HNAB - THE NEXT BIG SMALLCAP BIOTECH PLAY - LUKEMIA NDA
Hana Biosciences To Release Critical Flagship Product Trial Results At ASCO On May 20th, 2010
Many experts and inside sources are banking that the abstracts will be highly positive leading to it becoming one of the highest gaining small cap stocks this year
Dear Traders,
They are about to commence a rolling NDA submission for Marqibo after their meeting with FDA this quarter (pivotal phase 2 trial has been completed and if all goes as planned, the NDA will be submitted for treatment of 2nd relapse ALL in the 2nd half of 2010). Hana is greatly undervalued here, in our opinion. Late last year (2009), they were delisted from NASDAQ due to not meeting the minimum stockholders equity requirement. In December 2009, Hana announced results from their pivotal phase 2 study in ALL, the data was positive, but the stock took a tumble almost down to the 52wk low. The data is supposed to be updated at ASCO this June, which should provide a nice pop in the share price.
Marqibo is a version of an already used chemotherapeutic, but it is much more effective because it is built upon optisome nanoparticle technology (or "optiosmes"). Optisomes are a new generation of unique sphingomyelin/ cholesterol-based nanoparticles designed to encapsulate cell cycle-specific chemotherapeutics. Marqibo is being tested in multiple indications: front-line elderly PH(-) ALL, front-line aggresive NHL, pediatric cancers, and multiple myeloma.
But, Marqibo is not Hana's only product. They also have Alocrest (for the treatment of breast and lung cancer), Brakiva (for the treatment of SCLC and ovarian cancer), and Menandione Topical Lotion (for the treatment of skin rash associated w/ EGFR inhibitors. Examples of EGFR inhibitors are Tarceva®, Erbitux® and Vectibix®.). Please note, however, that these other three compounds are in early stages of testing (i.e phase 1 or 2).
Make sure to take a look at Hana's corporate presentation from January 11, 2010.
FDA Updates
Marqibo, vincristine sulfate liposomes injection, expects to submit NDA mid-2010 seeking accelerated approval for Marqibo based on phase 2 RALLY study results for treatment of adult acute lymphoblastic leukemia (ALL) ando ther data in solid tumors, planned pre-NDA meeting 2Q10, will present complete pivotal Phase 2 data at ASCO 06/07/2010
Menadione Topical Lotion - A topical compound for skin rash associated with Epidermal Growth Factor Receptor inhibitors such as Tarceva, Erbitux, and Vectibix, expects to provide intellectual property (IP) update mid-2010, present top-line proof-of-concept date mid-2010, also to begin phase 2 study 2H10.
On 12/7/09, HNAB.OB announcd data from its pivotal phase 2 RALLY clinical trial for Marqibo (vincristine sulfate liposomes injection) for treatment of adult acute lymphoblastic leukemia (ALL) in second relapse. The analysis of the first 56 evaluable subjects demonstrated an overall response in 36% of the subjects and a complete hematologic recovery (CRi) in 21% of subjects. The estimated median overall survival in complete responders was 7.3 months. 50% of the complete responders were able to receive potentially life-saving stem cell transplant. 50% of the complete responders had remission durations longer than the duration of their prior remission. In addition, Marqibo was generally well-tolerated with a low incidence of early death. Based on the RALLY trial data, other published Marqibo data in adult ALL, and supportive data in lymphomas and solid tumors, HNAB.OB plans to submit a New Drug Application (NDA) seeking accelerated approval for Marqibo in 2010. In addition, final data on all 65 subjects enrolled and dosed in phase 2 RALLY trial willbe presented in 2010.
If all goes as it should, Hana could be one of the biggest "BioShockers" of the year.
check it out!
