Re: Farmas USA
GALE
Resumo la letra. Luego la parte de preguntas de los analistas parece muy interesante, pero yo básicamente no entiendo nada. Estaría bien que le echaras un vistacillo. Enlazo directamente esta parte:
http://seekingalpha.com/article/3670016-galena-biopharmas-gale-ceo-mark-schwartz-on-q3-2015-results-earnings-call-transcript?page=7&p=qanda&l=last
we now have four compounds and eight clinical trials in oncology
strategic decision to exit the commercial business
other significant expense affecting our overall loss from continuing operations relates to the non-cash charges from changes in the fair value of our warrant liabilities
expect to initiate a new Phase 2 NeuVax trial next year and overtime we expect to expand our overall pipeline through additional trials
we anticipate our quarterly burn rate to be between $9 million and $11 million for the next two quarters, which includes expenses of $1 million to $2 million related to the transition out of our commercial business. This does not include any proceeds we may receive from the divestiture.
NeuVax programs in breast cancer, where we currently have four trials; the registration of a single agent trial; two trials in combination with trastuzumab, all targeting secondary prevention; and importantly, a proof-of-principle Phase 2 trial in primary prevention in patients with DCIS.
NeuVax is a peptide derived from the HER2 protein that binds through the human leukocyte antigen or HLA and is combined with immune adjuvant GM-CSF.
- Our lead clinical trial is PRESENT. This is our pivotal Phase 3 single agent registration study targeting node-positive HER2, IHC 1+/2+ patients and is under a special FDA approved special protocol assessment.
we have not observed severe cardiac issues with the patients, commonly associated with HER2 targeted therapies. Our next major clinical milestone for this trial will be achieving a positive readout on our event-driven interim analysis, which will occur when we reach 70 events, defined as recurrence or death from any cause. we expect to reach this milestone in the first quarter of next year. safety and fatality analysis that will likely be reported in the second quarter of 2016.
- two mid-stage trials in combination with trastuzumab. first is a Phase 2b study in node-positive and triple negative HER2 IHC 1+ and 2+ patients. Our second combination trial expands our breast cancer presence to the HER2 IHC 3+ patients. This trial is treating women who high risk with node-positive or node-negative disease.
During the quarter, we also announced our collaboration with the National Cancer Institute or NCI on a new proof-of-concept Phase 2 clinical trial in women with ductal carcinoma in situ or DCIS. first is a Phase 2b study in node-positive and triple negative HER2 IHC 1+ and 2+ patients. Our second combination trial expands our breast cancer presence to the HER2 IHC 3+ patients. This trial is treating women who high risk with node-positive or node-negative disease.
During the quarter, we also announced our collaboration with the National Cancer Institute or NCI on a new proof-of-concept Phase 2 clinical trial in women with ductal carcinoma in situ or DCIS. The results from this study will enable us to design a Phase 3 clinical trial to test whether this vaccine prevents the development of invasive breast cancer in women with DCIS, potentially indicating the need for surgery. We expect to initiate the VADIS Phase 2 trial in the first quarter of next year.
- Both GALE-301 or E39 and GALE-302 or E39 prime, previously known as J65 are peptide vaccines derived from folate binding protein and are targeting the prevention of recurrence in ovarian, breast and endometrial cancers to disease where the recurrences are high.
* GALE-301: the 1,000 microgram group or optimal dose vaccine group, the two year disease free survival estimate at 85.7% versus 33.6% in the control group with a P value of 0.02. We are continuing to collect safety, immunologic and clinical recurrence data and expect to present and update in the first half of 2016.
* GALE-302 is an attenuated or weaker version of the E39 peptide. Folate binding protein is a highly expressed tumor associated antigen in many cancers, making it a very logical treatment target for active immunotherapy.
It also results in immunogenic peptide that have led to development of a potentially very potent vaccine. It is derived that this potency could lead to T-cell exhaustion in patient's overtime, leading to cancer immune evasion
Both vaccines are immunogenic and well-tolerated with no major safety differences between PVS sequences.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
