Positive trial results for transdermal Lidocaine system
Medarex, Inc. has announced it has initiated a Phase 1b clinical trial for MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody for the treatment of cancer. Studies suggest that the PD-1 signaling pathway may play an important role in tumor evasion and escape from host immune responses and may
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Phosphagenics Limited has announced the successful completion of a phase 1 clinical trial that examined the ability of its patented drug delivery system, TPM, to topically deliver the pain relief drug, lidocaine, safely into humans.
The trial demonstrated that the patented lidocaine formulation was able to deliver a significantly greater amount of lidocaine into the localised area of the skin compared to a leading commercial product.
Lidocaine is a well known topical anaesthetic, sales of which exceeded US $1.2 billion in 2007. It is used for a wide variety of ailments, including temporary relief of rashes, stings, sprains, strains, bites, and burns. This clinical trial compared the dermal penetration and measured the systemic exposure of lidocaine between one of the leading marketed products, Xylocaine (5% lidocaine), and Phosphagenics’ TPM/lidocaine (5% lidocaine).
One hour after application, TPM/lidocaine delivered 500 percent more (p<0.001) lidocaine into the stratum corneum, the outer layer of the skin, than the commercial product, Xylocaine. Phosphagenics’ TPM/lidocaine also augmented the depth of penetration, with 450 percent (p<0.01) more lidocaine found in the deepest layers of the skin sampled.
TPM/lidocaine significantly increased the amount, rate, and depth of lidocaine penetration into the skin compared to Xylocaine, parameters that are normally expected to produce a local analgesic effect. Despite the increase in dermal drug delivery, TPM/lidocaine did not increase the plasma lidocaine concentration compared to Xylocaine after 6 hours.
Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics said; “While we have previously demonstrated the penetrative power of our TPM technology, the success of this trial validates the versatility and precision of Phosphagenics’ drug delivery platform in humans. We view this as a major achievement for our company and look forward to moving ahead with further clinical trials.”
The open label, single centre study was conducted at the Centre for Pharmaceutical Research, University of South Australia, under the guidance of Principal Investigator Dr. David Foster. 11 healthy adult volunteers enrolled in the bioavailability trial of dermal and systemic pharmacokinetics, which incorporated secondary endpoints of safety and tolerability.
Phosphagenics Limited (”Phosphagenics”) announced today that it has initiated a phase 1 human clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a leading non steroidal anti-inflammatory drug (NSAID), diclofenac. The trial will compare the bioavailability and penetration of the topically applied Voltaren(R) gel (1% diclofenac), one of the leading
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Contrary to a widely-held assumption about heterosexual transmission of HIV, the normal mucosal lining of the female genital tract is not a foolproof barrier to viral penetration, scientists at the Northwestern University School of Medicine in Chicago report at the American Society for Cell Biology (ASCB) 48th Annual Meeting, Dec. 13-17, 2008 in San Francisco.
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RHEI Pharmaceuticals, Inc. has announced that the final clinical trial for Tibozole, a locally active antifungal with low dose miconazole in a patented mucoadhesive system, has been initiated in China. This will be the last clinical trial conducted for submission of the New Drug Application (NDA) to the State Food and Drug Administration (SFDA) in China.
Full Post: RHEI Pharmaceuticals starts final trial of Tibozole in China
Researchers at Northwestern University have discovered a critical new way a man can transmit the HIV virus to a woman. Scientists had long believed that the normal lining of the female vaginal tract was an effective barrier to invasion of the HIV virus during sexual intercourse. They thought the large HIV virus couldn’t penetrate the
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Innocoll, Inc., a privately-held biopharmaceutical company, announced that the FDA has designated Gentamicin surgical implant as a Fast Track development program. Gentamicin surgical implant is currently being evaluated in two phase III clinical trials as an adjunct to systemic antibiotic administration for the prevention of surgical site infections in patients who are at higher
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