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Monday, May 10, 2010 3:27:31 AM
HNAB.OB (.24) DD ASCO Post –Hana Biosciences Readies for Prime Time as ASCO 2010 nears!
Hana Biosciences is a late stage biopharmaceutical company that is focused on the acquisition, development, and commercialization of novel, improved cancer therapeutics and compounds that reduce cancer therapy toxicity.
This ASCO will feature updated clinical data from their lead asset compound, Marqibo® (vincristine sulfate liposomal injection) which has already demonstrated compelling evidence of single-agent, anti-leukemic efficacy in heavily pre-treated, adult ALL population.
-The Pivotal rALLy trial in relapsed adult ALL fully enrolled; 65 pts total and demonstrated a 36% overall response rate (ORR) and a 21% complete remission (CR) rate. They will file an NDA submission seeking accelerated approval in ALL in 2010
There other product candidates support their strong portfolio. They have Menadione Topical Lotion for EGFR inhibitor skin toxicity management. Their other products are Brakiva™ (topotecan liposome injection) for solid tumors and Alocrest™ (vinorelbine liposomal injection) for solid tumors.
At ASCO 2010 Hana Biosciences will be presenting at the Leukemia, Myelodysplasia, and Transplantation Oral Abstract Session. The date will be June 7th at 11:45am by Dr. Susan Mary O’Brien. It will be abstract #6507 titled: “Phase II study of Marqibo in adult patients with refractory or relapsed Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).
This data is very relevant as it is an oral abstract presentation at ASCO. Positive data was recently presented at ASH regarding HNAB’s Phase II study that Evaluated the safety and Efficacy of Weekly Doses of Marqibo in Adult Patients with Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia (Ph ALL) in Second Relapse or Who Progressed Following Two Treatment Lines.
The rALLY efficacy was demonstrated in 56 pts. The complete remission rate was 12 out of the 56 for 21%. The median CR duration was 4 months. The # of overall responders (ORR) were 20 (36%). As far as the safety, the highest grade 3 toxicity was peripheral neuropathy at 21%. Neuropathies were mostly peripheral neuropathy, hypoaesthesia, and paraesthesia. There were no cases of chemical cellulitis or hand-foot syndrome. The 14-day mortality 3/56 (5.4%); 31-day mortality 8/56 (14.3%).
From the rALLy study presented in December at 2009 ASH, Marqibo demonstrated Positive Data.
-Compelling single-agent, anti-leukemic efficacy in a relapsed/refractory, heavily pre-treated, adult ALL population. They also induced CR/Cri (comp remission or CR without full hematologic recovery) associated w/ clinical benefit. The encapsulation technology facilitated dose-escalation and cumulative vincristine exposure in a majority of subjects. There was modest neuropathy and early death and despite the cumulative doses delivered and subject history of prior vincristine, Marqibo safety was consistent with the standard dose and formulated vincristine.
This study was important because dose limiting toxicities have restricted the standard use of Vincristine. Vincristine has been used to treat leukemias and lymphomas for over 40 yrs. Vincristine was the “backbone” of chemotherapy in a number of regimens (R-CHOP, R-CVP, CVAD, and VAD). It has also sold greater than 1.2 million doses in the US per year. The Dose-limiting early toxicity limits standard formulation vincristine efficacy, market expansion, and commercial success. The challenges were also individual doses were capped at 2.0mg regardless of pt size, there was also frequent early onset neuropathy, and there was limited cumulative dosing during lymphoma treatment and ALL induction. HANA Biosciences has an Optisome™ technology that offers a solution to vincristine’s limitations. Marqibo’s states that their unique Sphingomyelin-based Liposome Technology optimizes the pharmacokinetics and pharmacodynamics of the Vincristine. From the rALLy study presented in December, Marqibo demonstrated the potential to improve Vincristine Dosing & Efficacy. Marqibo enhanced vincristine tumor penetration and concentration by delivering 2.25mg/m2 of vincrisine w/o any dose cap. There was 2X or greater the amount of vincristine per dose in most patients and Marqibo facilitated increased cumulative vincristine dosing of up to 70mg.
-Marqibo has potential in cancers that are currently treated with vincristine (i.e. ALL, NHL, HD, and MM) and could replace vincristine in common regimens. Marqibo has IP protection through 2021 with additional IP pending.
What lies ahead for Hana Biosciences? A lot of potential with Marqibo as well in Second Relapse ALL (acute lymphoblastic leukemia) is a promising candidate for accelerated approval in the near term. There are currently no treatments or standard of care for second relapsed adult ALL. Pts w/ second relapsed adult ALL have been heaily pre-treated and have progressed following two prior lines of therapy. Clinicians believe there is a high unmet need for this very ill patient population. This has been demonstrated in a regulatory strategy that has been successful for other product candidates with single-arm registration trials. The products have been Dasatinib (BMS), Nelarabine (GSK), Clofarabine (Genzyme), and Pralatrexate (Allos). Marqibo has received Orphan Drug Status and Fast Track Designation from the FDA for Second Relapse ALL.
Future Studies Planned for Marqibo that could potentially increase the value of Hana Biosciences
• Randomized Phase III study of dose-dense R-CHMP versus dose-dense R-CHOP in elderly patients with newly diagnosed high-grade, B-cell non-Hodgkins’s lymphoma. –German High Grade Non-Hodgkin’s Lymphoma Study Group
• Pediatric Phase I study including comparative PK in children and adolescents with refractory cancer with an ALL arm –Study supported by 5 yr clinical trial agreement with Center for Cancer Research at the National Cancer Institute for co-development of Marqibo in refractory pediatric cancer
• Randomized Phase III study of a front-line, standard combination regimen including Marqibo or standard vincristine in elderly patient with ALL- SWOG lead, with intergroup (ECOG & CALGB) and potentially ex-US cooperative groups
There are significant near-term events for HANA and their drug Marqibo that can move the share price much higher. The most significant near term is the Final Marqibo rALLy data that will be presented (Oral Abstract Presentation) at ASCO on June 7th. That is a very important meeting for HANA at the biggest Oncology meeting of 2010. This significant data will initiate a rolling NDA submission for Marqibo in adult ALL. Financially the company is a mess with 22 million in debt. The company has cash sufficient only through Marqibo NDA submission process at which their hope for a potential suitor for this drug will be readily available. The company has 100 mill shares auth; 82 mill O/S, and roughly 70 mill in the float giving them a market cap of only 20 million dollars. The fact that this company has a single catalyst (ASCO Oral Presentation) that can make or break HNAB makes this a high risk/ high reward story.
Message in reply to:
$heff - what are your thoughts on HNAB (0.235) going into ASCO? They are doing an oral abstract presentation and are presenting complete data from the phase 2 trial of Marqibo in Acute Lymphoblastic Leukemia. Please see below:
Hana Biosciences to Present Complete Data From Pivotal Phase 2 Trial of Marqibo in Acute Lymphoblastic Leukemia at American Society of Clinical Oncology 2010 Annual Meeting
SOUTH SAN FRANCISCO, Calif., April 22, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that complete data from its pivotal study of Marqibo(R) in patients with relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL), have been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois.
The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.
About Marqibo(R) (vincristine sulfate liposomes injection)
Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of vincristine sulfate, a widely-used chemotherapy, which has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike standard vincristine, Marqibo is dosed to deliver 2.25mg/m2 of vincristine based on actual patient body surface area without the need for dose-capping.
Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
About Hana Biosciences
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities, some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at http://www.hanabiosciences.com/.
Hana Biosciences is a late stage biopharmaceutical company that is focused on the acquisition, development, and commercialization of novel, improved cancer therapeutics and compounds that reduce cancer therapy toxicity.
This ASCO will feature updated clinical data from their lead asset compound, Marqibo® (vincristine sulfate liposomal injection) which has already demonstrated compelling evidence of single-agent, anti-leukemic efficacy in heavily pre-treated, adult ALL population.
-The Pivotal rALLy trial in relapsed adult ALL fully enrolled; 65 pts total and demonstrated a 36% overall response rate (ORR) and a 21% complete remission (CR) rate. They will file an NDA submission seeking accelerated approval in ALL in 2010
There other product candidates support their strong portfolio. They have Menadione Topical Lotion for EGFR inhibitor skin toxicity management. Their other products are Brakiva™ (topotecan liposome injection) for solid tumors and Alocrest™ (vinorelbine liposomal injection) for solid tumors.
At ASCO 2010 Hana Biosciences will be presenting at the Leukemia, Myelodysplasia, and Transplantation Oral Abstract Session. The date will be June 7th at 11:45am by Dr. Susan Mary O’Brien. It will be abstract #6507 titled: “Phase II study of Marqibo in adult patients with refractory or relapsed Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).
This data is very relevant as it is an oral abstract presentation at ASCO. Positive data was recently presented at ASH regarding HNAB’s Phase II study that Evaluated the safety and Efficacy of Weekly Doses of Marqibo in Adult Patients with Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia (Ph ALL) in Second Relapse or Who Progressed Following Two Treatment Lines.
The rALLY efficacy was demonstrated in 56 pts. The complete remission rate was 12 out of the 56 for 21%. The median CR duration was 4 months. The # of overall responders (ORR) were 20 (36%). As far as the safety, the highest grade 3 toxicity was peripheral neuropathy at 21%. Neuropathies were mostly peripheral neuropathy, hypoaesthesia, and paraesthesia. There were no cases of chemical cellulitis or hand-foot syndrome. The 14-day mortality 3/56 (5.4%); 31-day mortality 8/56 (14.3%).
From the rALLy study presented in December at 2009 ASH, Marqibo demonstrated Positive Data.
-Compelling single-agent, anti-leukemic efficacy in a relapsed/refractory, heavily pre-treated, adult ALL population. They also induced CR/Cri (comp remission or CR without full hematologic recovery) associated w/ clinical benefit. The encapsulation technology facilitated dose-escalation and cumulative vincristine exposure in a majority of subjects. There was modest neuropathy and early death and despite the cumulative doses delivered and subject history of prior vincristine, Marqibo safety was consistent with the standard dose and formulated vincristine.
This study was important because dose limiting toxicities have restricted the standard use of Vincristine. Vincristine has been used to treat leukemias and lymphomas for over 40 yrs. Vincristine was the “backbone” of chemotherapy in a number of regimens (R-CHOP, R-CVP, CVAD, and VAD). It has also sold greater than 1.2 million doses in the US per year. The Dose-limiting early toxicity limits standard formulation vincristine efficacy, market expansion, and commercial success. The challenges were also individual doses were capped at 2.0mg regardless of pt size, there was also frequent early onset neuropathy, and there was limited cumulative dosing during lymphoma treatment and ALL induction. HANA Biosciences has an Optisome™ technology that offers a solution to vincristine’s limitations. Marqibo’s states that their unique Sphingomyelin-based Liposome Technology optimizes the pharmacokinetics and pharmacodynamics of the Vincristine. From the rALLy study presented in December, Marqibo demonstrated the potential to improve Vincristine Dosing & Efficacy. Marqibo enhanced vincristine tumor penetration and concentration by delivering 2.25mg/m2 of vincrisine w/o any dose cap. There was 2X or greater the amount of vincristine per dose in most patients and Marqibo facilitated increased cumulative vincristine dosing of up to 70mg.
-Marqibo has potential in cancers that are currently treated with vincristine (i.e. ALL, NHL, HD, and MM) and could replace vincristine in common regimens. Marqibo has IP protection through 2021 with additional IP pending.
What lies ahead for Hana Biosciences? A lot of potential with Marqibo as well in Second Relapse ALL (acute lymphoblastic leukemia) is a promising candidate for accelerated approval in the near term. There are currently no treatments or standard of care for second relapsed adult ALL. Pts w/ second relapsed adult ALL have been heaily pre-treated and have progressed following two prior lines of therapy. Clinicians believe there is a high unmet need for this very ill patient population. This has been demonstrated in a regulatory strategy that has been successful for other product candidates with single-arm registration trials. The products have been Dasatinib (BMS), Nelarabine (GSK), Clofarabine (Genzyme), and Pralatrexate (Allos). Marqibo has received Orphan Drug Status and Fast Track Designation from the FDA for Second Relapse ALL.
Future Studies Planned for Marqibo that could potentially increase the value of Hana Biosciences
• Randomized Phase III study of dose-dense R-CHMP versus dose-dense R-CHOP in elderly patients with newly diagnosed high-grade, B-cell non-Hodgkins’s lymphoma. –German High Grade Non-Hodgkin’s Lymphoma Study Group
• Pediatric Phase I study including comparative PK in children and adolescents with refractory cancer with an ALL arm –Study supported by 5 yr clinical trial agreement with Center for Cancer Research at the National Cancer Institute for co-development of Marqibo in refractory pediatric cancer
• Randomized Phase III study of a front-line, standard combination regimen including Marqibo or standard vincristine in elderly patient with ALL- SWOG lead, with intergroup (ECOG & CALGB) and potentially ex-US cooperative groups
There are significant near-term events for HANA and their drug Marqibo that can move the share price much higher. The most significant near term is the Final Marqibo rALLy data that will be presented (Oral Abstract Presentation) at ASCO on June 7th. That is a very important meeting for HANA at the biggest Oncology meeting of 2010. This significant data will initiate a rolling NDA submission for Marqibo in adult ALL. Financially the company is a mess with 22 million in debt. The company has cash sufficient only through Marqibo NDA submission process at which their hope for a potential suitor for this drug will be readily available. The company has 100 mill shares auth; 82 mill O/S, and roughly 70 mill in the float giving them a market cap of only 20 million dollars. The fact that this company has a single catalyst (ASCO Oral Presentation) that can make or break HNAB makes this a high risk/ high reward story.
Message in reply to:
$heff - what are your thoughts on HNAB (0.235) going into ASCO? They are doing an oral abstract presentation and are presenting complete data from the phase 2 trial of Marqibo in Acute Lymphoblastic Leukemia. Please see below:
Hana Biosciences to Present Complete Data From Pivotal Phase 2 Trial of Marqibo in Acute Lymphoblastic Leukemia at American Society of Clinical Oncology 2010 Annual Meeting
SOUTH SAN FRANCISCO, Calif., April 22, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that complete data from its pivotal study of Marqibo(R) in patients with relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL), have been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois.
The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.
About Marqibo(R) (vincristine sulfate liposomes injection)
Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of vincristine sulfate, a widely-used chemotherapy, which has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike standard vincristine, Marqibo is dosed to deliver 2.25mg/m2 of vincristine based on actual patient body surface area without the need for dose-capping.
Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
About Hana Biosciences
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities, some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at http://www.hanabiosciences.com/.
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