: ARC-520 shows promise in chronic hepatitis B
ARC-520 shows promise in chronic hepatitis B
By: SHARON WORCESTER, Family Practice News Digital Network November 23, 2015
AT THE LIVER MEETING 2015 Vitals
Key clinical point: ARC-520, the first RNA interference?based drug to reach patients, produced deep and durable knockdown of viral antigens and DNA in chronic hepatitis B patients in a phase II study.
Major finding: In treatment-naive patients, the best observed quantitative hepatitis B surface antigen (qHBsAg) knockdown was 1.9 log (99%) in HBeAg-pos patients, and 0.7 log in HBeAg-neg patients (mean max, 1.2 log and 1.1 log, respectively).
Data source: A phase II study of 58 CHB patients. Disclosures: Dr. Yuen reported advisory committee or review panel participation with GlaxoSmithKline, Bristol-Myers Squibb, and Pfizer, and grant or research support from Roche, Bristol-Myers Squibb, Pfizer, and Gilead Science.
: Arrowhead Added to NASDAQ Biotechnology Index
Dec 14, 2015 Previous Release PDF Add to Briefcase Arrowhead Added to NASDAQ Biotechnology Index®
PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI) as part of the annual re-ranking which will become effective prior to market open on Monday, December 21, 2015.
The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The NASDAQ Stock Market® that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology and ranked on an annual basis. All securities in the NASDAQ Biotechnology Index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market and must meet certain eligibility requirements.
We have focused our resources primarily on the DPC? platform and on advancing our proprietary DPC?-enabled RNAi therapeutic candidates through clinical trials. Additionally, with our increased R&D headcount, Arrowhead now has the infrastructure, expertise, IP portfolio, chemistry, manufacturing and control (CMC) capabilities, and management that we believe is necessary to support potential partnerships and research collaborations with large biopharma companies from discovery stage through commercialization. http://ir.arrowheadresearch.com/sec.cfm
Arrowhead?s research and development operations are located in Madison, Wisconsin and are housed in two facilities. The main facility was built and equipped by Roche and was part of our 2011 acquisition of Roche?s RNA therapeutics business. A second research and development facility, located in a nearby Madison suburb, was opened in 2015 as operations expanded. Substantially all of the Company?s assets are located either in these facilities or in our corporate headquarters in Pasadena. A summary of our research and development facilities is provided below:
Wird hier bald Partnerforschung betrieben? massiver Pipelineausbau und Meilensteineinnahmen plus Umsatztanthiemen um die Bilanz zu stärken?
: Arrowhead: Feasibly achieving a functional cure fo
Monday, December 21, 2015 Arrowhead: Feasibly achieving a functional cure for chronic HBV Editors' Note: This article covers a stock trading at less than $10 per share and/or with less than a $500 million market cap. Please be aware of the risks associated with these stocks. http://biotechwithpotential.blogspot.ro/
Item 1.01 Entry into a Material Definitive Agreement
On January 8, 2016, we entered into a new lease for a Madison, Wisconsin research facility. The 10-year office building lease between our subsidiary, Arrowhead Madison Inc. and University Research Park, Incorporated is for approximately 60,000 square feet of office and laboratory space located at 502 South Rosa Road, Madison, Wisconsin, and this lease will replace our current research facility office lease also with University Research Park, Incorporated for property located at 465 Science Drive Suite C, Madison Wisconsin. The increased capacity of this new facility compared to our current research facilities will accommodate increased research and development personnel for our expanding pipeline of current and future drug candidates. http://ir.arrowheadresearch.com/...ID=1564590-16-11873&CIK=879407
Arrowhead's ARC-AAT Granted EMA Orphan Drug Designation
PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to ARC-AAT for treatment of congenital alpha-1 antitrypsin deficiency. ARC-AAT was also previously granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) in 2015.
Orphan Drug Designation from the EMA allows Arrowhead to benefit from a number of incentives, such as reduced regulatory fees, protocol assistance, and market exclusivity, to develop a medicine for the treatment of a rare disease affecting not more than five in 10,000 people in the European Union.
"ARC-AAT has the potential to provide patients and physicians with a much needed treatment option for liver disease associated with alpha-1 antitrypsin deficiency, a rare genetic disorder. We are pleased that the EMA has granted Orphan Drug Designation and we view this as an important regulatory milestone for the program," said Bruce Given, M.D., Arrowhead chief operating officer. http://ir.arrowheadresearch.com/releasedetail.cfm?ReleaseID=950654
kann sich hier jemand vorstellen das die DPC Technologie auf Genlieferung erweitert wird? So wie ich gelesen habe müssen die Cash9proteine auch geliefert werden. Hier schreiben sie von Lipidnanopartikeln. so wie hier in der Abbildung in vivo? http://crisprtx.com/our-programs/therapeutic-approach.php
DPC soll ja besser sein? Advantages over Lipid-based Systems
We believe our DPC technology is radically different from standard liposomal or lipid nanoparticle siRNA delivery systems used by the majority of RNAi therapeutics companies. DPCs are smaller than lipid-based systems, enabling more efficient distribution from the vasculature to the target tissue. DPCs can use targeting ligands for cell-type specific delivery, which has yet to be achieved with the lipid-based systems used in clinical development programs. The modular nature of DPCs allows each component to be optimized for higher efficacy and lower toxicity. As a polymer-based system, DPCs are fundamentally different from lipid-based systems. This has the potential to open up an entirely new class of macromolecules to enable siRNA delivery. http://www.arrowres.com/technology/dynamic-polyconjugates
Also kann sich jemand vorstellen das hier Deals kommen?
.desweiteren könnten mit DPC auch alle anderen moleküle ohne nebenwirkungen geliefert werden..sie sind nur mit RNAI zur zeit voll ausgelastet und warten wohl auf anständigen Cashflow damit hier angeschoben werden kann?
jup ein paar Partnerschaften müssen eingetütet werde...ist wohl nur ne frage der Zeit. Irgendwas muss ja kommen, sonnst würden sie keine größere anlage anmieten die zudem noch in Nachbarschaft von Roche ist...:-)
Do we have capital? Yes. We have enough to run through at least the next 12 months while pushing our lead programs as fast as possible and continuing to work on our pipeline. Do we have access to additional capital? Yes, through a number of sources.
We have clearly demonstrated ARC-520 and ARC-AAT are active and well tolerated in humans. And 2016 is full of value inflection points. These include treating over 200 patients in multiple Phase 2 studies of ARC-520, some of which are open label; the introduction of ARC-521 into the clinic and expect a quick progression of Phase 1/2 studies, the release of ARC-AAT healthy volunteer and patient data, and progression into Phase 2 studies. These are important for rapid value creation and therefore important to investors.
We're also at a point in development and platform validation that we are increasingly attractive partner to larger companies. Many companies looking for exposure to the areas we are addressing with current candidates would be interested in our ongoing programs. Similarly, companies looking to address areas in which we do not have active programs will find Arrowhead an attractive discovery and development partner.
We have broad IP coverage through internal development, the Novartis transaction and the Rose transaction. We have a delivery platform that has demonstrated extremely deep target knockdown in humans and arguably the best safety profile in the field. We are capable of addressing both hepatic and extra-hepatic targets, we are capable of both IV and subcutaneous administration and we have demonstrated very rapid development timelines.
As we have mentioned, 2016 is set up to be an exciting year for us across multiple fronts. I think we will start to see answers to questions that have vexed medicine for some time now, and we look forward to regular communication with The Street. I think 2016 is a big year for us and I also think we will surprise some people. http://files.shareholder.com/downloads/...R_FQ1_2016_script_FINAL.pdf
Eindruck das hier dicke Partnerschaften in Drogenentdeckung und Entwicklung in rnai und andere Drogen in der mache sind...Partnerschaften aus aktuellen Programmen dauern noch weil sie mehrwert durch klinischen nachweiß schaffen wollen...:-))
Ich hoffe doch das noch vor der Haupversammlung am 8. März eine Partnerschaft verkündet wird und unser Board wiedergewählt wird..:-)))
für hunderte indikationen mit einem Umsatzpotential von mehr als 1000 Millarden Dollar trifft auf eine MK von 200 mios ....risiko=keine Zulassungen...ich würde mich nur ärgern nicht dabei zu sein und bin mit ein paar Kröten mit dabei :-)
wer ist mit rein, bei 3,20 euro? hab die blattzahl verdoppelt und würde mal sagen: das papier fiel unverdient in sippenhaft und könnte ein move machen, der manches derivat alt aussehen lässt. schaun wir mal.
hier steht ein Neubau einer 45.000 der Anlage..gibts die jetzt zur neuen 60.000 oben drauf.:-) und wo kommt die Kohle her..:-) Arrowhead Research expanding its lab space in Madison Arrowhead Research Corp., a California company that is aiming to develop a cure for hepatitis B, is planning to expand its research facilities in Madison with construction of a 45,000 square-foot laboratory facility.
"This expansion shows confidence in their method of treatment, R&D investment, and in Wisconsin as an ecosystem of research," said Brian Moeller, operations manager at BioForward, the trade association for the state's biotech industry.
ein paar Eindrücke von der Hauptversammlung von einem YMB User
Notes from the Shareholder Meeting.
I just got home.
DPC; Dr A thinks that since they have tested the DPC in over 100 patients that it has been de-risked and they are aggressively looking for outside partners with their drugs to partnership with.
ARWR vs ALNY & ABUS; ARWR's DPC has no side effects, the delivery platform is gone from the body in about 24 hrs., the drug last over 30 days per treatment without side effects.
ALNY has to first inject with steroids then administer their IV drug over a 2 hour period every week and has side effects.
ABUS has 8 different drugs to combo to try and find an effective treatment.
ARC-520; 2001e started a little bit before announcement. Aggressively looking for a partner has been talking to MERK, Johnson & Johnson and GILD and expecting interest from other parties after open label results.
ARC-521; Should be in clinic by end of second quarter (June).
ATT; Phase 1 on going working on dosage. Aggressively looking for a partner.