Farmas USA

http://www.streetinsider.com/Corporate+News/Immunomedics+%28IMMU%29+Announces+Positive+Complete+Response+Data+from+Sacituzumab+Govitecan+Study+in+TNBC/10610385.html?si_client=intbro

IMMU

Edito: +8,55% en pre, aunque con tan solo 100 títulos.....

Bueno, voy a observar las ONTY a ver como se comportan en esta compleja situación, es decir, un rally previo del copon con roturas de resistencia bajista de largo plazo y ahora un gap ... post news. De aqui lo mismo aprendemos algo.

Tenemos en pre 250k cromos y subiendo, aun quedan 2 horas para apertura

De momento, pre minimo 4,25 , pre maximo 5,35

Vaya lio! el gap que habia hasta los 4,38 ... ahora tenemos otro mas grande, el que se esta formando ahora.

THLD, ¿vender en 4,62 (si llegamos) o aguantar?

THLD

Primero tiene que pasarte los 4,45 ... 

THLD

CLSN

Celsion Presents GEN-1 Immunotherapy Phase 1b Results in Recurrent Ovarian Cancer at ASCO 2015

announced the presentation of clinical results from its Phase IB trial for GEN-1 in platinum-resistant ovarian cancer in a poster session by Dr. Premal H. Thaker, M.D., associate professor at Washington University and Siteman Cancer Center in St. Louis, on Saturday, May 30th at the 2015 American Society of Clinical Oncology (ASCO) Meeting in Chicago. GEN-1 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. The poster presentation is available on Celsion's website at http://www.celsion.com.

The Phase 1B dose escalating study enrolled 16 patients with platinum-resistant ovarian cancer and evaluated the safety, tolerability and efficacy of GEN-1 in combination with pegylated doxorubicin as well as the effect of intraperitoneal injection of GEN-1 on IL-12 and tumor cytokine levels. Patients received pegylated liposomal doxorubicin on day 1 and GEN-1 on days 1, 8, 15 and 22. This treatment regimen was repeated every 28 days in the absence of disease progression or toxicity.

The clinical findings demonstrated an overall clinical benefit of 57% for all treatment arms, with a partial response (PR) rate of 21% and a stable disease (SD) rate of 36%. The overall clinical benefit observed at the highest dose cohort in this difficult-to-treat patient population was 100% (PR=33% and SD=67%) in all six evaluable patients. GEN-1 was well tolerated, with no dose limiting toxicities and no overlapping toxicities between GEN-1 and pegylated doxorubicin.

"These clinical results are very encouraging, especially given the fact that patients suffering from advanced relapsed ovarian cancer have typically failed previous treatments and have limited treatment options for this aggressive cancer. GEN-1 is a novel immunotherapy designed to enhance the patient's immune system to help the body treat and fight cancer," said Dr. Thaker. "I am pleased to be part of this important study and look forward to continuing my involvement with future trials of GEN-1 IL-12 immunotherapy in this underserved patient population."

Additional translational data measuring cytokine levels (IFN-gamma and TNF-alpha) at increased doses of GEN-1 will be available after the ASCO Meeting. Since the maximum tolerated dose was not reached in this study, Celsion plans to evaluate GEN-1 in a Phase 1 dose escalating trial in first line neoadjuvant ovarian cancer. Based on the significant clinical benefit observed in the Phase 1B study coupled with compelling preclinical data, the Company also plans to initiate a Phase 1B dose escalating trial evaluating GEN-1 plus Avastin® and Doxil® in platinum-resistant ovarian cancer patients, a combination which has the potential to significantly improve treatment outcomes for these patients.

In two preclinical studies using an animal model of disseminated ovarian cancer, GEN-1 in combination with Avastin® led to a significant reduction in tumor burden and disease progression. The effectiveness of the combined treatment was seen when GEN-1 was combined with various dose levels of Avastin® (low-medium-high). The preclinical studies indicated that no obvious overt toxicities were associated with the combined treatments.

The preclinical data are also consistent with the mechanism of action for GEN-1, which exhibits certain anti-angiogenic properties and suggests that combining GEN-1 with lower doses of Avastin® may enhance efficacy and help reduce the known toxicities associated with this anti-VEGF drug.

The distinct biological activities of GEN-1 (immune stimulation) and Avastin® (inhibition of tumor blood vessel formation) makes a sound scientific rationale for this combination approach. Additionally, the anti-angiogenic activity of GEN-1 mediated through up regulation of the interferon gamma (IFN-gamma) pathway may help to explain the remarkable synergy between GEN-1 and Avastin® and potentially addresses the VEGF escape mechanisms associated with resistance to Avastin® therapy.

"This impressive body of clinical and preclinical data warrants the continued development with escalating doses of GEN-1 and underscores the potential clinical utility of this immunotherapy in difficult-to-treat diseases like recurrent ovarian cancer," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion's proprietary TheraPlas™ platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer. GEN-1 has also demonstrated preclinical activity in glioblastoma multiforme (brain cancer) and the Company plans to initiate a Phase I study in this indication in the second half of 2015.

http://investor.celsion.com/releaseDetail.cfm?ReleaseID=915669

THLD

¿De verdad las veis tan arriba? Yo encantado, pero no imaginaba que la noticia conllevara una subida de esta envergadura...

Enrollment in Cellceutix Phase 2 Clinical Trial of Brilacidin-OM For Oral Mucositis Expanding to Additional Centers
BEVERLY, MA--(Marketwired - June 01, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that last week a second site opened enrollment in the Company's Phase 2 clinical trial of Brilacidin-OM for the prevention and treatment of oral mucositis in head and neck cancer patients undergoing chemoradiation. Clinical sites in Oregon and South Dakota are now enrolling patients to evaluate Brilacidin-OM for efficacy with additional sites to be added in June to keep the trial progressing in a timely manner.

More information on the trial can be found at https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=2.

Besides targeting the huge unmet medical need for an effective therapeutic for oral mucositis, the Brilacidin-OM trial has significant implications for Cellceutix shareholders. Should the anti-inflammatory properties of Brilacidin-OM work in the trial as anticipated, Cellceutix will immediately turn its attention to inflammatory diseases, such as hidradenitis suppurativa (HS) and gastrointestinal diseases, as planned. Cellceutix believes the potential market size for its defensin mimetics as anti-inflammatory compounds is even greater than the substantial market for antibiotic applications.

"We expect this trial of Brilacidin-OM to move efficiently and are very pleased to see another clinical site already open for enrolling patients," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "As this trial is underway we are completing the formulation work for treating hidradenitis suppurativa. Actually, the timing couldn't be better with the U.S. Food and Drug Administration recently granting AbbVie an orphan drug designation for HUMIRA® (adalimumab) for the investigational treatment of moderate-to-severe HS. The designation answered many questions for us and is certainly something we will apply for as well in order to try and shave millions of dollars and years off the clinical trials."

Cellceutix will be issuing a separate update on the events at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting shortly after its conclusion on Tuesday, June 2, 2015.

CTIX