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Dec. 3, 2015, 12:40 PM
- Thinly traded nano cap Soligenix (OTCQB:SNGX -27.5%) slumps again today on a 5x surge in volume. Shares are down over 40% over the past two days on no particular news.
- The company is sponsoring one ongoing clinical trial, a Phase 2 evaluating Fast Track-tagged SGX942, a 5-amino acid peptide, for the treatment of oral mucositis (OM) in head and neck cancer patients undergoing chemo and/or radiation treatment. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint, improvement in OM symptoms four weeks after the end of therapy, is December 2015. The estimated study completion date is August 2016.
- On November 25, the FDA designated Cellceutix's (OTCPK:CTIX) Phase 2-stage oral rinse, Brilacidin-OM, for Fast Track review for OM. The oral rinse formulation presents a distinct advantage over SGX942's intravenous route of administration.
- A Phase 3 study evaluating SGX301, photoactivated hypericin, for the treatment of cutaneous T-cell lymphoma is set to begin shortly. The primary endpoint is the response in three treated lesions defined as at least a 50% improvement in CAILS score (a composite measurement) compared to placebo. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2016. The estimated study completion date is October 2017. SGX301 is designated an Orphan Drug in both the U.S. and Europe for the indication.
- Previously: Cellceutix's Brilacidin-OM Fast Track'd for oral mucositis (Nov. 25)
Jul. 17, 2015, 12:37 PM
- Thinly traded Cellceutix (OTCPK:CTIX +12.9%) heads north again on increased volume. Shares are up over 30% the past three trading days. The party got started on Wednesday when the company announced that the FDA designated Kevetrin an Orphan Drug for the treatment of ovarian cancer.
- Kevetrin, a small molecule compound currently in Phase 1 development, induces the activation of a tumor suppressor protein called p53.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Jan. 20, 2015, 1:11 PM
- Micro cap Cellceutix (OTCPK:CTIX +17.8%) jumps on a 2x surge in volume in response to its announcement of the complete disappearance of a metastatic lesion in the spleen of a Stage 4 ovarian cancer patient who was enrolled in the company's Phase 1 study of Kevetrin. The patient completed three cycles of treatment (three doses per cycle) before discontinuing the trial. Scans of the spleen showed the lesion to be essentially undetectable and the patient's disease clinically stable. The clinical trial is ongoing.
- Kevetrin is a small molecule drug that induces the activation of p53, a tumor suppressor protein often referred to as the "Guardian Angel Gene" because of its prominent role in controlling cell mutations.
Dec. 8, 2014, 1:23 PM
- Micro cap Cellceutix (OTCPK:CTIX +22.1%) jumps on a 5x surge in volume after the FDA grants Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The company is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.
- Brilacidin is a member of a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the "front line" of defense in the human immune system.
- In a Phase 2b clinical trial, a single dose of Brilacidin demonstrated equivalent effectiveness as a seven-day regimen of daptomycin (CBST +35.4%) for the treatment of ABSSSI.
- Among the benefits of QIDP is Fast Track and Priority Review status and a five-year period of market exclusivity if approved.
An early stage developmental biopharmaceutical company...with six pharmaceutical compound candidates that are designed for treatment of diseases which may be either existing or diseases identified in the future. The Company will initially spend most of its efforts and resources on its... More
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