Klein,aber fein: Adeona Pharmaceuticals
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Jetzt muß nur noch einer erklären, wieso Adeona fällt nach diesen Nachrichten. Nichts Negatives, alles im grünen Bereich.
Adeona Announces Positive Alzheimer's Subgroup Analysis that Supports Additional Clinical Study of Proprietary Zinc-Based Therapy
Kurz zusammengefasst: Bei einer Untergruppe der bisherigen Studie wurden signifikant positive Ergebnisse festgestellt, sodass AEN jetzt eine weitere Studie in Auftrag gibt.
20 % PLUS. Ist doch mal was nach der Watschn von Fred Feinbein, oder?
ist, ist jedem klar. Da die Studie nun wieder Hoffnung macht, sollten nicht gleich wieder alle schmeißen, falls in den nächsten zwei Tagen ein Dödelanalyst kommt und alles schlecht redet.
Ich habe mir mal die Kommentare zu Human Genome Siences durchgelesen. Da kam im März 09 eine positive Analyse, trotzdem schmierte die Aktie um 40% ab. Dann waren da noch 1 Mrd Schulden und unser Chalifmann3 fragte sogar, ob die Firma überleben wird. Fast verständlich, wenn man den Kurs von Mai 08 zu 4 Euro mit dem von März 09 zu 39 Cent vergleicht. Doch was passierte dann? Bis August 09 stand der Kurs bei 10 Euro und stieg auf über 20 Euro. Natürlich kein Trost für den Kurs von 2001 bei 75 Euro.
Ob wir bei Adeona die Bodenbildung zwischen 50 und 60 Cent gesehen haben weiß keiner. Die Studie wird noch lange laufen. Doch die Aussicht auf Erfolg sollte uns bei der Stange halten.
Da die Studie nun wieder Hoffnung macht, sollten nicht gleich wieder alle schmeißen
Tja, haben sie aber am Freitag, diese A... Kurs steht wieder bei 0,85 USD.
Adeona Pharmaceuticals and Intrexon Announce Worldwide Exclusive Collaboration for Synthetic DNA-based Therapy for Pulmonary Arterial Hypertension
ANN ARBOR, Mich., and GERMANTOWN, Md., Nov. 21, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative disease-modifying medicines for serious illnesses, and the Human Therapeutics Division of Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, announced today the formation of a global exclusive channel collaboration through which Adeona intends to develop and commercialize a DNA-based therapeutic using Intrexon's UltraVector® platform and RheoSwitch Therapeutic System® for the treatment of pulmonary arterial hypertension (PAH).
Under the collaboration, Adeona will utilize Intrexon's advanced transgene engineering platform for the controlled, precise and continuous in vivo cellular production of prostaglandin synthase (PGIS), a specific effector enzyme that regulates the production of prostacyclin. PGIS expression is decreased in the lungs of PAH patients and deficiency in prostacyclin production is strongly implicated in PAH. Prostacyclin is a short-acting vasodilator and inhibitor of platelet aggregation that has demonstrated a survival benefit in primary pulmonary hypertension patients when administered by continuous central venous catheter infusion (p<0.003).[i] DNA-based in vivo expression of PGIS has demonstrated the ability to increase prostacyclin levels and improve survival in animal models of PAH.[ii]
Intrexon employs its modular genetic engineering platform in the areas of therapeutics, protein production, animal sciences, industrial products, and agriculture products. The exclusive channel collaboration between Intrexon and Adeona has been established specifically for the in vivo production of PGIS for PAH. Under the collaboration, Intrexon will be responsible for technology discovery efforts and managing the patent estate as well as for certain aspects of manufacturing. Adeona will be responsible for conducting preclinical and clinical development of candidates, as well as for other aspects of manufacturing and the commercialization of the candidate product.
Intrexon's core synthetic biology technology is designed to create Better DNA™ at industrial scale, enabling unprecedented control over the function and output of living cells by providing external control over in vivo activation and regulation of potent effectors. This platform, called UltraVector®, provides speed, flexibility, consistency and precision to the design, production and testing of rationally designed complex transgenes and their encoded genetic circuits. These qualities allow an iterative and rational approach to transgene design, which can be continually engineered until the host cell performance is optimized. Through this process, Intrexon is able to overcome the challenges inherent in current therapeutic strategies, including recombinant protein therapies and constitutive gene therapies, thereby enhancing capabilities, improving safety and lowering cost for human therapeutics.
"Our collaboration with Intrexon is consistent with Adeona's strategy of building shareholder value through continuous evaluation of new product opportunities and acting upon those that meet Adeona's mission of delivering disease-modifying therapies for serious illnesses. We believe that this product opportunity and collaboration far and away exceeds these criteria, and we are pleased to be working with Intrexon to make this important new therapy available to PAH patients," stated Adeona's Chairman, Jeffrey Riley.
"Current sales of approved therapies for PAH are an estimated $3 billion per year. While current therapies may improve quality of life, they have for the most part shown only modest improvements in survival, if any. We believe that by having the ability to correct what is considered to be a critical pathophysiological defect in PAH, namely reduced expression of prostaglandin synthase, we may have the opportunity to fundamentally change the course of PAH. We further believe that the 'second generation' rational nature of Intrexon's genetic engineering technology provides the enabling technology necessary to make this goal a practical reality for PAH patients. We are pleased to be working with Intrexon in this exciting and potentially disease changing collaboration," stated James S. Kuo, M.D., M.B.A., Chief Executive Officer of Adeona.
"We are very pleased to collaborate with Adeona in this further demonstration of the breadth of Intrexon's UltraVector® platform and embedded controllable bioreactor approach to novel therapeutics. We are impressed with Adeona's demonstrated ability to operate efficiently and decisively and we believe these qualities will serve both parties well as we navigate through the drug development process and commercialization," stated Glenn Nedwin, President, Human Therapeutics Division at Intrexon.
Under terms of the agreement:
Subject to the pre-approval of the NYSE Amex, Adeona will issue to Intrexon at $0.001 par value per share, 3,123,558 shares of its common stock, representing 9.995% of Adeona's issued and outstanding shares following and after taking into account such issuance; Adeona has agreed to issue to Intrexon an equal number of additional shares of its common stock at $0.001 par value per share, representing an additional 9.995%, upon dosing of the first patient in an Adeona-sponsored U.S. Phase II clinical trial of the candidate product using Intrexon technology;
Intrexon has been granted the right to purchase up to 19.99% of securities offerings that may be conducted by Adeona in the future, subject to certain conditions and limitations;
Intrexon has been granted the right to make purchases of Adeona's common stock in the open market up to an additional 10% of Adeona's common stock; and
Subject to certain expense allocations, Adeona will pay Intrexon 50% of the cumulative net quarterly profits derived from the sale of products developed from the channel collaboration.
"Because of the very wide breadth of applications that our technologies may enable, we believe that we can play a democratizing role among companies within traditional life science industries and among those in other industries that look to life science to supply solutions that their existing industrial processes have been otherwise unable to provide," stated RJ Kirk, Intrexon's Chairman and CEO. "In therapeutics, in particular, we see many opportunities for game changing strategies to be deployed against indications both large and small, complex and simple. In consequence, and as part of our business strategy, we look for opportunities to align ourselves with smaller, more entrepreneurial companies around focused opportunities that may be fully explored at costs and on timelines that previously were not available. Our new collaboration with Adeona around PAH exemplifies such an alignment and we celebrate our partner's entrepreneurial spirit, vision and dedication to the service of patients as we begin the work of producing a meaningful improvement to the lives of people with this unfortunate but theoretically treatable condition."
If the NYSE Amex approval of the issuance of the securities described above is not received within 60 days of the date of the execution of the exclusive channel agreement, Intrexon has the right to terminate the exclusive channel collaboration.
Griffin Securities served as financial advisor to Intrexon in connection with the transaction.
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension is a progressive, disabling and life-threatening disorder characterized by abnormally high blood pressure (hypertension) in the pulmonary artery, the blood vessel that carries blood from the heart to the lungs. Hypertension occurs when most of the very small arteries throughout the lungs narrow in diameter, which increases the resistance to blood flow through the lungs. To overcome the increased resistance, pressure increases in the pulmonary artery and in the heart chamber that pumps blood into the pulmonary artery (the right ventricle). Signs and symptoms of pulmonary arterial hypertension occur when increased pressure cannot fully overcome the elevated resistance and blood flow to the body is insufficient. Shortness of breath during exertion and fainting spells are the most common early symptoms of pulmonary arterial hypertension. Despite current treatments, the outcome of PAH is generally very poor and associated with high rates of mortality within three to five years of diagnosis.
About Intrexon Corporation
Intrexon Corporation is a privately held synthetic biology company that employs modular DNA control systems to enhance capabilities, improve safety and lower cost in human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The company's advanced transgene engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly and optimization. More information about the company is available at www.DNA.com.
SOURCE Adeona Pharmaceuticals, Inc.
Read more: http://www.nasdaq.com/aspx/...ary-arterial-hypertension#ixzz1eOIIO1nW
Manchmal zahlt sich Geduld aus.
Hoffe die Tendenz bleibt.Nach der Meldung könnte noch E I N I G E S drinsitzen!
@bierro auch diesmal wird es ein crash werden werden! jedoch TOI...TOI...TOI... alles gute
nur meine meinung, jeder soll sich sein eigenes bild machen
Ohne Substanz ist absoluter Quatsch!
na dann, wie sagt die merkel " ALLES WIRD GUT " ... warten wir es mal ab.
MFG
Chali
Chali, wo hast Du die ganze Zeit gesteckt, lange nix mehr gehört.
Und die alte Ostsemmel aus dem Harz hat mich bis hierhin verfolgt, lol.. So sieht ein Anstieg aus, Ostharzer, nicht wie bei Eurer PAK, die sich seit Monaten im Seitwärtstrend befindet.
Substanzlos, so so...
-- PNA Center for Neurological Research Clinical Study Results Presented at the 22nd International Symposium on ALS/Motor Neurone Disease --
ANN ARBOR, Mich., Nov. 30, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative disease-modifying medicines for serious illnesses, announced today that the Company's clinical collaborator for amyotrophic lateral sclerosis (ALS), PNA Center for Neurological Research (PNA), reported top-line results from its pilot Phase I/II open label, three month safety study of oral high dose zinc therapy in ALS, also known as Lou Gehrig's disease. The clinical study met its primary outcome as no safety issues related to zinc therapy were observed. In addition, an average decrease in the monthly rate of disease progression was observed in the ALS patients on zinc therapy, compared to published historical controls, as well as compared to the average monthly rate of disease progression of the subjects prior to enrollment in the study.
PNA's clinical study data was presented at the 22nd International Symposium on ALS/Motor Neurone Disease in Sydney, Australia on Wednesday, November 30, 2011 at 6:00 p.m. (Wednesday, November 30, 2011 at 2:00 a.m. Eastern Standard Time), by David S. Saperstein, M.D., and Nicole C. Hank, M.H.S.M., from PNA.
Ten patients diagnosed with sporadic ALS and on stable doses of RILUTEK® (riluzole) were enrolled in the open label, three month study of oral high dose zinc therapy. The study was conducted under an Investigational New Drug application (IND) and was registered at http://clinicaltrials.gov/ct2/show/NCT01259050. The rate of disease progression was measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a widely used, validated rating scale that assesses the progression of disability in patients with ALS, revised to also incorporate assessments of respiratory function. At baseline, the average ALSFRS-R score of these patients was 33 and the average time from symptom onset was one year.
Patients were administered pills containing 90mg of elemental zinc per day, as well as 2 mg of copper every other day to prevent potential copper depletion. Eight out of the ten patients enrolled completed three months of zinc therapy. Two patients dropped out within the first month for reasons unrelated to the zinc therapy. All patients reported taste disturbance (metallic taste) and two of eight patients reported nausea (both of whom were able to complete the study after reducing their dose to 60mg of zinc per day).
On average, the eight patients who completed the study lost 0.37 ALSFRS-R points per month during the three months of therapy. This represents a lower rate of monthly disease progression compared to the average 0.89 ALSFRS-R monthly rate of disease progression in ALS based on historical controls.[i] Prior to enrolling in the study, seven of the eight patients for whom previous ALSFRS-R scores were available lost an average of 0.61 ALSFRS-R points per month.
Based on these findings, the neurologists at PNA hypothesize that high doses of zinc may slow disease progress in ALS and that a larger controlled clinical trial of zinc therapy in ALS patients is warranted. Preparations are currently underway to evaluate the safety and efficacy of Adeona's proprietary drug candidate, AEN-100, a gastroretentive, sustained-release, zinc tablet, in an adaptively designed, multi-center, double-blind, placebo-controlled Phase II/III clinical trial in ALS patients to be conducted under an IND. It is anticipated that the trial will enroll approximately 65 ALS patients, who will continue on RILUTEK® (riluzole) as the standard of care treatment, and that the patients will be randomized into two treatment groups and one matching placebo group. They will receive clinical trial medications for at least six months with periodic monitoring. A small Phase I pharmacokinetic clinical trial of AEN-100 is planned for completion prior to initiating the multi-center clinical trial. It is anticipated that Adeona will provide the study medications and fund the clinical trials, which will be led by the neurology team at PNA.
"We are pleased to report that the use of zinc is safe in ALS patients, and we are also encouraged to observe that this small group of ALS patients demonstrated a reduced rate of change in their ALSFRS-R scores while taking zinc, suggesting a slower rate of disease progression," said Todd D. Levine, M.D., President of PNA, Assistant Clinical Professor at the University of Arizona, Co-Director of the Banner Samaritan ALS Center in Phoenix, Arizona and Lead Principal Investigator of Adeona's planned clinical trial. "We look forward to initiating this larger clinical trial in ALS patients and to providing Adeona's proprietary zinc-based therapy that has already demonstrated clinical evidence of being very well tolerated by patients and of providing superior bioavailability."
"Given the clinical results PNA presented today at an international symposium suggesting a safe and therapeutic role for zinc in ALS, we believe it supports our planned Phase II/III clinical trial of AEN-100 in ALS patients," said James S. Kuo, M.D., M.B.A., Chief Executive Officer of Adeona. "We are pleased to be working with the dedicated neurologists at PNA to evaluate the potentially revolutionary therapeutic benefit of AEN-100 for this devastating and fatal progressive neurological disease."
About AEN-100
AEN-100 is Adeona's patent-pending gastroretentive, sustained-release oral zinc drug candidate intended for indications in which high dose zinc therapy may be appropriate. Based upon prior studies conducted by Adeona, the Company believes that AEN-100 provides far superior gastrointestinal tolerability and once-daily dosing convenience compared to existing zinc therapy products. Gastrointestinal tolerability (namely, nausea and vomiting) represents a major dose limiting factor of oral high dose zinc therapy. Adeona also intends to file for orphan drug protection with the Food & Drug Administration (FDA) in the U.S. and European Medicines Agency (EMEA) in the E.U, which may provide for marketing exclusivity for a period of seven and ten years, respectively, following approval. In ALS, there is a demonstrated zinc binding defect of the ALS-implicated protein known as copper/zinc superoxide dismutase (SOD-1) as well as a demonstrated sequestration of zinc in the Lewy body-like hyaline inclusions that are characteristic of ALS.[ii]
About Amyotrophic Lateral Sclerosis (ALS)
ALS is a devastating progressive neurodegenerative disease that affects the motor nerve cells in the brain and the spinal cord of predominantly older people of both sexes. It is estimated that as many as 30,000 Americans may have the disease at any given time. The progressive degeneration of the motor neurons in ALS eventually leads to the death of the patient. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. When motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.
While non-invasive ventilation and gastrostomy tubes prolong life by 6-12 months, the average lifespan from time of symptom onset is 2-5 years. Currently, RILUTEK is the only FDA-approved drug for ALS. RILUTEK is an NMDA receptor antagonist and has been shown to prolong life in patients with ALS by 3 months. Presently, there is no cure for ALS, nor is there a known cause. For more information on ALS, please visit the ALS Association website at www.alsa.org.
About PNA Center for Neurological Research
PNA Center for Neurological Research (PNA) is an independent, not-for-profit organization based in Phoenix, Arizona. PNA was established by five of the neurologists from Phoenix Neurological Associates, Ltd., who are dedicated to discovering new treatments for patients with neurological diseases. PNA's goal is to be a hub where philanthropists, advocates, organizations, family and friends of patients with a neurological illness could make donations that can support investigator-initiated clinical trials. PNA hopes to optimize proper treatments in order to improve outcomes for patients with neurological diseases. For more information about PNA, please visit its website at www.pnaresearch.org. For more information about Phoenix Neurological Associates, Ltd., please visit its website at www.phoenixneurology.com.
SOURCE Adeona Pharmaceuticals, Inc.
Read more: http://www.nasdaq.com/aspx/...zinc-for-als-collaborator#ixzz1fIkhdI4K
(RTTNews) - Adeona Pharmaceuticals, Inc. (AEN) Wednesday said PNA Center for Neurological Research's pilot Zinc Therapy was found to be safe and recorded a slow disease progression in amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig's Disease.
The study was conducted under an Investigational New Drug or IND application and Adeona plans to begin a Phase II/III clinical trial of its zinc tablet AEN-100, and to file for orphan drug protection.
ALS is a devastating progressive neurodegenerative disease that affects the motor nerve cells in the brain and the spinal cord of predominantly older people of both sexes. It is estimated that as many as 30,000 Americans may have the disease at any given time. When motor neurons die, the ability of the brain to initiate and control muscle movement is lost. Patients in the later stages of the disease may become totally paralyzed.
According to Adeona, the average lifespan from time of symptom onset is 2 to 5 years. Rilutek is the only FDA-approved drug for ALS, prolonging life by 3 months. The pilot study enrolled ten patients diagnosed with sporadic ALS and on stable doses of Rilutek or riluzole. Eight out of the ten completed three months of zinc therapy.
Patients were administered pills containing 90 mg of elemental zinc per day, as well as 2 mg of copper every other day to prevent potential copper depletion. The rate of disease progression was measured by the ALS Functional Rating Scale-Revised or ALSFRS-R, that incorporates assessments of respiratory function. At baseline, the average ALSFRS-R score of these patients was 33 and the average time from symptom onset was one year.
At three months, the eight patients who completed the study lost on average, 0.37 ALSFRS-R points per month during the three months of therapy. This represented a lower rate of monthly disease progression compared to historical controls, which had demonstrated a average 0.89 ALSFRS-R monthly rate of disease progression.
Adeona is preparing to evaluate the safety and efficacy of its proprietary drug candidate, AEN-100, a gastroretentive, sustained-release, zinc tablet, in an adaptively designed, multi-center, double-blind, placebo-controlled Phase II/III clinical trial.
PNA's clinical study data was presented today at the 22nd International Symposium on ALS/Motor Neurone Disease in Sydney, Australia.
AEN is currently trading at $1.08, up $0.25 or 30.12%, on a volume of 1.7 million shares, on the AMEX. Over the past year, the stock traded in a range of $0.42 - $2.25.
For comments and feedback: contact editorial@rttnews.com
Read more: http://www.nasdaq.com/aspx/...al-in-lou-gehrigs-disease#ixzz1fInGWuu3
MFG
Chali
P.S. Hi bierro ,altes Haus,was ist mal wieder mit YRCW los..... ,hahaha ?
Wir stehen heute bereits bei 1,15 USD.
Wahnsinn!
MFG
Chali
Heute schon mal im Hoch bis 1,41.Das deutet die Richtung an.
Momentan 20% plus!
Mit Gewinnmitnahmen wird man in Zukunft immer mal rechnen müssen,aber Haupsache die Richtung bleibt.
Gebt es Meinungen ? Die aktie ein Kauf ?!!
MFG
Chali
MFG
Chali
Sind sicherlich etwas unberechtigt abgestraft worden auch i.Z. mit dem Dendreon Verfall im August.Für 3,60 sind sie m.M. nach erst mal gut.Dann mal schauen.
Charttechnisch auch sehr gut.