In The Pipeline
In The Pipeline
• CytRx Corp. has announced that its TranzFect technology is incorporated in an experimental DNA-based HIV vaccine being developed by Merck & Co. that has now entered Phase I clinical trials. Merck scientists hope the clinical trials will lead to the development of an HIV vaccine that can effectively prevent or attenuate the development of AIDS resulting from HIV infection, as well as help treat HIV infection in infected patients taking anti-retroviral therapy.
• BioStratum has successfully filed an Investigational New Drug Application for its
proprietary anticancer drug candidate, Angiocol, and has received clearance from the Food and Drug Administration to proceed to Phase I clinical trials. The initial Phase I study will evaluate the safety and pharmacokinetics of Angiocol in patients with cancer.
• Repligen Corp. has initiated its Phase III clinical trial program for secretin in pediatric autism. Based on feedback from the Food and Drug Administration, the Company intends to conduct two clinical trials, each of which will enroll approximately 175 children ages 2 years
8 months to 4 years 11 months with moderate to severe symptoms of autism. The two trials are identical in design with the exception that one of the trials will enroll only children with gastrointestinal symptoms.
• NeoPharm has been granted orphan drug status by the Food and Drug Administration for the company’s novel anti-mesothelin monoclonal antibody toxin, SS1-PE38, for both the treatment of mesothelioma and ovarian cancer.
• Progenics Pharmaceuticals has initiated a Phase IIb clinical trial of its investigational drug methylnaltrexone (MNTX) for the reversal of
narcotic-induced constipation. MNTX is designed to reverse the side effects of opioids without interfering with pain relief.
• Protein Polymer Technologies has added an additional clinical center to accelerate human clinical testing of its urethral bulking agent for the treatment of female stress urinary incontinence.
• EntreMed has initiated the University of California San Francisco (UCSF) as a second location for a Phase II clinical trial of its angiogenesis inhibitor, Endostatin, for neuroendocrine tumors. UCSF has commenced enrollment of patients, who will self-administer Endostatin at home using pre-filled syringes.
• Alexion Pharmaceuticals has completed enrollment in its first Phase II trial in patients suffering from a severe form of kidney disease known as membranous nephritis, with its anti-inflammatory C5 Inhibitor antibody, 5G1.1, now called eculizumab.
• Achillion Pharmaceuticals has commenced a Phase II clinical study with ACH-126,443 (beta-L-Fd4C) in patients with chronic hepatitis B infection.
• Scios has begun enrollment in a Phase IIa clinical trial evaluating SCIO-469, its novel oral p38 kinase inhibitor for the treatment of rheumatoid arthritis.
• Transgene has initiated a Phase II clinical trial of its immunotherapeutic MVA-HPV-IL2 vaccine candidate for the treatment of stage 2-3 cervical intra-epithelial neoplasia (CIN2-3). The trial will be conducted in France and will include up to 28 women with CIN2-3.
• Hybridon has initiated a Phase I/II clinical trial to study the combination of GEM(R)231, its second-generation antisense drug candidate, and the marketed antitumor chemotherapy agent, irinotecan (CPT-11; Camptosar) for patients with solid tumors. GEM(R)231 is an antisense inhibitor of the RI(alpha) subunit of protein kinase A.
• AtheroGenics has begun a Phase I clinical trial of AGI-1096 as an oral treatment for the prevention of organ transplant rejection. The Phase I trial is designed to assess the safety and tolerability of AGI-1096 in healthy volunteers.
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