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Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) For The Treatment Of Fabry Disease
Amicus Therapeutics (Nasdaq: FOLD) announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease. The Company has reached agreement with the U.S. Food and Drug Administration (FDA) on the key protocol design elements of the pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the Company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations. The Company has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of this year.
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Positive Preclinical Data On 2 Product Candidates At ENDO 09 Presented By Versartis
Versartis, Inc., an emerging company developing novel biologics with enhanced properties for patients with metabolic diseases, presented data for its long-acting product candidates, VRS-317 (hGH-rPEG) for treatment of growth hormone deficiency and for VRS-826 (IL-1ra-rPEG) for treatment of type 1 and type 2 diabetes, at the Endocrine Society"s Annual Meeting in Washington, DC.
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Cancer Risk In Delaying Sex Assignment Surgery
An editorial and a case report on Disorders of Sexual Development (DSD) in the Medical Journal of Australia highlight the need for early diagnosis and effective risk management in these rare but potentially life threatening cases.
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Thallion Suspends Patient Enrollment Of TLN-232 Metastatic Melanoma Trial Over Licensing Dispute

Thallion Pharmaceuticals Inc. (TSX:TLN) announced that it has suspended patient enrollment in its Phase II trial evaluating TLN-232 as a treatment for metastatic melanoma, due to an ongoing dispute with the licensor. A binding arbitration proceeding has been initiated and Thallion will re-evaluate the status of the program based on the outcome of the adjudication. "Based on our experience with this licensor, it is in the best long-term interests of our shareholders to suspend development of TLN-232 as opposed to investing additional res to develop the product under recurring allegations of breach from the licensor and ensuing disputes over a termination of the license," said Lloyd M. Segal, Chief Executive Officer of Thallion Pharmaceuticals Inc. "We believe that the assertions made against us under the license agreement are without merit. We will vigorously defend our rights in this matter, and we intend to pursue claims of our own against the licensor during the proceedings. We believe this decision represents the most responsible course of action and is especially prudent in light of today"s constrained capital environment." About TLN-232 TLN-232 is a novel seven amino-acid peptide with potential efficacy in multiple oncology indications and targets pyruvate kinase M2 (M2PK), a protein shown to be over-expressed in a number of different tumour types. The expression of M2PK during tumourigenesis has been shown recently to mediate the Warburg effect, a phenotype in which cancer cells utilize the glycolytic pathway to a far greater extent than do their non-malignant counterparts. TLN-232 Phase II Trial Thallion"s multi-centre, open label Phase II trial is targeting to enroll up to 49 metastatic melanoma patients, who have failed one prior therapy, at multiple sites in both Canada and the U.S. The trial design is comprised of a dose escalation segment followed by a dose expansion segment. The first segment consists of consecutive cohorts of at least three patients each, who will receive 0.5, 1.0, 2.0 or 3.0 mg/kg/day of TLN-232 in multiple cycles. Each cycle will consist of 21 days of treatment and seven days of rest. Once the optimal dose has been determined, the second segment of the trial will enroll and treat up to 34 additional patients at that dose until disease progression. The primary endpoint of the trial is tumour response at four months. Thallion Pharmaceuticals Inc.


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