OXGN
Han salido los datos trimestrales. No he visto si cumplen expectativas de analistas o no. Me he leído la transcripción y, bueno, hay cosillas pendientes de aquí a fin de año, pero ¿sabéis esas veces que percibo un lenguaje de fondo negativo? Pues eso. Me lo tengo que volver a estudiar con calma.
We have completed various clinical trials in different areas for our lead perfect candidate fosbretabulin including Anaplastic Thyroid Cancer, Platinum-Resistant Ovarian Cancer, non-small cell lung cancer and head and neck cancer. Unfortunately as is all too common in the drug development industry, not all of our clinical work has yielded clearly positive results.
we have accrued a great deal of knowledge about fosbretabulin, it's tolerability and safety profile, how it works in different settings and more importantly what it works best with in combination to achieve optimal results. What the company needs now is a specific and executable plan to take advantage of the knowledge OXiGENE has accrued from fosbretabulin.
We also carefully evaluating the clinical and regulatory risks as well as the commercial opportunities of various indications, again we aim to provide more detail and clarity on our path forward later this year. As a clear example of the potential power of a combination anti-vascular approach we recently have seen compelling data showing positive results from a randomized controlled Phase 2 clinical study in patients with recurrent ovarian cancer where fosbretabulin was combined with Avastin. The data was remarkable and suggest that the biologic activity of fosbretabulin is most effective when using combination with other anti-vascular agents. This makes scientific sense giving how each product works, fosbretabulin cuts off blood supply to tumors on the inside of the tumor while anti-angiogenic agents such as bevacizumab or pazopanib prevent formation of tumor vessels on the outside.
Based on the data from our Phase II combination clinical trial with fosbretabulin in ovarian cancer, we met with the FDA and we’re very pleased that they support part plan to move into Phase III trials for five members of ovarian cancer patients using combination anti-vascular therapy. We’re preparing a special protocol assessment for submission to the FDA later this year.
We also expect to receive other initial data soon from an ongoing study using this combination approach where fosbretabulin is being combined together with pazopanib as a potential new therapy for recurring ovarian cancer. We anticipate results from the dose range portion of this study known as [indiscernible] to be presented in October at a conference in France
The study is being sponsored by the Christie Hospital in the UK and the second stage will recruit upto 128 patients with both platinum sensitive and platinum resistant disease. A larger potential market opportunity than that for only platinum resistant patients. In addition some data suggest that pazopanib may also be a more potent anti-angiogenic agent than others in this class which could potentially increase the synergistic effects of combined therapy with fosbretabulin.
Moving onto other indications, this past quarter we have made progress recruiting patients for the ongoing Phase 2 study of fosbretabulin and patients with the most common type of neuroendocrine tumors or NETs focusing on those that occurred in the gastrointestinal tract, also known as GI-NETs.
this past quarter we have made progress recruiting patients for the ongoing Phase 2 study of fosbretabulin and patients with the most common type of neuroendocrine tumors or NETs focusing on those that occurred in the gastrointestinal tract, also known as GI-NETs.
Based on early data that we gathered we’re also in the final stages of amending this protocol to include patients with pancreatic neuroendocrine tumors or P-NETs to expand the potential patient population and to provide us with a more comprehensive insight into fosbretabulin's clinical activity in these tumors. We anticipate performing and reporting upon an interim analysis of initial data from this study by the end of this year.
we are considering studying other tumor types where there is a scientific basis for fosbretabulin as part of combination anti-vascular therapy. Given the demonstrated benefits of combining fosbretabulin with Avastin in ovarian cancer, I think there is a strong rationale for evaluating response to this combination in glioblastoma where there is a high unmet medical need.
Moving on to OXi4503, our other BDA and second stage clinical product in our pipeline. We intend soon to initiate an expanded Phase 1-2 study in Acute Myeloid Leukemi or AML and in patients with myelodysplastic syndrome. Our OXi4503 dual mechanism that inhibits tumor blood flow and has cytotoxic activity that is demonstrated a biological effect in AML animal models.
Our current plan is to initiate an open label dose escalation phase of the study enrolling approximately 20 patients to evaluate the safety profile and biologic activity of OXi4503, [indiscernible] identified for the study and the protocol has been submitted to FDA so we expect to start enrollment soon.
the burn was about $3 million in each of the first two quarters of this year. Third quarter is probably the same order of magnitude, fourth quarter maybe up a little bit depending on the number of patients in the trial but don’t forget in the pacifiers [ph] trial most of that cost is external from the company. So we don’t have a huge ramp up in that area. The preclinical work that’s going on at Baylor is preclinical so that’s relatively low in comparison to everything else. I think where you would really see the ramp up [de los gastos] is when we get into new clinical programs which would be sometimes subsequent to the end of this year.
«Después de nada, o después de todo/ supe que todo no era más que nada.»