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NICE Technology appraisal guidance info updated to new status "Topic selection":
Status Topic selection
Technology type Medicine
Decision Awaiting decision
ID number 836
( https://www.nice.org.uk/guidance/topic-selection/gid-ta10143 )
Previous status before discontinuation yesterday was:
Status Suspended
Decision Selected
Process STA pre-2018
ID number 836
( https://web.archive.org/web/20220520164302/https://www.nice.org.uk/guidance/indevelopment/gid-ta10143 )
The volume over the whole day is usually lower:
27.04.21. 1.240,00 EUR
26.04.21. 5.296,90 EUR
23.04.21. 388,17 EUR
22.04.21. 9.147,00 EUR
20.04.21. 1.157,57 EUR
19.04.21. 1.100,00 EUR
16.04.21. 1.155,00 EUR
15.04.21. 3.820,00 EUR
today after 2 hours:
28.04.21. 33.027,11 EUR
Well, at least one buyer wants to get some shares right now.
Servus Dr. C S,
any updates available?
Cognate BioServices plans $212M investment in Memphis ops
Memphis Business Journal
By Greg Akers
Editor-in-Chief, Memphis Business Journal
Nov 13, 2020, 3:04pm CST
Updated 26 minutes ago
A bioscience company with a large local presence is planning a new investment that would create hundreds of jobs and see three industrial sites receive major renovations and new construction.
Cognate BioServices Inc. plans to renovate three properties for "cell-therapy operations, contract development, and manufacturing for drug sponsors, and related logistics."
The company is seeking a 15-year Jobs PILOT (payment-in-lieu-of-taxes) from the Economic Development Growth Engine (EDGE) for Memphis and Shelby County. The incentive would be worth $52 million, and be based on a $212 million project investment.
The investment would include $126 million in construction costs and $71 million in personal property. It covers sites at 4600 E. Shelby Drive, 5780 E. Shelby Drive, and 6100 Global Drive.
According to the EDGE summary, the project will create 561 jobs, with an average annual wage of $63,749. The expansion would see the construction of new cell-therapy "clean room" suites, and warehousing, which would make for a significant increase in its manufacturing capacity.
Cognate is a contract developer and manufacturer of advanced cell and gene therapies. About a year ago, it got a capital infusion to acquire a UK biosciences firm. That deal helped position the company to be directly involved in the development of two COVID-19 vaccine candidates.
Cognate's EDGE application says the company also recently "manufactured the product for the world's largest clinical trial for a treatment for glioblastoma multiforme, considered the most aggressive form of brain cancer."
Its clients include AstraZeneca, Atara Biotherapeutics Inc. and Northwest Biotherapeutics Inc.
Companywide, it has 568 employees, with 287 located at its current location at 4600 E. Shelby, which it established in 2007.
The PILOT made Memphis a more attractive site for this project versus Baltimore and Dallas, the application said.
Cognate is planning for a possible second phase of the project, with a further expansion and investment, but this PILOT would only cover phase one. But, the application said, "The two phases are integrally linked." Phase two could be proposed by Dec. 1, 2024, and see the development of another three sites, at 6099 Global Drive along with parcels on Distriplex Farms and Crumpler Road. All told, phase two could be comprised of a capital investment between $147 million and $300 million and the creation of another 250 to 550 jobs, with average wages of $50,000 to $65,000.
Phase one details:
4600 E. Shelby Drive: $30 million in construction of new clean room suites and manufacturing support areas. A quarter of the facility's existing 88,000 square feet would be renovated for the new uses. By 2024, 230 net new jobs would be located here. The owner of the building is Thomson Logistics Assets LLC.
5780 E. Shelby Drive: Cognate would relocate the warehousing it does at 4600 E. Shelby to this new location. It would occupy 50,000 square feet of space, including new office buildout, for a total improvement cost of $2 million. It would net 10 new jobs by 2024. The owner of the property is A.L. Dougherty - Tennessee LLC.
6100 Global Drive: This new location for Cognate would contain new clean room suites and more manufacturing support areas, which would entail $94 million in improvement costs. The company would take over 123,000 square feet of existing improvements there, and would also benefit from new construction improvements. At this location, 321 net new jobs would be created by 2024. The owner is Exeter 6100 Global LLC.
Cognate is being represented by the Memphis law firm Martin, Tate, Morrow & Marston. The application will go before the EDGE board on Wednesday, Nov. 18.
Companies In This Article
Cognate BioServices Inc.
Memphis, TN
Biotechnology
520 Employees
See full profile
That's because if their vanitas
That's right: The status is 'Temporarily halted'
Best regards
KaOsiris
endpoints are the same but trial status is not:
Trial Status: Temporarily Halted
Revised endpoints now also updated by PEI on german part of the EU Clinical Trials Register:
clinicaltrialsregister.eu
Since NWBO is on the OTC, it's almost impossible to buy NWBO shares in Stuttgart for an € amount corresponding to the then current US$ amount.
For most german retail, Suttgart is the only place to buy NWBO as their brokers don't offer buying/selling at the OTC anymore.
As there is almost no market activity in Stuttgart, it is more or less only the Spezialist (MM) of Stugart who sells shares. And he usually does only fulfil a buy order if it is ahout 10-15% over the current US quote.
Hi beartrap, Hi Sojourner55,
I'm using usually https://wertpapiere.ing.de/Investieren/Aktie/Boersen/US66737P6007
And yes, it's thinly traded in Stuttgart (1€=1,0895$):
25.05.20 2.667,60 EUR
22.05.20 14.030,40 EUR
21.05.20 -
20.05.20 2.200,80 EUR
19.05.20 208,00 EUR
18.05.20 2.940,00 EUR
15.05.20 -
14.05.20 -
13.05.20 430,00 EUR
12.05.20 -
11.05.20 -
08.05.20 -
07.05.20 -
06.05.20 -
05.05.20 -
04.05.20 -
30.04.20 1.710,00 EUR
29.04.20 -
28.04.20 -
27.04.20 -
Best regards
KaOsiris
thanks,
no I'm in Germany and my current brokers don't trafe OTC any more.
I also have an account at Interactive Brokers via Lynx and so I could trade NWBO in the US at the OTC. But as I prefer for the time beeing to keep my about 350k shares at a broker where I can access them easily, I wont transfer funds to IB
Gruß KaOsiris
On August 28, 2019, DelMar Pharmaceuticals, Inc. (the “Company”) used the slides attached hereto as Exhibit 99.1 in connection with management presentations to describe its business. (8k)
presentation slides
NWBO @ Boerse Stuttgart:
https://www.boerse-stuttgart.de/de-de/produkte/aktien/stuttgart/a1j5ey-nort
There is very very little volume and most of the time the quote is just the bid, which is at least 10% below the current US quote.
Hi Rkmatters,
are you still following Delmar?
It seems to me, the prospects of DMPI are not this bad now that the RS has been done, the financing at 3,?? went through and they published quite good results for rGBM.
I used some liquidity that I gained from selling NWBO after ASCO in Germany before open in US to get some DMPI, although I plan to get at least all the shares of NWBO I sold back (at lower price, i.e below 0,27$) as I still think (gamble on?) NWBO will be my "jackpot".
Unfortunately, the DMPI board here at investorshub is completely bullshit - I hope, some real knowledgeable people like you come in and disciss - as in the NWBO board - the science and prospects.
Best regards
5-ALA guided surgery:
As I read several posts where people asked themselfs, whether "the dye" used could possibly alter the tumor tissue used for the lysate, I will share my thoughts on this.
Caveat: Although I made my PhD in exactly the lab (Laserforschungslabor der Urologischen Klinik, Klinikum Großhadern, München, Germany) that developped the technology Walter Stummer - who was cited by one poster on the board as (one of) the first to publish on 5-ALA guided neurosurgery - used, the following may be not completely scientifically correct as I worked on different things and my time in this lab was about 20 years ago.
The beauty and advantage of this 5-AlA based fluorescence diagnostics or surgery is that it only deals with endogeneous substances. The body produces 5- ALA himself in the course of the porphyrine biosynthesis of heme.
Once 5-ALA is applied topically or systemically (i.e. in much higher quantities than the body would produces), a following product, protoporphyrine IX (PPIX) is found generally in much higher quantities in altered (inlammed, precancerous, cancerous) tissue than in normal tissue. This might be due to an reduced activity of the ferrochelatase that inserts iron into the porphyrine ring of PPIX, thereby producing heme.
And PPIX is a fluorophore and can be excited with UV light around 405nm, so that you can see a red flourescing area where PPIX has been enriched in the tissue.
By cleverly designing the characteristics of the optical Filters used that block most but not all of the excitation light, it is possible to see the tissue in a great blue (normal) - red (altered) contrast.
For those intersted to dig deeper into this, I propose to search for publications with authors Herbert Stepp or Reinhold Baumgartner or also Hubert VandenBerg(h?), the leader of another important group in this field from EPFL in Lausanne, Switzerland.
So, as its based on endogeneous substances, in my opinion there should he no interference of this 5-ALA guided resection with the production of the lysate and DCVAX-L
Best regards
I might be wromg, but I personllay have the feeling that in fact there is NO personal compass, no ethics, no acting as s ocial beeing, as the only motivation seems to be self-enrichrmemt
Asterias Announces Additional Motor Function Improvement at 6-months and 9-months Following Treatment with AST-OPC1 in Patients with Complete Cervical Spinal Cord Injuries
-Management to discuss results on conference call today at 5:00 p.m. Eastern / 2:00 p.m. Pacific-
-SCiStar lead investigator Richard Fessler, MD, and John Steeves, Ph.D., Co-Chair of the Spinal Cord Outcomes Partnership Endeavor (SCOPE), will join Asterias management on the call-
News provided by
Asterias Biotherapeutics, Inc.
Jan 24, 2017, 07:00 ET
Share this article
FREMONT, Calif., Jan. 24, 2017 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced positive efficacy results from the company's ongoing SCiStar Phase 1/2a clinical trial that showed additional motor function improvement at 6-months and 9-months following administration of 10 million AST-OPC1 cells in AIS-A patients with complete cervical spinal cord injuries (SCI).
"Recovery of upper extremity motor function is critically important to patients with complete cervical spinal cord injuries, since this can dramatically improve quality of life and their ability to live independently," said Richard Fessler, M.D., Professor, Department of Neurosurgery at Rush University Medical Center and lead investigator in the SCiStar study. "Patients in this cohort are seeing what we believe are meaningful improvements in their ability to use their arms, hands and fingers at 6-months and 9-months following AST-OPC1 administration."
"The results to date in the 10 million cell cohort treated with AST-OPC1 cells show that the improvements in arm, hand and finger function observed very early in the study have been maintained and in most patients have even been further enhanced over time," said Steve Cartt, Chief Executive Officer of Asterias. "These results to date are quite encouraging, and we look forward to initiating discussions with the FDA in mid-2017 to begin to determine the most appropriate clinical and regulatory path forward for this innovative therapy. In addition, we anticipate reporting 12-month efficacy and safety data for this cohort, as well as 6-month efficacy and safety data for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts, during the third quarter of 2017."
A total of six patients were enrolled and dosed in the AIS-A 10 million-cell cohort, with five of six patients having now completed their 6-month follow-up and three of six patients having completed their 9-month follow-up.
Improvements in upper extremity motor function are being measured using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, widely used to quantify functional status of patients with spinal cord injuries. The latest results include the following highlights:
Improvements in Motor Function
Upper Extremity Motor Score - For the five patients who have completed at least 6 months of follow-up, five of five patients saw their early improvements in motor score (UEMS) at 3 months maintained or further increased through their most recent data point (6 months or 9 months, depending on the most recent data available for each patient).
Motor Level Improvement - For patients completing at least 6 months of follow up, as of the date of each patient's last follow-up visit, 100% (five of five) had achieved at least a one motor level improvement (using the ISNCSCI scale) over baseline on at least one side, and 40% (two of five) had achieved two motor levels over baseline on at least one side, with one of these patients achieving a two motor level improvement on both sides.
Matched Historical Control Data - Asterias and key experts in the spinal cord injury field have developed a set of matched historical control data for both Upper Extremity Motor Score and Motor Level Improvement to clearly document expected spontaneous recovery in untreated patients for comparison to results seen in patients treated with AST-OPC1. The key results from this analysis, which show a meaningful difference in the motor function recovery seen to date in patients treated with the 10 million cell dose of AST-OPC1, will be presented during today's conference call.
Safety
The trial results to date continue to reveal a positive safety profile for AST-OPC1. There have been no serious adverse events related to AST-OPC1 and data from the study indicate that AST-OPC1 can be safely administered to patients in the subacute period after severe cervical spinal cord injury.
In September 2016, Asterias reported positive early efficacy data for AST-OPC1 from the AIS-A patients that had been dosed with 10 million AST-OPC1 cells in the SCiStar study. Today's data show that the improvements in motor function seen at 3 months post-implantation of AST-OPC1 for these patients appear to be maintained, and in some cases improved even further, on continued follow up. Furthermore, these results suggest that the observed gains exceed the expected rates of spontaneous recovery in a closely matched population of historical controls.
Each year in the U.S. more than 17,000 people suffer a severe, debilitating spinal cord injury. These injuries can be devastating to quality of life and ability to function independently. Lifetime healthcare costs for these patients can often approach $5 million. Improvements in arm, hand and finger functional capabilities in these patients can result in lower healthcare costs, significant improvements in quality of life, increased ability to engage in activities of daily living, and increased independence.
Conference Call and Webcast Today at 5:00 p.m. ET (2:00 p.m. PT) to Discuss the Results
Asterias will host a conference call and webcast today, January 24, 2017 at 5:00 p.m. Eastern / 2:00 p.m. Pacific to discuss the results. Company management will be joined by Richard G. Fessler, MD, PhD, Professor, Department of Neurosurgery at Rush University Medical Center and SCiStar lead investigator, and John Steeves, Ph.D., Co-Chair of the Spinal Cord Outcomes Partnership Endeavor (SCOPE) and Professor of International Collaboration on Repair Discoveries (ICORD).
BIND Therapeutics Announces Two Bidders Join Pfizer’s Stalking Horse Bid in Auction for BIND’s Assets
businesswire.com
July 25, 2016 07:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--BIND Therapeutics, Inc. (NASDAQ:BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS®, today announced that it has received two bids that are qualified to participate in the Court authorized auction beginning at 10 a.m. EST on July 25, 2016. The bids are in addition to Pfizer Inc.’s initial stalking horse bid of approximately $20 million under Section 363 of the U.S. Bankruptcy Code.
The U.S. Bankruptcy Court has authorized BIND to proceed with an auction on July 25, 2016 and the Company intends to select the highest and best offer at the conclusion of the auction. The winning bid is subject to U.S. Bankruptcy Court approval and a hearing is scheduled to take place on July 27, 2016.
BIND initiated voluntary Chapter 11 bankruptcy protection on May 1, 2016 and is conducting a sale of assets pursuant to Section 363 of the Bankruptcy Code.
Broadening response rates to PD-1 therapy in advanced lung adenocarcinoma: Viagenpumatucel-l (HS-110) in combination with nivolumab in the ongoing DURGA trial.
ASCO Abstract
Sub-category:
Metastatic Non-Small Cell Lung Cancer
Category:
Lung Cancer—Non-Small Cell Metastatic
Meeting:
2016 ASCO Annual Meeting
Abstract No:
TPS9102
Poster Board Number:
Poster Session (Board #423b)
Citation:
J Clin Oncol 34, 2016 (suppl; abstr TPS9102)
Author(s): Daniel Morgensztern, Wael A. Harb, Kurt Alex Schalper, Melissa Leigh Price, Brandon Early, Taylor Houghton Schreiber; Washington University School of Medicine in St. Louis, St. Louis, MO; Horizon Oncology Center, Lafayette, IN; Yale University, New Haven, CT; Heat Biologics, Durham, NC; Heat Biologics Inc, Durham, NC
Abstract Disclosures
Abstract:
Background: Viagenpumatucel-L (HS-110) is an allogeneic whole-cell vaccine, selected for high expression of adenocarcinoma tumor antigens, transfected to secrete gp96-Ig. Cell-secreted gp96-Ig delivers these cell-derived antigens directly to a recipient's own antigen presenting cells, resulting in highly selective activation of CD8+ cytotoxic T cells. Prior studies with viagenpumatucel-L (and related gp96-Ig vaccines) have shown a correlation between increases in CD8+ tumor infiltrating lymphocytes (TIL) and tumor response. Since the presence of TILs is one of the predictors for response to checkpoint inhibitors, the DURGA trial combining HS-110 with nivolumab was designed to explore the preclinical synergy between the two types of immunotherapy in an attempt to increase tumor inflammation and improve the response rates. Methods: Patients with advanced lung adenocarcinoma treated with at least one prior therapy are assigned to two cohorts based on baseline levels of TIL in patient biopsies: low TIL ( ≤ 10% CD8+ T cells) or high TIL ( > 10% CD8+ T cells). All patients receive standard of care nivolumab 3 mg/kg every 2 weeks and weekly HS-110 for 18 weeks or until disease progression or death. The 9-patient Phase 1b cohorts can be expanded to 30 patients in Phase 2 based on exhibited efficacy (Overall Response Rate (ORR)). The primary endpoint of the Phase 1b is safety and tolerability; the primary endpoint of the Phase 2 is ORR. Mandatory biopsies at baseline and Week 10 were used to track changes in TIL and PD-L1 staining. Peripheral blood mononuclear cells are evaluated by flow cytometry for detection of circulating leukocyte subsets, regulatory T cells, myeloid derived suppressor cells, activated T cells, and expression of immune checkpoint molecules on T cells. Cytokine and chemokine arrays from patient serum samples were also evaluated. Clinical trial information: NCT02439450 Clinical trial information: NCT02439450
Intellect Neurosciences, Inc. Engages Troy Rohn, PhD as Lead Scientific Advisor for TauC3 Antibody Program
Intellect Neurosciences, Inc. Engages Troy Rohn, PhD as Lead Scientific Advisor for TauC3 Antibody Program
NEW YORK, NY--(Marketwired - October 26, 2015) - Intellect Neurosciences, Inc. (OTCQB: ILNS) a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of rare neurodegenerative conditions, announced today that it has appointed Dr. Troy Rohn, Professor, Department of Biological Sciences, Boise State University, Boise, Idaho, as lead scientific advisor. Dr. Rohn has agreed to assist the company in shaping and guiding the company's TauC3 antibody program, and in particular, to identify one or more orphan diseases in which TauC3 is an appropriate target and for which the company's TauC3 antibody may be an effective therapeutic agent.
Dr. Rohn graduated in 1990 from the University of California at Davis with a B.S. in Physiology. He received his Ph.D. in Pharmacology from the University of Washington, Seattle in 1994. His interests include the role of apoptosis in neurodegenerative diseases. Dr. Rohn conducted Postdoctoral studies at UC Irvine at the Institute of Brain Aging and Dementia under the direction of Dr. Carl Cotman. Dr. Rohn continues to collaborate extensively with UC Irvine and in addition with Dr. Eliezer Masliah at UC San Diego.
The primary focus of Dr. Rohn's laboratory at Boise State University is the research of neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, Pick's disease, frontal temporal dementia and vascular dementia. Dr. Rohn has conducted numerous experiments with affinity-purified tau caspase cleavage antibodies and has written extensively about the TauC3 antibody, developed by Lester Binder's group at Northwestern University, which is under license to Intellect.
Elliot Maza, Chairman and CEO of Intellect, commented, "We are privileged and delighted that Dr. Rohn has agreed to join Intellect as lead scientific advisor. Dr. Rohn is uniquely capable to help us target our TauC3 antibody to one or more rare diseases. I look forward to working with him closely as we adjust the company's research focus exclusively on rare neurodegenerative diseases."
Dr. Rohn commented, "I am honored to assist Intellect meet its drug discovery and commercialization objectives. I am impressed by the company's strong science and commitment to advancing the research of caspase cleaved Tau and its role in neurodegenerative diseases."
About Intellect Neurosciences, Inc.
Intellect Neurosciences, Inc. is biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of rare neurodegenerative conditions, collectively known as proteinopathies. Our compounds under development include OX1, a high affinity, copper binding molecule that protects the body against free radicals. OX1 is licensed to Shire plc, which recently completed a single ascending dose Phase 1 study to evaluate the safety, tolerability and PK/PD of OX1 (renamed by Shire as "SHP622") in subjects with FA. Details of the study, entitled, "A Phase 1, Randomized, Double-blind, Placebo-controlled, Multicenter, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral VP 20629 in Adult Subjects with Friedreich's Ataxia", may be found at: www.clinicaltrials.gov, identifier NCT01898884. For more information, please visit www.intellectns.com.
Safe Harbor Statements Regarding Forward Looking Statements
The statements in this letter made by representatives of Intellect Neurosciences relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency of Intellect's cash and other capital resources, the continued development by Shire of SHP622 or its determination to seek Orphan Drug designation for the pharmaceutical product of SHP622 are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those discussed in Intellect's Annual Report on Form 10-K (file no. 333-128226) filed on October 13, 2015.
Shire said it ... was eyeing other potentially value-adding smaller deals
Shire still wants Baxalta but pursuing other deals
Drug group Shire (LON:SHP) is eyeing potential takeovers other than its stalled mega-bid for US rival Baxalta, but refused to name them as it posted third quarter results.
Shire said it was not solely focused on Baxalta and continued to evaluate other potentially value-adding smaller deals.
One of the possible acquisitions the company is rumoured to be working on is a US$90-per-share offer for US bone disease specialist Radius Health (NASDAQ:RDUS).
Chief executive Flemming Ornskov said in a telephone conference call to discuss its third quarter results that continued merger and acquisition activity was part of its drive to be a global leader in drugs for rare diseases and other speciality conditions.
But he declined to respond to the speculation about Radius or other potential acquisitions, saying the group had a policy of not commenting on specific deals. Radius also has not commented on the talk.
"Naturally we're not solely focused on Baxalta and we continue to pursue smaller but value-adding deals in core areas of interest to us," he said.
Ornskov added: "We're very active on that front and we continue to evaluate a number of other projects at any one time, but whether that be Radius or anyone else is one I'm not going to comment on."
Ornskov also declined to comment on whether Shire was preparing to increase its US$30.6bn approach to Baxalta following the latter's rejection of the deal as undervaluing it.
He said the company was "totally committed" to pursuing the deal , which is expected to achieve US$20bn in sales by 2020, but it was complex.
"This is an attractive opportunity but it is going to take some time," he said.
Commentators have pointed out that the bid for Baxalta in August was based on Shire's stock price at the time and would probably need to be increased in the light of a 17% fall in the price since then.
Shire has reportedly considered ways to sweeten the deal including getting cash to Baxalta shareholders sooner than its share buyback plan allows.
The company made its comments as it reported a 7% rise in third quarter product sales driven by strong performance from ADHD drug Vyvanse and hereditary angioedema treatments Cinryze and Firazyr.
Non-GAAP operating income at constant exchange rates rose 6% to US$725mln.
Ornskov said the group was in "robust health". It was investing in future growth drivers including several programmes that are set to enter phase three clinical trials in the months ahead.
"As we progress our ambition to be a rare diseases leader, we continue to believe the proposed acquisition of Baxalta represents a highly strategic combination, delivering an expected $20bn in sales by 2020 and a world-leading rare disease portfolio, " he added.
"Based on the strength of our core business, we are reiterating our recently upgraded full year Non GAAP diluted EPS guidance of mid-to-high single digit growth.”
Shares in Shire rose 3% or 133p to 4578p in early afternoon trading in London.
intellect neurosciences inc issues letter to shareholders
intellect neurosciences inc issues letter to shareholders
NEW YORK, NY -- (Marketwired) -- 10/20/15 -- Intellect Neurosciences, Inc. (OTCQB: ILNS) a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of rare neurodegenerative conditions, issued the following Letter to Shareholders from Elliot Maza, CEO.
Dear Intellect Shareholder,
I would like to update you regarding a recent strategic decision by our Board of Directors to direct our research efforts exclusively to rare diseases.
Background
Founded in 2005, Intellect's roots trace back to Mindset Biopharmaceuticals, Inc. ("Mindset") a company founded by Dr. Daniel Chain focused on developing disease modifying therapeutic agents for the treatment and prevention of Alzheimer's disease ("AD"). Early business development successes at Intellect included granting non-exclusive, worldwide, royalty-bearing licenses of the company's AD immunotherapy patent estate to global pharmaceutical companies developing products intended to treat AD.
OX1 -- from AD to FA
Among the assets that Intellect acquired from Mindset were the rights to OX1, a high affinity, copper binding molecule that protects the body against free radicals. OX1 was discovered by scientists at NYU and South Alabama Medical Science Foundation. Mindset had tested OX1 in 90 elderly healthy human subjects in Phase 1 trials. OX1 proved safe; no serious adverse events were reported. Intellect's intentions were to advance the development of OX1 for the treatment and prevention of AD.
In the first quarter of 2011, Intellect's Board of Directors agreed to management's recommendation to pivot from advancing OX1 for AD to Friedrich's Ataxia ("FA") a rare, hereditary, progressive, neurodegenerative disease caused by a defective gene affecting energy production. Intellect's decision to develop OX1 as a potential ground-breaking treatment for FA resulted from the convergence of two independent lines of research over several years: one relating to the general properties and mechanisms of action of OX1 and the other relating to the pathogenic mechanisms underlying FA, especially the important role of oxidative stress. These parallel developments helped uncover the strong potential of OX1 as a disease-modifying treatment for FA because of OX1's unique multimodal antioxidant properties, which prevent damage to cell membranes and the oxidation of proteins and DNA. We believed at the time, and continue to believe, that OX1 will prove disease modifying for FA and other neurodegenerative diseases.
In April 2011, we filed an orphan drug application with the Office of Orphan Products Development of the FDA to obtain Orphan Drug Designation for OX1 for the treatment of FA. Our efforts were supported by the Friedreich's Research Alliance ("FARA") the leading public, 501(c)(3), non-profit, tax-exempt organization dedicated to the pursuit of scientific research leading to treatments and a cure for FA. Although our application was not acted upon because of a lack of sufficient supporting data in the specified disease area of FA, the publicity generated in the pharmaceutical industry from our application stimulated significant discussions with large pharmaceutical companies interested in OX1 as a potential disease-modifying treatment for FA. These discussions culminated in a successful agreement in September 2011 with ViroPharma, Inc. (subsequently merged into Shire plc) pursuant to which we granted to ViroPharma an exclusive license regarding our licensed patents and patent applications related to OX1 for the treatment of FA and other diseases.
In February 2013, ViroPharma filed an investigational new drug application to permit initiation of a single ascending dose Phase 1 study to evaluate the safety, tolerability and PK/PD of OX1 (renamed by ViroPharma as "VP 20629" and subsequently by Shire as "SHP622") in subjects with FA. The study commenced in the United States in August 2013 and was completed in July 2015. Details of the study, entitled, "A Phase 1, Randomized, Double-blind, Placebo-controlled, Multicenter, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral VP 20629 in Adult Subjects with Friedreich's Ataxia", may be found at: www.clinicaltrials.gov, identifier NCT01898884.
As of July 2015, the final cohort of the Phase 1 study was completed and enrollment was closed. It is likely that results from this study will be shared by Shire later in 2015. Although there can be no assurance, we anticipate that Shire will continue the development of SHP622 and seek Orphan Drug designation for the pharmaceutical product.
TauC3 -- from AD to Rare Diseases
Caspase-cleaved TauC3 (also known as delta tau) is an abnormal form of Tau protein. Tau is the main component of the neurofibrillary tangles of AD, the pathological lesion that seems most directly related to disruption of neural systems.
In 2012, we licensed a TauC3 antibody from Northwestern University, acquiring exclusive global rights to develop and commercialize the antibody. In January 2014, we announced top line data showing initial proof of concept in a preclinical AD model indicating the antibody's potential to be disease modifying. The data showed that the TauC3 monoclonal antibody effectively engaged the target and reduced certain phosphorylated pathological forms of Tau, indicating that the treatment with the peripherally administered antibody had an effect in the brain and potentially is disease modifying.
Earlier this year, we announced the initiation of a sponsored research collaboration under the direction of Professor Bradley T. Hyman MD, PhD, Director, Massachusetts Alzheimer's Disease Research Center & Co-Director, Massachusetts General Hospital Memory Disorders Unit & John B. Penney Jr. Professor of Neurology, Harvard Medical School. The research, which is ongoing, has yielded important data regarding target engagement. We are preparing a new patent application encompassing this data, which will strengthen our proprietary position in the TauC3 antibody.
Last month, I proposed to our Board of Directors that we adjust the focus of our TauC3 research and pivot from AD to rare neurological diseases that qualify for orphan drug status. My recommendation was based on several factors, including: the ongoing research at Harvard, which is designed to examine the detailed molecular mechanism affecting propagation of Tau pathology in neurological diseases; discussions with leading academics in the scientific community who are intimately familiar with TauC3 and the TauC3 antibody that we licensed from Northwestern; and discussions with potential strategic partners in the pharmaceutical industry who expressed interest in our antibody if it were proven to be applicable to a rare disease.
I am pleased to announce that our Board of Directors has agreed to my recommendation that we redirect the company's strategic focus. Accordingly, we are planning to test our TauC3 monoclonal antibody in several orphan disease preclinical models in the near future.
As a result of the foregoing, Intellect will focus its future research efforts exclusively on discovering and advancing therapeutic agents for the treatment and prevention of rare neurological diseases. We believe that positioning the company as an "orphan drug" discovery engine will enable us to unlock the true potential of our assets.
Adjusted balance sheet -- Surrender of convertible preferred stock
On July 25, 2014, we entered into a stock purchase agreement with certain accredited investors whereby we issued 1,200 shares of Series F Convertible Preferred Stock and warrants to purchase 9,600,000 shares of common stock for gross proceeds of $1.2 million (the "Financing").
In connection with the Financing, one of our significant shareholders agreed to surrender all of its Series C Convertible Preferred Stock with accrued dividends of approximately $7.2 million. The surrender of this stock for minimal consideration results from efforts by our Board of Directors to align the enterprise value of the company as measured by the quoted value of our fully diluted share count with what we believe to be the intrinsic value of the company's assets. I thank this shareholder for its cooperation.
I look forward to updating you on developments related to Intellect's programs in the future. Thank you for your support.
Sincerely,
/s/ Elliot Maza
Chief Executive Officer and CFO
Safe Harbor Statements Regarding Forward Looking Statements
The Company intends to use the net proceeds of the financing for working capital purposes, including payment of ongoing study costs for its TauC3 antibody program.
FORM-8k Entry into a Material Definitive Agreement
I can't explain the relationship, but if I'm not mistaken, GT HK is NOT part of the US Ch 11 process (at least not directly).
It was written several times in some of the court docs and the May MOR states:
[1] The Debtors, along with the last four digits of each debtor’s tax identification number, as applicable, are: GT
Advanced Technologies Inc. (6749), GTAT Corporation (1760), GT Advanced Equipment Holding LLC (8329), GT
Equipment Holdings, Inc. (0040), Lindbergh Acquisition Corp. (5073), GT Sapphire Systems Holding LLC (4417),
GT Advanced Cz LLC (9815), GT Sapphire Systems Group LLC (5126), and GT Advanced Technologies Limited
(1721).
The same MOR lists Accounts receivable of 3,315 million $.
So, if all/any payments (as e.g. 10 million upfront payment when intercompany settlement is approved by court) from GT HK to GT US are additional, stockholders equity should be better than listed in the MOR of May.
We need just one more FA participant between the ages of 18 and 45 so we can complete the study.
This is from volunteer search at LivingWithAtaxia.org
Reply by Alan Thomas 17 hours ago
Dear friends,
Hope this finds you all doing well. Wanted to let you know that we are within a single participant of being able to complete another FA clinical trial effort. This is a phase I trial designed to evaluate dosage and safety of VP20629, a naturally occurring small molecular weight drug compound aimed at preventing oxidative stress to improve mitochondrial function in FA patients. VP20629 was initially advanced by ViroPharma and was known as OX-1. It is now being advanced by Shire Pharmaceuticals and is known as SHP622.
We need just one more FA participant between the ages of 18 and 45 so we can complete the study. If you or a family member have FA and are between 18 and 45 years of age, please consider participating. Please read the notice, below, and consider contacting one of the three trial sites to express interest.
If you are one of the 50 people who already participated in the Phase 1 study for VP20629/SHP622, we thank you for your time and are grateful for your help in pushing this research forward. We are now asking for the attention and consideration of 1 more person (ages 18-45) to participate in the final cohort to complete the study at one of three sites -- Emory University in Atlanta, the University of South Florida in Tampa, or the University of Iowa. Of note, this study requires a 10-day in-patient stay at the study site.
This is a Phase 1 study designed to evaluate dosage and safety of VP20629/SHP622. If you are interested and available to participate, please consider contacting the study coordinator at one of the sites listed below to help us complete this study.
Warm regards,
Ron
VP20629 – Safety and Pharmacology Study of VP20629 in Adults With FA
Drug: SHP622 (also known as VP20629 or OX1)
Sponsor: Shire (formerly initiated by ViroPharma)
Specific information on inclusion and exclusion criteria is available here: www.clinicaltrials.gov/ct2/show/NCT01898884.
Please call or email one of the sites below if you are interested in participating:
However, the repayment of the notes is based on projected ASF sales by GT HK.
And citi also proposes some adjustments to the settlement:
Subject: GTAT- Intercompany Counterproposal
Subject to FRE 408
In follow up to yesterday’s meeting, below please find Citi’s response to the DIP Lender’s counterproposal. Please note that this proposal remains subject to tax review.
Please forward to clients as appropriate.
Initial Payment
. $10 million upfront payment
Priority Note
. $22.5 million principal amount of note
. PIK at 12.5%
. 2 year maturity
. No amortization
. Not subject to set off or prepayment
. Secured by all assets of GT Hong Kong (including GT HK’s share of the furnace proceeds distributions, but no adequate protection, no segregated account; no restrictions on (GT HK’s use of cash)
. No cross default or acceleration to DIP
Contingent Note
. $124.8 million principal (subject to increase of accrued CSA costs going forward)
. First $40 million recourse general unsecured claim which will be reduced dollar for dollar by any payments under the contingent note); remainder is non-recourse and only right to payment is from ASF sale proceeds allocated to GT US under the contingent note
. PIK at 12.5%
. Secured by proceeds of ASF sales (including GT HK’s share of the distribution, but no adequate protection, no segregated account; no restrictions on GT Hk’s use of cash)
. No cross default or acceleration to DIP
. Citi will agree that it will not take the position that the priority and Contingent notes should not be valued for plan distribution purposes
Page 21
In addition, in the event of a chapter 7 of GT US, the chapter 7 trustee can elect to cancel the priority note and the contingent note in exchange for a one-time payment that is equal to the lesser of: (1) (GT HK cash and cash
equivalents on hand at the time of such election and 2) the amount that remains unpaid under the DIP after the DIP lenders have realized on all of their collateral other than the notes and any assets securing the notes.
GTAT (US) proposes according to the 8K to solve the licensing, royalty agreements between GT US and GT HK and Ch11 costs in the following way:
IN RE GT ADVANCED TECHNOLOGIES, INC. ET AL. (“Debtors”)
SETTLEMENT PROPOSAL REGARDING INTERCOMPAY CLAIMS
[...]
This terrn sheet (the Term Sheet”) sets forth the principal terms to be included in a global settlement of a variety of intercompany issues by and between GTAT Corp. (“GT US”) and GT Advanced Technologies Limited (“GT HK”) including. among other issues:
[...]
SETTLEMENT TERMS
1. GT HK owes to GT US approximately $25.8 million (through Q2 2015) on account of certain intercompany claims arising after the Petition Date (the GT HK Intercompany Administrative Claims”). In addition, if GT HK were to assume the ASF LA, the DSS/Poly LA, the CSA and the MSA, GT HK would owe to GT US cure costs totaling $131.5 million (through Q2 2015).
2. On the date the settlement agreement is approved by the Bankruptcy Court (the “Approval Date”). GT HK will
a. pay GT US $10 million in cash, and
b. issue to GT US a Priority Note in the amount of the difference between the GT HK Intercompany Administrative Claim and 10 million, which is estimated to be $15.8 million. The Priority Note will be an allowed, first priority administrative claim in GT HK’s chapter 11 case, which allowed claim shall not be subject to setoff or recoupment. The Priority Note will be secured by all assets of GT HK, will be payable in cash in equal monthly installments over the course of twelve months, and will bear interest at the rate of 12.5% per annum, payable in cash.
[...]
5. To cure prepetition defaults under lhe ASF LA, the DSS/Poly LA. the CSA and the MSA, on the Approval Date, GT HK will issue to GT US a Contingent Note ¡n the original principal amount of $ 131.5 million.
a. The Contingent Note will be payable solely by application of the Contingent Payment (i.e. from the proceeds of ASF furnace sales, as set forth in item 4 above), will hear PIK interest at the rate of 12.5% per annum, and will be secured solely by the proceeds of ASF furnace sales. Such lien ¡s junior to the lien in favor of GT US that secures the Priority Note.
[...]
In fact this is already the second "output of a crystal ball":
dbing Monday, 05/04/15 10:06:11 AM
Re: None
Post # of 18085
Outstanding shares up to 3.3 mill.scumbags diluting.same shit here
this post was about one week before the 10q came out where the 3.3 million outstanding shares were published for the first time (as far as I am aware).
Anyways, if the 10 mill for orphan drug designation is correct, that would be great - although it depends on shire and may take a while
Could UCI grant be used for ILNS Tauc3 research?
UCI receives $11 million grant to continue ground-breaking Alzheimer's research
April 16, 2015
Updated 11:01 p.m.
[...]
UC Irvine announced Thursday that the institute has received a five-year, $11 million grant from the National Institute on Aging to renew its status as one of 27 Alzheimer’s Disease Research Centers in the country and the only one in Orange County.
The award will allow the center to continue its programs targeting clinical and basic research as well as community and caregiver education programs, LaFerla said.
[...]
The center also does pharmacological research, studying the effectiveness of medications for Alzheimer’s patients. Currently, Alzheimer’s patients have limited options with drugs, most of which only have a moderate impact, McAleer said.
“We’re hoping future research shows the way to medications to prevent or effectively treat this disease,” he said.
------------------------------
Of course, this is pure speculation as the article does not explicitly state that the grant will be used for TauC3 research.
However, LaFerla did TauC3 research for ILNS:
ILNS website: Internal pipeline:
In January 2014, we announced top line data showing proof of concept in a preclinical Alzheimer's model indicating the antibody’s potential to be disease modifying. The study was conducted in collaboration with University of California, Irvine's Dr. Frank LaFerla, Chancellor's Professor and Chair, Neurobiology and Behavior School of Biological Sciences, Director, Institute for Memory Impairments and Neurological Disorders. The data showed that the TauC3 antibody effectively engaged the target and reduced certain phosphorylated pathological forms of Tau, indicating that the treatment with the peripherally administered antibody had an effect in the brain and is potentially disease modifying.
We have developed a detailed plan to corroborate these preliminary findings in additional models. This work will be outsourced to specialist contract research organizations and will involve collaboration with a leading AD investigator who has developed sophisticated models that are particularly well suited to test the TauC3 antibody.
Intellect Neurosciences Common Stock Approved for Trading on OTCQB
Intellect Neurosciences Common Stock Approved for Trading on OTCQB
Company Initiates Collaboration With Harvard Medical School to Undertake Further Studies With TauC3 Monoclonal Antibody Targeting a Secreted Form of Tau Protein
ENGLEWOOOD CLIFFS, NJ--(Marketwired - April 15, 2015) - Intellect Neurosciences, Inc. (OTCQB: ILNS) a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic and diagnostic agents for the treatment of Alzheimer's and other neurological diseases, today announced that its securities have been designated as trading on the OTCQB marketplace. Intellect has satisfactorily passed the requirements for eligibility, which include up to date reporting to the SEC, a minimum bid price test of one penny and an annual verification and management certification process providing additional information about the company's insiders, advisors and share count. As a result of the designation, among other things, Intellect investors will enjoy greater information availability through news and disclosure posted through the OTC Disclosure & News Service and transparent prices through full-depth of book with Real Time Level 2 quotes.
Recently, the Company announced that it has initiated a sponsored research collaboration with one of the foremost Alzheimer's disease research centers in the United States. The sponsored research collaboration is under the direction of Professor Bradley T. Hyman MD, PhD, Director, Massachusetts Alzheimer's Disease Research Center & Co-Director, Massachusetts General Hospital Memory Disorders Unit & John B. Penney Jr. Professor of Neurology, Harvard Medical School. The research is designed to examine the detailed molecular mechanism affecting propagation of tau pathology aimed at developing a novel treatment for Alzheimer's disease and other tauopathies.
Dr. Hyman is the Director of the Massachusetts Alzheimer's Disease Research Center. He directs the Alzheimer's disease research unit at the MassGeneral Institute for Neurodegenerative Disease (www.mghmind.org), with the goal of understanding the neuropathophysiologic and genetic factors that underlie dementia. His laboratory studies the anatomical and molecular basis of dementia in Alzheimer's disease and dementia with Lewy bodies. Dr. Hyman is the recipient of numerous awards in the field of Alzheimer's and related diseases, including the Metropolitan Life Award, the Potamkin Prize, a National Institute on Aging MERIT award, and an Alzheimer Association Pioneer Award.
"I am extremely proud that Intellect's common stock is trading on the OTCQB, a confirmation that our strategic plan of advancing our core programs and restructuring our capitalization is strengthening the company. The collaboration with Professor Hyman, the next step in development of our TauC3 program, should yield important new mechanistic insights that will attract interest from potential pharmaceutical partners," said Mr. Elliot Maza, Chairman and Chief Executive Officer of Intellect Neurosciences.
Safe Harbor Statements Regarding Forward Looking Statements
....
OTC Markets Group Welcomes Newly Verified OTCQB Companies – April 14
Apr 14, 2015
OTC Disclosure & News Service
New York, NY -
OTC Markets Group Inc. (OTCQX: OTCM), operator of Open, Transparent and Connected financial marketplaces, today announced the following companies are verified for trading on the OTCQB® Venture Marketplace:
....
Intellect Neurosciences, Inc. (OTCQB: ILNS) – Intellect Neurosciences is a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of neurodegenerative conditions, especially proteinopathies. These conditions include Alzheimer’s disease, Parkinson’s and Huntington’s disease, Frontotemporal Dementia and age related macular degeneration. The company’s internal drug discovery programs are focused on the therapeutic applications of monoclonal antibodies and antibody-drug conjugates. Intellect has granted licenses to global pharmaceutical companies covering several of the patents in its intellectual property portfolio, which will entitle the company to significant milestone payments and sales based royalties upon successful development and commercialization of the licensed drug candidates.
The patent and consequently the license agreement holds for Alzheimer's disease AND any other condition:
It's well known and accepted that the license agreement for the " Pfizer compound" a.k.a. ponezumab falls under the license agreement with ILNS .
However, Pfizer tries to argue that the license agreement is only for Alzheimer's disease, which is wrong!
Any usage for whatever clinical condition is protected by the patent US8173127 for which the milestone payment is due.
You have to look at the patent claims and you will see that it's not limited to Alzheimer's disease. See granted claim 7:
A method of forming a complex, said method comprising:
providing to the cerebrospinal fluid of an individual, an agent that is a monoclonal antibody, humanized antibody, chimeric antibody, scFv antibody, F(ab) antibody, or a fragment of the foregoing types of antibodies, which agent specifically binds to an epitope within residues 34-40 of an amyloid ß-peptide and which binds said amyloid ß-peptide but does not significantly bind amyloid precursor protein,
to form in said cerebrospinal fluid a complex comprising said agent and said amyloid ß-peptide.
It is obvious that by doing an iv infusion one is "providing to the cerebrospinal fluid of an individual, an agent that is a monoclonal antibody" and as this is not linked to AD, any use of ponezumab of Pfizer falls under the license agreement with ILNS.
Da_wiz, I doubt Montamero has any other sources than the ones that are available to all of us via internet.
He provided that list of potential catalysts for ILNS and I think he just used Evli investment instead of the possible options that were stated in the Evli PR of ILNS.
Also the term License TauC3 seems to be just a short statement for possible licensing agreements.
Sorry but I don't understand your question. ILNS closed at 0,01 yesterday do you refer to something in one of the posts that had been deleted?