ACCP.OB ...Das Geld liegt auf der Straße lol - 500 Beiträge pro Seite
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Im unteren Artikel findet ihr alles was ihr wissen müsst .
Access ist wohl die nächste Vanda
Access Pharma (ACCP.OB)
MarktKap : 33 Mio US$
Kurs : 1,50 $
Shares Out : 22 Mio Aktien
7 May 2009
With shares of Cell Therapeutics (NASDAQ:CTIC) staging the most astonishing comeback I have ever witnessed while rising from 8 cents at the time of my original article in early February to as high as $1.85 during intraday trading today and closing at $1.27 – I went in search of another out-of-favor name in the cancer biotech space.
Access Pharma (ACCP.OB) is an emerging bio-pharma company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to an FDA approved treatment for a side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining). Valued at roughly $30M, ACCP has multiple shots at goal in its clinical pipeline in addition to a reduced risk profile because the compounds in development are improved versions of existing drugs with established mechanisms of action.
The company has completed six partnerships within the past 18 months with more expected to follow as ACCP seeks to mitigate the inherent risk of the clinical development process. ACCP has assembled a diverse and experienced team of executives and consultants while insiders own a significant (50%) stake to ensure their interests are aligned with shareholders.
MuGard is the company's FDA-approved product which functions like a liquid Band-Aid to protect the lining of the oral cavity in cancer patients who develop mucositis as a side effect of radiation or chemotherapy. By 3Q09, the product will be launched in all major global markets with estimated peak sales of $350M (based on marketing partner estimates) and a scaled royalty rate of 20-25% (i.e. over $70M royalties on peak sales which is over 2X the current market cap).
A very promising, next-generation platinum anti-cancer compound in the company's pipeline is known as ProLindac, which includes a proprietary nano-polymer delivery vehicle that allows for over 10X the dose of platinum to be delivered to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity. The unique nano-polymer delivery system selectively releases the platinum in a targeted manner to cancer cells, which reside at a low pH (acidic).
ProLindac is meant to be a safer, more effective replacement for Eloxatin (oxaliplatin), which posted estimated global sales of $2.5B in 2008 for Sanofi-Aventis (NYSE:SNY). In addition to having more side effects than ProLindac, Eloxatin is available on an off-patent basis in Europe. ACCP also employs Esteban Cvitkovic as their director of oncology R&D – who has over 30 years of experience in this area and played a key role at SNY in the development and approval of Eloxatin.
Preliminary data from a Phase 2 clinical trial in patients with relapsed ovarian cancer demonstrated that over 12X the dose of ProLindac was delivered compared to Eloxatin and the final data from this trial is still pending. Despite the much larger platinum dose delivered by ProLindac, the drug demonstrated an excellent safety profile in the trial among patients receiving nine or more cycles of therapy.
Thiarabine is the company's next-generation nucleoside analogue (e.g. fludarabine, cladrabine) designed for the treatment of blood-based cancers such as lymphoma and leukemia. Once again, ACCP is working with the leader in this field – in this case, Dr. Hagop Kantarjian, who is Head of the Leukemia Department at the M.D. Anderson Cancer Center in Houston (which is the primary treatment centre in the U.S. for leukaemia and lymphoma). The company is currently finalizing clinical trial protocols based on previously gathered data to evaluate the drug in a variety of leukaemia and lymphoma subtypes.
ACCP also has a monoclonal antibody (MAb) with encouraging preclinical results in comparison to Roche's (RHHBY.PK) Avastin. Angiolix targets a specific portion of a protein called lactadherin that is only expressed on solid tumors. Angiolix has a dual mechanism of action, which includes (1) inhibiting angiogenesis (blood vessel proliferation which feeds tumor growth) via the lactadherin target and (2) inducing a process known as apoptosis or programmed cell death in cancer cells which are dividing and growing in an unregulated manner. Unlike Avastin, Angiolix has an anti-proliferative effect on cancer cells when used by itself in addition to when it is used in combination with other chemo drugs.
The company also offers a nano-polymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO). This novel delivery mechanism utilizes the body's vitamin B12 absorption system in a Trojan Horse manner with the potential to eliminate the need for injections.
The technology involves coating a nano-particle with a B12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package and its contents of large molecule drugs not normally available by oral administration (e.g. insulin, hGH, EPO). This process increases the cellular uptake in the gut of such large molecule drugs by a factor of 1,000X to 1,000,000X.
ACCP anticipates an expense of $2M and about 12-15 months to get an IND filed to initiate clinical trials in humans; although this timeline could be shortened if such trials were conducted outside of the U.S. A long-acting, basal insulin product (similar to Lantus) is the most advanced in terms of achieving oral bioavailability of 80-90% after initially achieving results in the 30-40% range. hGH, which is about 3X larger than insulin on a molecular basis, is currently in the 30-40% bioavailability range in preclinical animal models.
The company has about 22M total shares of common stock, including 11.3M shares outstanding and 10.6M shares of common stock under preferred shares – please note the financial data providers such as Yahoo and Google Finance only include the 11.3M shares in their calculations of market cap and other metrics. ACCP has a $5.5M note due at the end of 2011, which is convertible at a price of $27.50 per share.
ACCP projects that it will have sufficient liquidity into 2010 based on its current cash/equivalents ($2.7M at year-end) and expected upfront, royalty, and milestone payments. During 2H09, the company plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail, Pexiganan).
The final Phase 2 ovarian cancer trial results are also pending and ACCP is engaged in ongoing discussions for either regional or a global partnership deal for the drug in addition to initiating Phase 2 studies of the drug in combination with other chemo drugs (paclitaxel, gemcitabine). ACCP is seeking to transition from OTC to re-list on a national exchange such as Nasdaq in order to increase its visibility and liquidity for investors.
Given a very low cash burn rate of about $4M per year, a diverse/late-stage pipeline, extensive partnership agreement, and the pending global commercialization of MuGard by 3Q09 with a 20-25% royalty rate, the current market valuation of around $30M does not appear to fully account for both the breadth and depth of the pipeline in addition to the large commercial markets the compounds are designed to serve. If MuGard reaches just $20M in global sales at a 20% royalty rate, this alone would cover the current low rate of cash burn itself.
Access ist wohl die nächste Vanda
Access Pharma (ACCP.OB)
MarktKap : 33 Mio US$
Kurs : 1,50 $
Shares Out : 22 Mio Aktien
7 May 2009
With shares of Cell Therapeutics (NASDAQ:CTIC) staging the most astonishing comeback I have ever witnessed while rising from 8 cents at the time of my original article in early February to as high as $1.85 during intraday trading today and closing at $1.27 – I went in search of another out-of-favor name in the cancer biotech space.
Access Pharma (ACCP.OB) is an emerging bio-pharma company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to an FDA approved treatment for a side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining). Valued at roughly $30M, ACCP has multiple shots at goal in its clinical pipeline in addition to a reduced risk profile because the compounds in development are improved versions of existing drugs with established mechanisms of action.
The company has completed six partnerships within the past 18 months with more expected to follow as ACCP seeks to mitigate the inherent risk of the clinical development process. ACCP has assembled a diverse and experienced team of executives and consultants while insiders own a significant (50%) stake to ensure their interests are aligned with shareholders.
MuGard is the company's FDA-approved product which functions like a liquid Band-Aid to protect the lining of the oral cavity in cancer patients who develop mucositis as a side effect of radiation or chemotherapy. By 3Q09, the product will be launched in all major global markets with estimated peak sales of $350M (based on marketing partner estimates) and a scaled royalty rate of 20-25% (i.e. over $70M royalties on peak sales which is over 2X the current market cap).
A very promising, next-generation platinum anti-cancer compound in the company's pipeline is known as ProLindac, which includes a proprietary nano-polymer delivery vehicle that allows for over 10X the dose of platinum to be delivered to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity. The unique nano-polymer delivery system selectively releases the platinum in a targeted manner to cancer cells, which reside at a low pH (acidic).
ProLindac is meant to be a safer, more effective replacement for Eloxatin (oxaliplatin), which posted estimated global sales of $2.5B in 2008 for Sanofi-Aventis (NYSE:SNY). In addition to having more side effects than ProLindac, Eloxatin is available on an off-patent basis in Europe. ACCP also employs Esteban Cvitkovic as their director of oncology R&D – who has over 30 years of experience in this area and played a key role at SNY in the development and approval of Eloxatin.
Preliminary data from a Phase 2 clinical trial in patients with relapsed ovarian cancer demonstrated that over 12X the dose of ProLindac was delivered compared to Eloxatin and the final data from this trial is still pending. Despite the much larger platinum dose delivered by ProLindac, the drug demonstrated an excellent safety profile in the trial among patients receiving nine or more cycles of therapy.
Thiarabine is the company's next-generation nucleoside analogue (e.g. fludarabine, cladrabine) designed for the treatment of blood-based cancers such as lymphoma and leukemia. Once again, ACCP is working with the leader in this field – in this case, Dr. Hagop Kantarjian, who is Head of the Leukemia Department at the M.D. Anderson Cancer Center in Houston (which is the primary treatment centre in the U.S. for leukaemia and lymphoma). The company is currently finalizing clinical trial protocols based on previously gathered data to evaluate the drug in a variety of leukaemia and lymphoma subtypes.
ACCP also has a monoclonal antibody (MAb) with encouraging preclinical results in comparison to Roche's (RHHBY.PK) Avastin. Angiolix targets a specific portion of a protein called lactadherin that is only expressed on solid tumors. Angiolix has a dual mechanism of action, which includes (1) inhibiting angiogenesis (blood vessel proliferation which feeds tumor growth) via the lactadherin target and (2) inducing a process known as apoptosis or programmed cell death in cancer cells which are dividing and growing in an unregulated manner. Unlike Avastin, Angiolix has an anti-proliferative effect on cancer cells when used by itself in addition to when it is used in combination with other chemo drugs.
The company also offers a nano-polymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO). This novel delivery mechanism utilizes the body's vitamin B12 absorption system in a Trojan Horse manner with the potential to eliminate the need for injections.
The technology involves coating a nano-particle with a B12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package and its contents of large molecule drugs not normally available by oral administration (e.g. insulin, hGH, EPO). This process increases the cellular uptake in the gut of such large molecule drugs by a factor of 1,000X to 1,000,000X.
ACCP anticipates an expense of $2M and about 12-15 months to get an IND filed to initiate clinical trials in humans; although this timeline could be shortened if such trials were conducted outside of the U.S. A long-acting, basal insulin product (similar to Lantus) is the most advanced in terms of achieving oral bioavailability of 80-90% after initially achieving results in the 30-40% range. hGH, which is about 3X larger than insulin on a molecular basis, is currently in the 30-40% bioavailability range in preclinical animal models.
The company has about 22M total shares of common stock, including 11.3M shares outstanding and 10.6M shares of common stock under preferred shares – please note the financial data providers such as Yahoo and Google Finance only include the 11.3M shares in their calculations of market cap and other metrics. ACCP has a $5.5M note due at the end of 2011, which is convertible at a price of $27.50 per share.
ACCP projects that it will have sufficient liquidity into 2010 based on its current cash/equivalents ($2.7M at year-end) and expected upfront, royalty, and milestone payments. During 2H09, the company plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail, Pexiganan).
The final Phase 2 ovarian cancer trial results are also pending and ACCP is engaged in ongoing discussions for either regional or a global partnership deal for the drug in addition to initiating Phase 2 studies of the drug in combination with other chemo drugs (paclitaxel, gemcitabine). ACCP is seeking to transition from OTC to re-list on a national exchange such as Nasdaq in order to increase its visibility and liquidity for investors.
Given a very low cash burn rate of about $4M per year, a diverse/late-stage pipeline, extensive partnership agreement, and the pending global commercialization of MuGard by 3Q09 with a 20-25% royalty rate, the current market valuation of around $30M does not appear to fully account for both the breadth and depth of the pipeline in addition to the large commercial markets the compounds are designed to serve. If MuGard reaches just $20M in global sales at a 20% royalty rate, this alone would cover the current low rate of cash burn itself.
Access Pharmaceuticals Announces the European Launch of MuGard(TM) by its European Partner, SpePharm
DALLAS, April 22 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), announced today that MuGard(TM), its proprietary polymer-based oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care.
Under a license from Access Pharmaceuticals Inc, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. In October 2008, MuGard was granted CE Mark certification by the Dutch Notified Body (KEMA). SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. Access will receive significant royalties on net sales.
"SpePharm and Access are pleased with the commercial launch of MuGard in Europe, and while it is still in the early days, initial feedback has been positive," said Phillip Wise, Vice President of Business Development at Access. "SpePharm is also working hard to secure reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option. We look forward to further commercial launches from our other MuGard commercialization partners," he continued.
MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
DALLAS, April 22 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), announced today that MuGard(TM), its proprietary polymer-based oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care.
Under a license from Access Pharmaceuticals Inc, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. In October 2008, MuGard was granted CE Mark certification by the Dutch Notified Body (KEMA). SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. Access will receive significant royalties on net sales.
"SpePharm and Access are pleased with the commercial launch of MuGard in Europe, and while it is still in the early days, initial feedback has been positive," said Phillip Wise, Vice President of Business Development at Access. "SpePharm is also working hard to secure reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option. We look forward to further commercial launches from our other MuGard commercialization partners," he continued.
MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
14 US$ Kursziel hmm ich wäre schon mit der hälfte zufrieden
Griffin Securities, Inc. Announces Investment Opinion on Access Pharmaceuticals, Inc. (StreetInsider.com News Articles) - Nov 12, 2008
Access Pharmaceuticals, Inc. (ACCP) - Chrystyna Bedrij at Griffin Securities
Griffin Securities, Inc updates research coverage on Access Pharmaceuticals, Inc (OTCBB: ACCP ) with a buy Rating and a 12-month price target of $14. Chrystyna Bedrij, Director of Research, issued the report. Griffin Securities, Inc specializes in identifying small cap emerging growth investment opportunities.
Chrystyna Bedrij
Griffin Securities, Inc. Announces Investment Opinion on Access Pharmaceuticals, Inc. (StreetInsider.com News Articles) - Nov 12, 2008
Access Pharmaceuticals, Inc. (ACCP) - Chrystyna Bedrij at Griffin Securities
Griffin Securities, Inc updates research coverage on Access Pharmaceuticals, Inc (OTCBB: ACCP ) with a buy Rating and a 12-month price target of $14. Chrystyna Bedrij, Director of Research, issued the report. Griffin Securities, Inc specializes in identifying small cap emerging growth investment opportunities.
Chrystyna Bedrij
Ein guter Tipp mit einer interessanten Pipeline
Trading Spotlight
Es geht aufwärts um diese Aktie werde ich mich in den nächsten Tagen kümmern
Hier habe ich leider nur wenige Anteile obwohl ACCP wirklich Potential hat ..
Hier habe ich leider nur wenige Anteile obwohl ACCP wirklich Potential hat ..
Nächste Woche kümmere ich mich um diese hübsche Aktie ....
Noch bewegt sich Accp unterm Radar !
Access Pharmaceuticals Provides Update on Global Launch of MuGard(TM)
* On Wednesday May 27, 2009, 8:30 am EDT
* Access Pharmaceuticals Inc.
NEW FDA-APPROVED TREATMENT FOR ORAL MUCOSITIS
DALLAS, May 27 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), (http://www.accesspharma.com) announced today that MuGard(TM), its proprietary oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care. The Company has previously announced commercialization agreements in North America, China and eight Southeast Asian countries and Korea, and is actively seeking additional marketing partners in other regions; MuGard expects commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement gets established regionally.
MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiation therapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
"Access is pleased with the commercial launch of MuGard in Europe, and the progress made by our partners in other regions of the world," said Phillip Wise, Vice President of Business Development at Access. "Access is also working with its partners outside of Europe to establish GMP manufacturing and secure necessary approvals and/or reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option," he continued.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
Noch bewegt sich Accp unterm Radar !
Access Pharmaceuticals Provides Update on Global Launch of MuGard(TM)
* On Wednesday May 27, 2009, 8:30 am EDT
* Access Pharmaceuticals Inc.
NEW FDA-APPROVED TREATMENT FOR ORAL MUCOSITIS
DALLAS, May 27 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), (http://www.accesspharma.com) announced today that MuGard(TM), its proprietary oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care. The Company has previously announced commercialization agreements in North America, China and eight Southeast Asian countries and Korea, and is actively seeking additional marketing partners in other regions; MuGard expects commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement gets established regionally.
MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiation therapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
"Access is pleased with the commercial launch of MuGard in Europe, and the progress made by our partners in other regions of the world," said Phillip Wise, Vice President of Business Development at Access. "Access is also working with its partners outside of Europe to establish GMP manufacturing and secure necessary approvals and/or reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option," he continued.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
strong buy
Antwort auf Beitrag Nr.: 37.277.422 von [KERN]Codex am 28.05.09 22:52:30Nicht nur strong buy sondern strong buy aggressive 
Nächste Woche werden wir höhere kurse sehen habs irgendwie im urin !!!
Nächste Woche werden wir höhere kurse sehen habs irgendwie im urin !!!
Die gelegenheit unter 2$ zu kaufen ist bald vorbei !!!
Und wieder tolle News von ACCP !!!!
Access Pharmaceuticals Provides Update on ProLindac(TM) Phase 2 Ovarian Cancer Trial and Clinical Development Plan
* On Monday June 1, 2009, 9:00 am EDT
ProLindac Showing High DACH Platinum Activity; Drug Well Tolerated With No Signs of Acute Neurotoxicity
DALLAS, June 1 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (http://www.accesspharma.com) (OTC Bulletin Board: ACCP - News), provided an update today on the progress in the Company's clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. Access recently announced positive safety and efficacy results from its Phase 2 monotherapy clinical study of ProLindac(TM) in late-stage, heavily pretreated ovarian cancer patients. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall. The Company has scaled up manufacturing in order to begin the next phase of clinical development. Access plans to conduct several combination trials in different solid tumor types both as Company-sponsored trials and in conjunction with its two previously announced co-development partners.
"Access is extremely pleased with the clinical results to date, which we believe reflect that we have a significant DACH platinum drug candidate with a safety profile superior to commercially available platinum therapies," stated Jeffrey Davis, President & CEO. "Our partners in the Far East, both Aosaikang Medicinal Group (ASK) in Nanjing, China and JCOM, in Seoul, Korea, are making great progress on manufacturing scale-up and in putting the regulatory process in place, and we are working with them diligently on the design and future management of their clinical trials. Access is in discussion with a number of potential North American and European partners for co-development of ProLindac, and to assist in marketing, when approved."
"We are very pleased with the ProLindac trial results to date which has been in over 50 patients in two trials; we saw significant DACH platinum activity and efficacy in patients at the highest dose levels which is very encouraging given that this study involved monotherapy in a heavily pretreated patient population that typically only respond to an aggressive drug combination," commented Dr. David Nowotnik, Access' Senior Vice President R&D.
The recent Phase 2 study explored three different dose levels and two dosing regimens of ProLindac as a monotherapy treatment for advanced ovarian cancer, to provide data on the monotherapy anticancer activity and safety of ProLindac. Of patients eligible for evaluation according to standard RECIST criteria, clinically-meaningful disease stabilization was achieved in 42% of all patients, and 66% of all patients in the higher dose groups. Sustained and significant reductions in Ca-125, the established specific serum marker for ovarian cancer, were also observed in several patients.
Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories.
Access Pharmaceuticals Provides Update on ProLindac(TM) Phase 2 Ovarian Cancer Trial and Clinical Development Plan
* On Monday June 1, 2009, 9:00 am EDT
ProLindac Showing High DACH Platinum Activity; Drug Well Tolerated With No Signs of Acute Neurotoxicity
DALLAS, June 1 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (http://www.accesspharma.com) (OTC Bulletin Board: ACCP - News), provided an update today on the progress in the Company's clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. Access recently announced positive safety and efficacy results from its Phase 2 monotherapy clinical study of ProLindac(TM) in late-stage, heavily pretreated ovarian cancer patients. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall. The Company has scaled up manufacturing in order to begin the next phase of clinical development. Access plans to conduct several combination trials in different solid tumor types both as Company-sponsored trials and in conjunction with its two previously announced co-development partners.
"Access is extremely pleased with the clinical results to date, which we believe reflect that we have a significant DACH platinum drug candidate with a safety profile superior to commercially available platinum therapies," stated Jeffrey Davis, President & CEO. "Our partners in the Far East, both Aosaikang Medicinal Group (ASK) in Nanjing, China and JCOM, in Seoul, Korea, are making great progress on manufacturing scale-up and in putting the regulatory process in place, and we are working with them diligently on the design and future management of their clinical trials. Access is in discussion with a number of potential North American and European partners for co-development of ProLindac, and to assist in marketing, when approved."
"We are very pleased with the ProLindac trial results to date which has been in over 50 patients in two trials; we saw significant DACH platinum activity and efficacy in patients at the highest dose levels which is very encouraging given that this study involved monotherapy in a heavily pretreated patient population that typically only respond to an aggressive drug combination," commented Dr. David Nowotnik, Access' Senior Vice President R&D.
The recent Phase 2 study explored three different dose levels and two dosing regimens of ProLindac as a monotherapy treatment for advanced ovarian cancer, to provide data on the monotherapy anticancer activity and safety of ProLindac. Of patients eligible for evaluation according to standard RECIST criteria, clinically-meaningful disease stabilization was achieved in 42% of all patients, and 66% of all patients in the higher dose groups. Sustained and significant reductions in Ca-125, the established specific serum marker for ovarian cancer, were also observed in several patients.
Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories.
Antwort auf Beitrag Nr.: 37.295.654 von BrauchGeld am 01.06.09 15:07:42Hab doch gesagt das es nächste Woche abgeht ....
Auf auf und davon ich sehe den fairen wert im bereich von 10$ !!
ich sehe den fairen wert im bereich von 10$ !!
Antwort auf Beitrag Nr.: 37.298.590 von BrauchGeld am 01.06.09 21:54:57ACCP ist eine verdammt heiße Aktie und die bewegt sich immer noch unterm Radar !!
Cashburn beträgt für diese Perle gerade mal rund 4 Mio$ pro Jahr !!!!!!
Cashburn beträgt für diese Perle gerade mal rund 4 Mio$ pro Jahr !!!!!!
Hält sich super über 2$ und die Aktie bewegt sich weiterhin unterm Radar !
Access Pharmaceuticals Announces Granting of Two US Patents for MuGard(TM)
* On Wednesday June 10, 2009, 9:00 am EDT
DALLAS, June 10 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), announced today that the Company has received issue notifications from the United States Patent and Trademark Office that two US patents relating to MuGard(TM), the Company's approved oral rinse product for the management of mucositis will issue in June as US Patent numbers 7,544,348 and 7,547,433. MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments (for more information, please see http://www.slideshare.net/accesspharma/mugard-for-oral-mucos…
For latest information on the Company and its products, please follow Access on Facebook and Twitter.
Access has announced that MuGard(TM) was launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm. Under a license from Access Pharmaceuticals Inc, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. The license agreement includes royalties on net sales to Access.
"SpePharm and Access are pleased with the commercial launch of MuGard in Europe, and while it is still in the early days, initial feedback has been positive," said Phillip Wise, Vice President of Business Development at Access. "SpePharm is working hard to secure reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option.," he continued.
MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
Access Pharmaceuticals Announces Granting of Two US Patents for MuGard(TM)
* On Wednesday June 10, 2009, 9:00 am EDT
DALLAS, June 10 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), announced today that the Company has received issue notifications from the United States Patent and Trademark Office that two US patents relating to MuGard(TM), the Company's approved oral rinse product for the management of mucositis will issue in June as US Patent numbers 7,544,348 and 7,547,433. MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments (for more information, please see http://www.slideshare.net/accesspharma/mugard-for-oral-mucos…
For latest information on the Company and its products, please follow Access on Facebook and Twitter.
Access has announced that MuGard(TM) was launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm. Under a license from Access Pharmaceuticals Inc, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. The license agreement includes royalties on net sales to Access.
"SpePharm and Access are pleased with the commercial launch of MuGard in Europe, and while it is still in the early days, initial feedback has been positive," said Phillip Wise, Vice President of Business Development at Access. "SpePharm is working hard to secure reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option.," he continued.
MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
We are updating coverage on Access Pharmaceuticals, Inc. (OTCBB: ACCP) with a BUY rating and a 12-month price target of $7.50 for ACCP shares.
http://www.stockshaven.com/wp-content/themes/Cleaker2.1%20wi…
Wer Zeit und Lust hat kann sich diese gute Analyse von Griffin durchlesen !
http://www.stockshaven.com/wp-content/themes/Cleaker2.1%20wi…
Wer Zeit und Lust hat kann sich diese gute Analyse von Griffin durchlesen !
MuGard jetzt auch in Griechenland erhältlich !
Access Pharmaceuticals Announces Commercial Launch of MuGard(TM) in Greece by SpePharm
* Press Release
* Source: Access Pharmaceuticals, Inc.
* On Monday June 29, 2009, 11:13 am EDT
Companies: o Access pharmaceuticals inc.
Two MuGard US Patents Issued
DALLAS, June 29 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), announced today that its European partner, SpePharm has commenced commercial launch of MuGard in Greece. This follows previous commercial launches in Germany, Italy and the UK. Under a license from Access Pharmaceuticals, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. The license agreement includes royalties on net sales to Access.
Additionally, the Company announced that two MuGard(TM) patents have been issued from the United States Patent and Trademark Office, as US Patent numbers 7,544,348 and 7,547,433. The second patent includes claims on formulations with actives against mucocutaneous disorders, which provides protection of product line extensions.
MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
Access Pharmaceuticals Announces Commercial Launch of MuGard(TM) in Greece by SpePharm
* Press Release
* Source: Access Pharmaceuticals, Inc.
* On Monday June 29, 2009, 11:13 am EDT
Companies: o Access pharmaceuticals inc.
Two MuGard US Patents Issued
DALLAS, June 29 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), announced today that its European partner, SpePharm has commenced commercial launch of MuGard in Greece. This follows previous commercial launches in Germany, Italy and the UK. Under a license from Access Pharmaceuticals, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. The license agreement includes royalties on net sales to Access.
Additionally, the Company announced that two MuGard(TM) patents have been issued from the United States Patent and Trademark Office, as US Patent numbers 7,544,348 and 7,547,433. The second patent includes claims on formulations with actives against mucocutaneous disorders, which provides protection of product line extensions.
MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
Antwort auf Beitrag Nr.: 37.487.420 von BrauchGeld am 29.06.09 17:18:09Moin
Danke für Deine Tips
gruss Macos
Danke für Deine Tips
gruss Macos
http://www.mffais.com/accp.obwo ham se die alle herbekommen, übern Markt wohl nicht???
der war glaube ich noch nicht?DALLAS, TX, June 17, 2009, ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced today that the Company has signed evaluation agreements with two biopharmaceutical companies for its Cobalamin™ Oral Drug Delivery Technology . Under the terms of the agreements, both companies plan to evaluate Access' Oral Insulin product in preclinical models as a prerequisite to entering licensing discussions. Access announced previously that it had an agreement with a large pharmaceutical company for the evaluation of Cobalamin oral drug delivery formulations of human growth hormone (hGH) .
“While all of the products and technologies which we chose to showcase at the recent BIO 2009 conference in Atlanta attracted a great deal of interest, it was clear that the Cobalamin oral drug delivery technology generated the most interest” commented Phillip Wise, Access' Vice President of Business Development and Strategy. “We are delighted that two companies have decided to take a closer look at the Cobalamin Oral Drug Delivery Technology. Meanwhile, we have several ongoing discussions with other companies regarding the application of our oral drug delivery options for their promising new drugs.”
The proprietary Cobalamin™ technology utilizes the body's natural vitamin B12 oral uptake mechanism to facilitate oral absorption of pharmaceuticals by a “Trojan horse” mechanism. Since presenting promising results at a scientific conference in mid-2008, Access has made substantial improvements to the formulation technology. A new Cobalamin-coated insulin-containing nanoparticle formulation delivered orally provided a pharmacological response (lowering of blood glucose levels in an animal model of diabetes) equivalent to 90% of that achieved by insulin delivered subcutaneously. This represents a substantial oral bioavailability, indicating that this formulation has potential for clinical development and ultimate commercialization. Adaptation of this technology has provided a Cobalamin human growth hormone formulation that has demonstrated good efficacy, represented by more than 25% improvement in weight gain, when given orally in an established animal model. Access continues to move both products towards clinical development, and plans to submit an additional patent application to protect the improvements to the technology
“While Access' focus has been on the oral delivery of peptides, the technology is sufficiently flexible to allow us to deliver a wide range of actives,” commented David P. Nowotnik, Ph.D, Access' Senior Vice President of R&D. “In addition to peptide delivery, we have received inquiries recently about the potential of this technology to deliver actives ranging from small molecules to siRNA to monoclonal antibodies . As siRNA needs to be delivered intracellularly to be effective as a therapeutic, the Cobalamin technology may be particularly beneficial as an intracellular delivery technology, as the demand for vitamin B12 increases in many disease states
Moin@BrauchGeld
Hast Du dir schon mal Milestones Biotech angeschaut, den Partner für MuGard in Nordamerika!
http://milestonebio.com/
Ob die Mugard am Markt unterbringen können wage ich zu bezweifeln!
Gruss macos
Moin
Hier ist eine Presentation von Acces
http://www.slideshare.net/accesspharma/access-pharmaceutical…
Hier ist eine Presentation von Acces
http://www.slideshare.net/accesspharma/access-pharmaceutical…
MuGard: Prevention erweitert das Potential enorm
http://finance.yahoo.com/news/MuGard-Data-From-UK-Study-prne…
Gruss macos
http://finance.yahoo.com/news/MuGard-Data-From-UK-Study-prne…
Gruss macos
Und aufwärts gehts ....
Bin raus will woanders rein , ACCP bleibt weiterhin sehr interessant ..
Antwort auf Beitrag Nr.: 37.642.646 von BrauchGeld am 24.07.09 17:38:11moin
gibt es zur Zeit was aussichtsreicheres
gibt es zur Zeit was aussichtsreicheres
stellt euch mal in Diesem Tool den 5 Jahreschart ein und schaut euch den money Flow sowie den OBV an
http://bigcharts.marketwatch.com/interchart/interchart.asp?s…
Wenn mugard der renner wird gehts noch um einiges höher?
Gruss Macos
http://bigcharts.marketwatch.com/interchart/interchart.asp?s…
Wenn mugard der renner wird gehts noch um einiges höher?
Gruss Macos
Antwort auf Beitrag Nr.: 37.645.748 von Macos am 25.07.09 13:16:57Es gibt genug aussichtsreiche Aktien , im moment hat es mir ein Schweinegrippe-Player angetan die vor wenigen Wochen einen Test auf den Markt gebracht haben montag werde ich einsteigen .
Antwort auf Beitrag Nr.: 37.645.765 von BrauchGeld am 25.07.09 13:24:11sowas ist natürlich interessant! da hab ich NVAX
Antwort auf Beitrag Nr.: 37.645.796 von Macos am 25.07.09 13:36:13Für meinen geschmack ist NVAX viel zu teuer und zu riskant, ich kaufe lieber was unbekannt ist diese strategie zahlt sich fast immer aus ..
ladet euch mal den Biomedsreport von acces, ganz unten runter
http://biomedreports.com/research/cat_view/41-stock-research…
http://biomedreports.com/research/cat_view/41-stock-research…
Access Pharmaceuticals Announces Commercial Launch of MuGard(TM) in Norway by SpePharmEarly Market Assessment Studies Suggest Larger Market Potential
http://finance.yahoo.com/news/Access-Pharmaceuticals-prnews-…
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ACCP.OB ...Das Geld liegt auf der Straße lol
