EyePoint Pharmaceuticals (vorher: PSIVIDA) startet durch !! (Seite 216)
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ISIN: AU000000PVA7 · WKN: A0Q4DA
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http://www.clinicaltrials.gov/ct2/show/NCT00247260?term=psiv…
hier nochmals der Link in der Hoffnung, dass er jetzt funktioniert.
hier nochmals der Link in der Hoffnung, dass er jetzt funktioniert.
Antwort auf Beitrag Nr.: 44.121.849 von wonner am 09.02.13 07:35:13Hallo wonner,
[urlhttp://www.clinicaltrials.gov/ct2/show/NCT00247260?term=psiv…[/url]
Es müsste sich um diese Studie handeln. Ich habe die schon einige Zeit beobachtet, aber es hat sich dort seit Jahren nichts mehr getan. Letztes update war 2007.
Wäre natürlich toll, wenn es mit BrachSil endlich in Phase 3 gehen würde.
Gruß
WMW
[urlhttp://www.clinicaltrials.gov/ct2/show/NCT00247260?term=psiv…[/url]
Es müsste sich um diese Studie handeln. Ich habe die schon einige Zeit beobachtet, aber es hat sich dort seit Jahren nichts mehr getan. Letztes update war 2007.
Wäre natürlich toll, wenn es mit BrachSil endlich in Phase 3 gehen würde.
Gruß
WMW
Ich hoffe mal das wir 2013 die 5 $ wieder sehen ,oder was meint Ihr so.
Grüße aus Sachsen!
Grüße aus Sachsen!
Antwort auf Beitrag Nr.: 44.121.402 von chris6com am 08.02.13 22:11:52noch ein Nachtrag.
In USA geht nur der Handel A0Q4DQ.
Solltest Du Aktien mit A0Q4DA haben musst Du sie hier loswerden und in USA mit Endung "Q" neu erwerben. Du kannst in USA erworbene Aktien auch nur an diesem Lagerort handeln. Ein umlagern nach Frankfurt kostet Zeit und Geld. Aber das würde ich sowieso nicht machen. Nur zur Kenntnisnahme.
In USA geht nur der Handel A0Q4DQ.
Solltest Du Aktien mit A0Q4DA haben musst Du sie hier loswerden und in USA mit Endung "Q" neu erwerben. Du kannst in USA erworbene Aktien auch nur an diesem Lagerort handeln. Ein umlagern nach Frankfurt kostet Zeit und Geld. Aber das würde ich sowieso nicht machen. Nur zur Kenntnisnahme.
Ich kaufe über Consors in New York.
Du musst allerdings eine gewisse Anzahl an Trades abwickeln ( ich glaube ca. 50 pro Jahr), dann bist Du Trader und bezahlst auch bei Teilabwicklungen nur einmal die Gebühr. Aber am besten direkt dort mal anrufen und beraten lassen. Auch Limits sind kostenlos.
Achtung: Wenn Du einen Depotwechsel zu Consors machst und die 4 % Zinsen für das Tagesgeldkonto nimmst, zahlst Du für jede Teilausführung. Entweder das eine oder das andere.
Bei den normalen Banken kann man den Handel in USA vergessen.
Ich hoffe Du kannst was mit anfangen.
Du musst allerdings eine gewisse Anzahl an Trades abwickeln ( ich glaube ca. 50 pro Jahr), dann bist Du Trader und bezahlst auch bei Teilabwicklungen nur einmal die Gebühr. Aber am besten direkt dort mal anrufen und beraten lassen. Auch Limits sind kostenlos.
Achtung: Wenn Du einen Depotwechsel zu Consors machst und die 4 % Zinsen für das Tagesgeldkonto nimmst, zahlst Du für jede Teilausführung. Entweder das eine oder das andere.
Bei den normalen Banken kann man den Handel in USA vergessen.
Ich hoffe Du kannst was mit anfangen.
Trading Spotlight
Today's news came and went without much notice in the market. PSDV isn't saying a word; until the deal closes, typical, tight lipped PSDV.
NeuroDiscovery to acquire Enigma Therapeutics Ltd
Source Press Release
Company pSivida, NeuroDiscovery
Tags Acquisition
Date February 07, 2013
Enigma Therapeutics (“Enigma”) is a cancer company based in the UK targeting the global cancer brachytherapy market which is predicted to be $1.6 billion by 2015
Enigma has an exclusive global license for BrachySil (to be renamed Oncosil) containing certain radioactive isotopes for use in all solid tumors from pSiMedica Ltd, a subsidiary of pSivida Corp (ASX Code PVA)
Over the previous 10 years significant investment into the efficacy and safety of the product
First target disease is pancreatic cancer
Previously completed four human clinical studies in pancreatic and liver cancer
Potentially Phase III ready, subject to regulatory discussions
CE mark application as soon as possible, potentially during 2013
Capital raising of $1.5 million to accompany the acquisition resulting in available working capital of ~$3.5 million
NeuroDiscovery Ltd (ASX: NDL), is pleased to advise that, consistent with its strategy to diversify through acquisition, the Company has today entered into a Sale and Purchase Agreement to acquire 100% of Enigma Therapeutics Ltd, a UK based cancer company.
Engima’s lead product, Oncosil , is a targeted brachytherapy treatment being developed under an exclusive world-wide license from pSiMedica for its proprietary BrachySil product utilizing defined radioactive isotopes. pSiMedica is a subsidiary of USA based pSivida Corp. (ASX Code PVA).
Having already completed two Phase II studies in pancreatic cancer, a Phase III study is planned to potentially commence in calendar 2013, subject to discussions with relevant regulatory authorities. In addition, the Company will also apply for a CE Mark as soon as possible following discussions with relevant regulatory authorities.
Key information on the Enigma technology, intellectual property and previous studies, including two studies in liver cancer, are included in Appendix A.
NeuroDiscovery will, subject to shareholder approval :
Issue 75 million shares to purchase 100% of Enigma Therapeutics Ltd.
Raise an additional AUS$1.5 million via the placement of 60 million shares at $0.025. The placement will be managed by Forrest Capital and is completed subject to shareholder approval.
Issue 25 million Advisor Options (unlisted) to Forrest Capital (or its nominees) exercisable at $0.05 per option on or before 30 June 2016.
Issue one million options to each director on the same terms and conditions as Advisor options.
A detailed Notice of Meeting will be mailed to all shareholders as soon as possible.
Oncosil - Product Background
Oncosil (in previous trials referred to as Brachysil) is the active implantable (radiological) medical device containing radioactive phosphorus atoms ( 32 P), which are closely bonded within an internal silicon microcrystalline structure. ( 32 P), is a beta emitter and as such is highly cytotoxic over a short range (approximately 1 cm) but has poor penetration beyond this range. It is therefore well suited for local administration to tumors to maximize its local effects while minimizing systemic toxicity.
Oncosil is being developed for direct intratumoral implantation into solid tumors. The microparticles are designed to remain localised within the tissues and deliver a retained and targeted dose of beta radiation. The product is easy to use and administered via ultrasound guided endoscopy.
Oncosil is being developed as a medical device, not a pharmaceutical product, enabling a potentially faster route to marketing approval. The initial indication for the product is pancreatic cancer. However, many other solid tumours are potentially treatable with this therapy.
Enigma Initial Target Market
Engima’s strategy will be to establish proof of principle in man for Oncosil in pancreatic cancer, prior to potentially targeting further wider indications for the product. Pancreatic cancer is the fourth largest cause of cancer death in the US and Europe with an annual incidence of over 30,000 in the US and over 50,000 in the EU.
Other potential target markets include not only the use of ( 32 P) in BrachySil but also a number of other radioisotopes approved under the assignment and license agreement.
Previous Phase IIa and Phase IIb Clinical Data in Pancreatic Cancer
Both Phase IIa and Phase IIb clinical studies on Oncosil have already been completed.
A brief summary of both trial results is provided below.
Phase IIa
The Phase IIa study in patients with late stage, inoperable pancreatic cancer was completed in January 2008. This was a fixed dose study in 17 patients, with the primary objective of evaluating the safety of the product and secondary objective of assessing initial efficacy based on overall survival and progression free survival.
The trial was conducted in London (UK) and Singapore. The results from the trial, based on 24 weeks follow-up, demonstrated:
Product safety
No clinically significant product-related adverse events.
No significant systemic leakage of (32P), from the site of implantation.
Product efficacy
CT scan analysis of patients demonstrated significant tumouricidal activity with a disease control rate of 82%.
Reduction in pain associated with pancreatic cancer.
Median progression free survival was 121 days.
Median overall survival was 309 days.
The trial concluded that patients with pancreatic cancer receiving Oncosil (who are also receiving standard concomitant chemotherapy with gemcitabine) is easily deliverable, tolerable and potentially effective.
Phase IIb
A dose ranging study was conducted to determine the optimal dose of Oncosil. Six patients were enrolled in London (UK) and Birmingham (UK) and received either 200Gy or 400Gy as a single injection. The study was completed in August 2009.
Product safety
No clinically significant product-related adverse events.
No significant systemic leakage of (32P), from the site of implantation.
Product efficacy
CT scan analysis of patients demonstrated significant tumouricidal activity with a disease control rate of 100%.
Optimized Dose
The highest dose studied, 400Gy (4 times the dose used in the Phase IIa trial) was determined to be the optimal dose.
Enigma Clinical Program and Regulatory Strategy Moving Forward Under the Licence
Engima plans to enter discussions with regulatory authorities in UK with the view to obtaining a potential CE Mark for Oncosil as soon as practicable.
The company also intends to conduct a potential Phase III study and discussions with regulatory authorities and manufacturers will take place as soon as reasonably practicable. It is anticipated this trial may have approval to commence during 2013.
Additional Indications for Enigma Oncosil
In addition to pancreatic cancer, Oncosil is potentially applicable to a wide range of solid tumor indications, including tumors of the liver. pSivida previously conducted a Phase I/II and Phase IIa clinical trial in primary liver cancer which again demonstrated it was well safe and tolerated. The Phase IIa concluded that additional studies may be warranted to evaluate clinical safety and efficacy.
Enigma has the right to reference this data and information under the license agreement with pSiMedica.
Enigma Oncosil Manufacturing Process
Enigma has a GMP-compliant process for the production of Oncosil with a number of manufacturing partners responsible for different aspects of the process. The starting material for the process is polycrystalline silicon which is an inexpensive and abundant raw material. The early stages of the Oncosil manufacturing process are on “cold” (ie non -radioactive) materials and partners are responsible for the atomisation, size definition and nanostructuring of the 30 micron particles and for the ( 32 P), activation, formulation, packaging and distribution of Oncosil to trial sites.
Enigma Intellectual Property
Oncosil is covered by a comprehensive portfolio of both granted patents and patent applications which all fall within the assignment and license agreement from pSiMedica. These provide broad product and technology-related protection for Enigma products and on-going development strategies.
NeuroDiscovery to acquire Enigma Therapeutics Ltd
Source Press Release
Company pSivida, NeuroDiscovery
Tags Acquisition
Date February 07, 2013
Enigma Therapeutics (“Enigma”) is a cancer company based in the UK targeting the global cancer brachytherapy market which is predicted to be $1.6 billion by 2015
Enigma has an exclusive global license for BrachySil (to be renamed Oncosil) containing certain radioactive isotopes for use in all solid tumors from pSiMedica Ltd, a subsidiary of pSivida Corp (ASX Code PVA)
Over the previous 10 years significant investment into the efficacy and safety of the product
First target disease is pancreatic cancer
Previously completed four human clinical studies in pancreatic and liver cancer
Potentially Phase III ready, subject to regulatory discussions
CE mark application as soon as possible, potentially during 2013
Capital raising of $1.5 million to accompany the acquisition resulting in available working capital of ~$3.5 million
NeuroDiscovery Ltd (ASX: NDL), is pleased to advise that, consistent with its strategy to diversify through acquisition, the Company has today entered into a Sale and Purchase Agreement to acquire 100% of Enigma Therapeutics Ltd, a UK based cancer company.
Engima’s lead product, Oncosil , is a targeted brachytherapy treatment being developed under an exclusive world-wide license from pSiMedica for its proprietary BrachySil product utilizing defined radioactive isotopes. pSiMedica is a subsidiary of USA based pSivida Corp. (ASX Code PVA).
Having already completed two Phase II studies in pancreatic cancer, a Phase III study is planned to potentially commence in calendar 2013, subject to discussions with relevant regulatory authorities. In addition, the Company will also apply for a CE Mark as soon as possible following discussions with relevant regulatory authorities.
Key information on the Enigma technology, intellectual property and previous studies, including two studies in liver cancer, are included in Appendix A.
NeuroDiscovery will, subject to shareholder approval :
Issue 75 million shares to purchase 100% of Enigma Therapeutics Ltd.
Raise an additional AUS$1.5 million via the placement of 60 million shares at $0.025. The placement will be managed by Forrest Capital and is completed subject to shareholder approval.
Issue 25 million Advisor Options (unlisted) to Forrest Capital (or its nominees) exercisable at $0.05 per option on or before 30 June 2016.
Issue one million options to each director on the same terms and conditions as Advisor options.
A detailed Notice of Meeting will be mailed to all shareholders as soon as possible.
Oncosil - Product Background
Oncosil (in previous trials referred to as Brachysil) is the active implantable (radiological) medical device containing radioactive phosphorus atoms ( 32 P), which are closely bonded within an internal silicon microcrystalline structure. ( 32 P), is a beta emitter and as such is highly cytotoxic over a short range (approximately 1 cm) but has poor penetration beyond this range. It is therefore well suited for local administration to tumors to maximize its local effects while minimizing systemic toxicity.
Oncosil is being developed for direct intratumoral implantation into solid tumors. The microparticles are designed to remain localised within the tissues and deliver a retained and targeted dose of beta radiation. The product is easy to use and administered via ultrasound guided endoscopy.
Oncosil is being developed as a medical device, not a pharmaceutical product, enabling a potentially faster route to marketing approval. The initial indication for the product is pancreatic cancer. However, many other solid tumours are potentially treatable with this therapy.
Enigma Initial Target Market
Engima’s strategy will be to establish proof of principle in man for Oncosil in pancreatic cancer, prior to potentially targeting further wider indications for the product. Pancreatic cancer is the fourth largest cause of cancer death in the US and Europe with an annual incidence of over 30,000 in the US and over 50,000 in the EU.
Other potential target markets include not only the use of ( 32 P) in BrachySil but also a number of other radioisotopes approved under the assignment and license agreement.
Previous Phase IIa and Phase IIb Clinical Data in Pancreatic Cancer
Both Phase IIa and Phase IIb clinical studies on Oncosil have already been completed.
A brief summary of both trial results is provided below.
Phase IIa
The Phase IIa study in patients with late stage, inoperable pancreatic cancer was completed in January 2008. This was a fixed dose study in 17 patients, with the primary objective of evaluating the safety of the product and secondary objective of assessing initial efficacy based on overall survival and progression free survival.
The trial was conducted in London (UK) and Singapore. The results from the trial, based on 24 weeks follow-up, demonstrated:
Product safety
No clinically significant product-related adverse events.
No significant systemic leakage of (32P), from the site of implantation.
Product efficacy
CT scan analysis of patients demonstrated significant tumouricidal activity with a disease control rate of 82%.
Reduction in pain associated with pancreatic cancer.
Median progression free survival was 121 days.
Median overall survival was 309 days.
The trial concluded that patients with pancreatic cancer receiving Oncosil (who are also receiving standard concomitant chemotherapy with gemcitabine) is easily deliverable, tolerable and potentially effective.
Phase IIb
A dose ranging study was conducted to determine the optimal dose of Oncosil. Six patients were enrolled in London (UK) and Birmingham (UK) and received either 200Gy or 400Gy as a single injection. The study was completed in August 2009.
Product safety
No clinically significant product-related adverse events.
No significant systemic leakage of (32P), from the site of implantation.
Product efficacy
CT scan analysis of patients demonstrated significant tumouricidal activity with a disease control rate of 100%.
Optimized Dose
The highest dose studied, 400Gy (4 times the dose used in the Phase IIa trial) was determined to be the optimal dose.
Enigma Clinical Program and Regulatory Strategy Moving Forward Under the Licence
Engima plans to enter discussions with regulatory authorities in UK with the view to obtaining a potential CE Mark for Oncosil as soon as practicable.
The company also intends to conduct a potential Phase III study and discussions with regulatory authorities and manufacturers will take place as soon as reasonably practicable. It is anticipated this trial may have approval to commence during 2013.
Additional Indications for Enigma Oncosil
In addition to pancreatic cancer, Oncosil is potentially applicable to a wide range of solid tumor indications, including tumors of the liver. pSivida previously conducted a Phase I/II and Phase IIa clinical trial in primary liver cancer which again demonstrated it was well safe and tolerated. The Phase IIa concluded that additional studies may be warranted to evaluate clinical safety and efficacy.
Enigma has the right to reference this data and information under the license agreement with pSiMedica.
Enigma Oncosil Manufacturing Process
Enigma has a GMP-compliant process for the production of Oncosil with a number of manufacturing partners responsible for different aspects of the process. The starting material for the process is polycrystalline silicon which is an inexpensive and abundant raw material. The early stages of the Oncosil manufacturing process are on “cold” (ie non -radioactive) materials and partners are responsible for the atomisation, size definition and nanostructuring of the 30 micron particles and for the ( 32 P), activation, formulation, packaging and distribution of Oncosil to trial sites.
Enigma Intellectual Property
Oncosil is covered by a comprehensive portfolio of both granted patents and patent applications which all fall within the assignment and license agreement from pSiMedica. These provide broad product and technology-related protection for Enigma products and on-going development strategies.
Kann mir jemand sagen wo man am besten Aktien dieses Unternehmens kaufen kann. Hier an den deutschen Börsen findet ja so gut wie kein Handel statt und über Nasaq fallen hohen Gebühren an :-(
Feb 8, 2013, 10:04am EST
pSivida reports Q2 net loss
Enlarge
President and CEO Paul Ashton pSivida has recently started to transition from a licensed-based company, relying exclusively on partnerships, to developing its own products in-house as a speciality pharmaceutical company.
Stock in pSivida Corp. (Nasdaq:PSDV )dipped slightly Thursday after the company reported a net loss of $2.6 million, or 11 cents per share, for the three months that ended in December.
The Watertown-based company, specializing in drugs and delivery products for back-of-the-eye diseases, reported after the close of markets on Wednesday that it took in $585,000 in revenue for the second quarter of its 2013 fiscal year, down from $630,000 from the same period in 2011. At the same time, it spent $3.2 million, split evenly between research and development and administrative expenses.
The net loss was down significantly from a loss last year for the same period of $17.6 million.
President and CEO Paul Ashton said in a conference call Thursday morning that the company has recently started to transition from a licensed-based company, relying exclusively on partnerships, to developing its own products in-house as a speciality pharmaceutical company.
“Of course, I will still look into collaboration where it’s appropriate,” he said. “But increasingly, we look to develop our own products.”
The company has developed an injectable, non-erodible, intravitreal implant designed to release a drug for up to three years. Based on the insert, the company is now developing treatment for posterior uveitis, a swelling and irritation of the middle layer of the eye which affects just under 200,000 people in the U.S. and can cause pain and blindness. The U.S. Food and Drug Administration recently cleared pSivida’s investigational new drug application to treat posterior uveitis, clearing the way to move directly to two Phase III trials under which we would enroll a total of 300 patients.
Original und Seite2 gibt es hier:
http://www.bizjournals.com/boston/blog/bioflash/2013/02/psiv…
pSivida reports Q2 net loss
Enlarge
President and CEO Paul Ashton pSivida has recently started to transition from a licensed-based company, relying exclusively on partnerships, to developing its own products in-house as a speciality pharmaceutical company.
Stock in pSivida Corp. (Nasdaq:PSDV )dipped slightly Thursday after the company reported a net loss of $2.6 million, or 11 cents per share, for the three months that ended in December.
The Watertown-based company, specializing in drugs and delivery products for back-of-the-eye diseases, reported after the close of markets on Wednesday that it took in $585,000 in revenue for the second quarter of its 2013 fiscal year, down from $630,000 from the same period in 2011. At the same time, it spent $3.2 million, split evenly between research and development and administrative expenses.
The net loss was down significantly from a loss last year for the same period of $17.6 million.
President and CEO Paul Ashton said in a conference call Thursday morning that the company has recently started to transition from a licensed-based company, relying exclusively on partnerships, to developing its own products in-house as a speciality pharmaceutical company.
“Of course, I will still look into collaboration where it’s appropriate,” he said. “But increasingly, we look to develop our own products.”
The company has developed an injectable, non-erodible, intravitreal implant designed to release a drug for up to three years. Based on the insert, the company is now developing treatment for posterior uveitis, a swelling and irritation of the middle layer of the eye which affects just under 200,000 people in the U.S. and can cause pain and blindness. The U.S. Food and Drug Administration recently cleared pSivida’s investigational new drug application to treat posterior uveitis, clearing the way to move directly to two Phase III trials under which we would enroll a total of 300 patients.
Original und Seite2 gibt es hier:
http://www.bizjournals.com/boston/blog/bioflash/2013/02/psiv…
Antwort auf Beitrag Nr.: 44.112.332 von gogo26 am 07.02.13 06:18:27Danke für diese Nachricht. Ohne diesen Aston oder wie der heisst geht überhaupt nichts hier.
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