emanuel Björne, CEO Hansa Medical AB (publ).
Thousands of sensitized patients around the world live in a hopeless
wait, hindered from transplantation due to high levels of anti-HLA
antibodies. These patients face long-term dialysis, associated with
significantly shortened life expectancy and reduced quality of life.
The goal of Hansa Medical is that all these patients shall be
transplanted through treatment with IdeS.
We have purposefully brought our unique IdeS-concept from discovery,
through phases of research and development into effective and safe
treatment of a patient. This brings hope to patients in need and is a
major success for my dedicated colleagues here at Hansa Medical and
at Uppsala University Hospital as well as for our long term committed
owners whose investments made this possible, concludes Emanuel
Björne, CEO Hansa Medical AB (publ).
More on IdeS
The candidate drug IdeS is developed as a fast, effective and safe
method to deactivate anti-HLA antibodies in sensitized patients prior
to kidney transplantation. During 2013, a successful Phase I-study on
29 healthy subjects was performed, demonstrating IdeS as efficacious
and well tolerated with a favourable safety profile. The purpose of
the ongoing Phase II-study is to explore IdeS safety and efficacy on
anti-HLA antibodies in sensitized patients awaiting kidney
transplantation. The objective is to generate significant clinical
data in order to enable a pivotal phase III trial. In total,
approximately 20 patients will be enrolled in two separate phase II
studies planned to last until the second quarter of 2015.
Geron to Assume Sponsorship of Myelofibrosis IST and IND
Menlo Park, Calif., August 5, 2014 - Geron Corporation (GERN) announced today that the company has entered into a transfer agreement with Mayo Clinic whereby the Investigational New Drug (IND) application for imetelstat under which the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST) has been conducted will be transferred from Mayo Clinic to Geron. In addition, Geron will assume sponsorship for the Myelofibrosis IST, and Dr. Ayalew Tefferi will remain the principal investigator for the study. The company and Mayo Clinic have agreed that the IND and sponsorship responsibility for the conduct of the Myelofibrosis IST will be transferred to Geron by September 30, 2014. In light of the full clinical hold placed on the company`s IND, Geron has committed to the U.S. Food and Drug Administration (FDA) that the company will not initiate any new clinical studies under the transferred IND from Mayo Clinic until Geron has had further communication with the FDA regarding the company`s IND and development plans for imetelstat.
The Myelofibrosis IST ceased enrolling patients in January 2014. Under Geron`s sponsorship, the patients remaining in the study - which include patients with myelofibrosis (MF), blast phase MF, and refractory anemia with ringed sideroblasts, a subtype of the myelodysplastic syndromes (RARS-MDS) - will continue to receive treatment with imetelstat or continue in follow-up. Geron does not intend to enroll additional patients in this study. The company plans to use the transferred data and information from the Myelofibrosis IST to inform the design of Geron`s planned Phase 2 clinical trial in MF.
These developments will be discussed during Geron`s second quarter conference call to be held on Monday, August 11, 2014, at 4:30 p.m. Eastern Time. Information for participating in the conference call is available on the company`s website at www.geron.com.
HMED.ST
HANSA MEDICAL: HANSA MEDICAL TO PRESENT IdeS AT THE 2014 WORLD TRANSPLANT CONGRESS IN SAN FRANCISCO, JULY 27
Hansa Medical will present the drug candidate IdeSs potential as a
novel treatment for desensitization prior to kidney transplantation,
at the poster session on July 27 at the 2014 World Transplant
Congress in San Francisco, USA.
The World Transplant Congress gathers international experts on
transplantation, attracts prominent keynote speakers as well as
pharmaceutical and biotechnology companies committed to the
improvement of treatment of transplantation patients.
For more information about the World Transplant Congress, please
visit: www.wtc2014.org
The poster presentation will emphasize IdeS antibody deactivating
effect and safety, demonstrated in a recently concluded Phase I study
in healthy volunteers as well as in sera from sensitized patients
pre-kidney transplantation.
More on IdeS
Hansa Medicals drug candidate IdeS is developed as a fast, safe and
expedient method to deactivate IgG-antibodies in sensitized patients
prior to kidney transplantation. For sensitized patients,
IgG-antibodies pose the primary obstacle for a transplant, forcing
patients into years of treatment in dialysis. A successful Phase
I-study was finalized in January 2014 and a Phase II study is planned
for 2014 in sensitized patients awaiting kidney transplantation.
For further information, please contact:
Hansa Medical AB
Emanuel Björne, CEO Hansa Medical AB (publ)
Mobile: 46 707 17 54 77
E-mail: emanuel.bjorne@hansamedical.com
www.hansamedical.com
GERN
Wow, that was sooner than even I had hoped!!
Geron Reports Removal of Partial Clinical Hold on Myelofibrosis IST
Menlo Park, Calif., June 12, 2014 - Geron Corporation (GERN) announced today that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST). The partial clinical hold was placed in March 2014 due to a safety signal of hepatotoxicity that was identified in clinical trials of imetelstat. In order to resolve the partial clinical hold, the investigator, Dr. Ayalew Tefferi of Mayo Clinic, Rochester, Minnesota, was required to provide follow-up information regarding reversibility of hepatotoxicity for all patients who received imetelstat in the Myelofibrosis IST. In its letter dated June 11, 2014, the FDA informed the investigator that it had completed the review of his complete response submission and concluded that the Myelofibrosis IST may proceed.
As previously announced, the Myelofibrosis IST ceased enrolling new patients in January 2014, and Mayo Clinic did not cite any safety concerns as the basis for that decision. Previously enrolled patients who are deriving clinical benefit continue to receive treatment with imetelstat.
Geron`s Investigational New Drug (IND) application for imetelstat remains on full clinical hold affecting the company`s clinical trials in essential thrombocythemia or polycythemia vera and in multiple myeloma. Until the FDA lifts the full clinical hold on Geron`s IND, the company is unable to submit any new clinical trial protocols to the FDA under the company`s IND for imetelstat and is unable to initiate any new clinical trials for imetelstat in the United States. The company is working diligently to seek release of the full clinical hold.
About Geron
Geron is a clinical stage biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
GERN
That slide is about what Geron has to do to satisfy FDA concerning the full clinical hold on the Geron sponsored studies in ET/PV.
The partial clinical hold on the MF study at Mayo could be lifted much sooner.
That said, the recent rise in share price is most probably related to technical factors and ignited by an article in The Street, not that I complain..
HMED.ST
A recent video interview with the CEO of Hansa Medical, it appears they are planning to start trials in autoimmune diseases this year!
Geron (GERN) Director Daniel Bradbury acquires 142,776 Shares.
HMED.ST
Swedish Medical Products Agency approves Hansa Medical’s clinical Phase II-study application with IdeS
TUE, MAY 06, 2014 08:00 CET
Hansa Medical announces the Swedish Medical Products Agency’s approval of the application to carry out a clinical Phase II-study with the drug candidate IdeS. The study’s primary objective is to investigate IdeS’ efficacy and safety in sensitised kidney transplantation patients. The Phase II-study will be conducted at Uppsala University Hospital and is scheduled to begin in the second quarter of 2014.
The drug candidate IdeS is developed for fast and efficient inactivation of circulating IgG-antibodies in sensitised patients awaiting kidney transplants. The ambition is to enable transplantation for thousands of patients with kidney disease a few minutes after distributing an intravenous injection with IdeS. In 2013, a Phase I-study on 29 healthy subjects, demonstrated that IdeS is efficacious and is well tolerated with a favourable safety profile.
The approved Phase II-study will explore IdeS’ safety and efficacy on anti-HLA antibodies in sensitised patients waiting for kidney transplants. In the second quarter of 2014, Hansa Medical will file an application for a second Phase II-study with the Swedish Medical Products Agency. The second Phase II-study will establish IdeS’ efficacy and safety in conjunction with kidney transplantation in sensitised patients. IdeS’ combined Phase II-trials will include approximately 15 patients, last for approximately 12 months and begin in the second quarter of 2014.
Sensitised patients
Defining the patient group are individuals immunized to HLA (Human Leukocyte Antigen), a ubiquitous protein on all cell surfaces. Anti-HLA antibodies constitutes an immediate barrier for transplantation of sensitised patients due to the apparent risk of transplant rejection. Sensitised patients in need of transplantation are therefor referred to long-term dialysis, associated with increased risk of infection, cardiovascular disease and a significantly shortened life expectancy.
For further information, please contact:
Hansa Medical AB
Emanuel Björne, CEO Hansa Medical AB (publ)
Mobile: 46 707 17 54 77
E-mail: emanuel.bjorne@hansamedical.com
www.hansamedical.com
Hansa Medical pursues clinical development and commercialization of innovative pharmaceuticals and diagnostic methods for the benefit of patients with serious and rare inflammatory diseases. The portfolio includes a marketed diagnostic product, a drug candidate in clinical development, and a preclinical research project. Major shareholders are Bo Håkansson via Farstorps Gård AB, and Nexttobe AB. Hansa Medical is listed on NASDAQ OMX First North (HMED) and Remium Nordic AB is the company’s Certified Adviser. The information in this press release is such information that Hansa Medical AB (publ) is obliged to disclose under the Securities Market Act and/or the Financial Instruments Trading Act. The information was made public on May 6, 2014 at 08:00 CET.
Transplantation , Orphan Drug , enzyme , kidney , Rare Disease , Hansa Medical AB , IdeS , Sensitized , Desensitization , IgG-degrading enzyme of Streptococcus pyogenes , IgG-degrading , donor specific antibodies , DSA
About Us
Hansa Medical pursues clinical development and commercialization of innovative pharmaceuticals and diagnostic methods for the benefit of patients with serious and rare inflammatory diseases. The portfolio includes a marketed diagnostic product, a drug candidate in Phase I trial, and a preclinical research project. Major shareholders are Bo Håkansson via Farstorps Gård AB, and Bengt Ågerup via Nexttobe AB. Hansa Medical is listed on NASDAQ OMX First North (HMED) and Remium Nordic AB is the company’s Certified Adviser.
Contacts
Hansa Medical AB
Scheelevägen 22 22363 Lund, Sweden
+46 46 165670
+46 46 12 77 75
http://www.hansamedical.com
info@hansamedical.com
HMED.ST
Started a large position in a very promising company, Hansa Medical from my backyard.
I particularly like this company because of their unique pipeline, bacterially derived enzymes for transplantation and acute autoimmune disorders.
If you want something other than the usual stuff, take a look!
Currently, $HMED.ST has 26M shares outstanding with a MC of $56M.
Many catalysts within a year or so could substantially increase value. Also note that this company is listed on a small Swedish exchange and is REALLY under the radar!!
I would add pimavanserin from ACAD as a potential competitive compound.
True, it took an awful long time, I'm glad that I got back in just in time..
OXGN
A new presentation of OXIGENE is available.
OXGN
Encouraging results from OXiGENE's closest competitor, Bionomics, down under..
3 February 2014
BNC105 PHASE I/II TRIAL ACHIEVES A HIGH RESPONSE RATE IN
OVARIAN CANCER
* 10 out of 15 patients with positive response in Phase I
* Recommended Phase II dose level of 12 mg/m2 determined
* Results support continued development in the ovarian cancer setting
Bionomics Limited (ASX:BNO, ADR:BMICY) has received positive results in the Phase I clinical trial
of its cancer drug candidate BNC105 in women with ovarian cancer.
After completing the enrolment of 15 patients for the Phase I portion of the trial during 2013, data to
date has found 10 of the patients have achieved a positive response according to the RECIST 1.1
and/or GCIG CA125 criteria.
The patients were treated with BNC105 in combination with the current standard therapy of
carboplatin and gemcitabine. In line with the primary endpoint of the trial, 12mg/m2
was identified as the recommended BNC105 dose to take into Phase II in this combination.
Biomarker analyses of blood samples from patients taken within four hours of administration of
BNC105 demonstrated that the 12mg/m2 dose induced a pharmacodynamic response indicative of
BNC105 activity. The same biomarkers have been observed in association with BNC105 activity in
previous clinical trials.
One patient has completed the protocol-prescribed 12 cycles of treatment comprised of six cycles of
combination therapy and six cycles of BNC105 monotherapy. This patient has experienced clinical
benefit and has continued on BNC105 monotherapy since.
12 of the 15 patients completed six cycles of combination therapy and commenced with BNC105
monotherapy. Thus far the mean number of treatment cycles across the study is 8.8, with each cycle
of treatment representing three weeks. Three patients are currently continuing with treatment.
“This is very positive reinforcement of what we have come to expect for BNC105,” said CEO and
Managing Director of Bionomics Dr Deborah Rathjen.
“Ovarian cancer is the fifth leading cause of cancer-related deaths in women and we are extremely
grateful to the patients who participated in this study.”
“The market for drugs to treat ovarian cancer is valued at over $2 billion per annum and there remains
significant unmet need for effective treatments. With these results we anticipate that we will be able
advance our partnering strategy for BNC105.”
The trials are being conducted across six sites by the Australian and New Zealand Gynaecological
Oncology Group (ANZGOG), the National Health and Medical Research Council Clinical Trials Centre
(NH&MRC CTC) and the Hoosier Oncology Group in the United States.
“Some adverse effects were witnessed in patients but these were of haematological origin consistent
with the backbone of the carboplatin and gemcitabine drug combination,” said Dr José Iglesias, Chief
Medical Officer of Bionomics.
Principal Investigator for the trial Dr Danny Rischin commented “The results support continued
development of BNC105 in the ovarian cancer setting to further investigate the potential of BNC105
as a new drug that may have a clinically significant impact.”
The American Cancer Society estimated that in 2013 approximately 22,240 new cases of ovarian
cancer were diagnosed in the US and about 14,000 women would die of the disease.
Ovarian cancer is often diagnosed at an advanced stage after the cancer has spread beyond the
ovary. Despite some improvements in patient outcomes the majority of patients relapse after surgery
and chemotherapy and die of their disease. This clear unmet medical need is something Bionomics is
endeavouring to address with BNC105.
GERN
What do you mean by truncating enrollment, do you have access to other numbers apart from this?
XOMA
There are 3 IL-1 inhibitors on the market associated with the ligand/receptor signaling interaction, anakinra (Kineret; Amgen/Biovitrum), canakinumab (Ilaris; Novartis) and rilonacept (Arcalyst; Regeneron).
Anakinra and rilonacept inhibits the effect of IL-1alpha as well as those of beta.
As I understand it, diacerein/rhein prevents, the formation of IL-1beta and not the receptors.
CNDO
Coronado Biosciences Announces Presentation of Interim Data From Autism Study at Neuropsychopharmacology Meeting
Study Investigator Eric Hollander, M.D., Reports Potential Benefits of TSO Immunotherapy in First 5 Patients
Study Completion and Final Results Expected Mid-2014
BURLINGTON, Mass., Dec. 12, 2013 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc. (CNDO), a biopharmaceutical company developing novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine of Yeshiva University and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and Einstein, presented interim data from his pilot study of oral TSO (Trichuris suis ova or CNDO-201) to treat autism at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.
The study is a double-blind, randomized, placebo-controlled, cross-over study and enrolled 10 high-functioning adult autism spectrum disorder patients who were able to give informed consent to participate in the study and who had a history of allergies and/or a family history of immune-inflammatory illness. They were treated for 12 weeks with either TSO or placebo, followed by a 4-week washout phase and then 12 weeks of placebo or TSO. The TSO dosage used in the study was 2,500 ova once every two weeks.
In the first 5 patients that completed the study, there was a statistically significant separation from placebo in favor of TSO on three measures of disease: the Montefiore-Einstein Rigidity Scale (MERS), the Repetitive Behavior Scale-Revised (RBS-R) Sameness Scale, and the Social Responsiveness Scale (SRS)-Repetitive Behaviors Scale. The treatment was well tolerated.
The study is still ongoing and final results are expected in the middle of 2014.
"There is increasing evidence that immune dysregulation plays an important role in this developmental disorder and we are encouraged by the interim data from this pilot study with TSO," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "We believe autism is an area of unmet medical need where a natural immune system regulator like TSO may help a part of the autism population."
Do you know anything about this or are you just trying to be funny..?
Remember ACAD, their pimavanserin had some trouble beating placebo, the company took a deep breath and came back with a vengeance.. CNDO will do the same thing and I'm absolutely certain they eventually will show that TSO can alter the immune system and meaningfully dampen autoimmunity!