Tag: clinical study

Omnix Medical Receives U.S. FDA Approval of a Phase II Trial of its Next-Generation Anti-Infective OMN6

– Phase I data show safety and tolerability at clinically significant dose levels

– New class of anti-infectives to treat infections with Gram-negative bacteria

Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has approved a planned Phase II trial of the Company´s novel anti-infective OMN6.

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Company News: Legacy Healthcare Announces Breakthrough Clinical Results in Hair Re-growth

– CG210™ improves hair thickness in patients using finasteride –

Legacy Healthcare, a company developing innovative products for hair and scalp disorders with a special focus on oncology supportive care, today announced clinical results of a double-blind, placebo-controlled, long-term trial of its innovative CG210™ topical treatment in patients suffering from hair loss.

The primary endpoint of the 12-month clinical study in subjects already using finasteride 1mg as a treatment for hair loss was the increase of mean diameter of hair. Participants received topical CG210™ or topical placebo in addition to the oral finasteride 1mg they were already taking. Finasteride, a synthetic type-2 5α-reductase inhibitor, has been approved by the US FDA, among others, for the treatment of male pattern baldness (MPB). As of September 27, 2012, results from 16 volunteers, who completed a 12 month cycle, were analyzed. The mean diameter of hair of subjects receiving topical CG210 increased 36.9% more than the mean diameter of hair of subjects receiving topical placebo (p<0,0001). The study was conducted in Japan.

Company News: Study Demonstrates Micromet’s Blinatumomab Produces High Single-Agent Activity in Patients with Relapsed Acute Lymphoblastic Leukemia

– 75% of patients achieved a complete remission, with no evidence of remaining leukemic cells in blood or bone marrow –
– Data add to a growing body of clinical evidence demonstrating blinatumomab’s potential to be used across the course of the disease –

Data to be presented tomorrow at the 16th Annual Meeting of the European Hematology Association (EHA) in London, UK, show that Micromet’s blinatumomab produced a high complete remission rate in adult patients with acute lymphoblastic leukemia (ALL) who had relapsed following treatment with standard therapy. 1 Blinatumomab is the most advanced of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

Interim results from this phase 2 single-arm trial showed that 75% of patients (9 of 12) achieved a complete remission (CR) or CR with partial recovery of blood counts (CRh*) following treatment with blinatumomab.  All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival.  Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*.

Current treatment for Philadelphia negative relapsed/refractory ALL consists of combinations of toxic chemotherapy drugs that in the majority of cases fail to drive the disease into remission.  In more than 30 years, no new drug has been approved for use in this setting, leaving physicians with few options to improve long-term patient outcomes other than variations in the dose and schedule of old drugs with limited efficacy.  With current approaches, complete remission rates range from 17-45%. 2-6 Standard chemotherapy is associated with a mortality rate of up to 23%. 7 The average five-year survival rate for adult ALL patients after first relapse is 7%. 5

 

Click here to read the abstract

 

References:

  1. Topp, M.S. et. al. Haematologica. 2011; abstract no. 844
  2. Kantarjian H, et al. Cancer. 2010;116:5568–5574.
  3. Advani AS, et al. Br J Haematol. 2010;151(5):430.
  4. Oriol A, et al. Haematologica. 2010;98(4):589-596.
  5. Fielding  A, et al. Blood. 2007;109(3):944-950.
  6. O’Brien S, et al. Cancer. 2008;113:3186–3191.
  7. Bassan R, et al. J Clin Oncol. 2011;29(5):532-543.

Company News: SuppreMol Initiates Phase Ib/IIa Clinical Trial With Its Lead Candidate SM101

SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced the initiation of a Phase Ib/IIa clinical trial with its lead product SM101 in Idiopathic Thrombocytopenic Purpura (ITP) in Europe. For further details on the trial and the compound, please see the complete press release.

In a Phase Ia trial in 48 healthy volunteers started in April 2009, no SM101-associated adverse reactions have been observed. Detailed results of this study will be published soon.