Arena Pharmaceuticals Inc., of San Diego, said initial study results for APD668, an oral diabetes candidate, suggest that glucose-dependent insulinotropic receptors (GDIRs) might improve glucose control in patients with Type II diabetes. APD669 is partnered with Ortho-McNeil Pharmaceutical Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson. Based on results from those studies, which evaluated the drug in healthy volunteers and patients, Ortho-McNeil has decided to put the program on hold, with plans to advance a potentially more potent Arena-discovered GDIR agonist into preclinical development.
Can-Fite BioPharma Ltd., of Petach Tikva, Israel, said the FDA cleared the firm to start Phase I testing of its second drug candidate, CF102, a targeted drug designed to bind to the A3 adenosine receptor expressed on cancer cells. A Phase I study in healthy volunteers is expected to start shortly, with results published by the end of the first quarter. Can-Fite intends to develop CF102 in liver cancer and other liver pathologies. The company also reported receiving $500,000 from its Japanese partner, Seikagaku Corp., of Tokyo, which represents part of the royalties Seikagaku agreed to pay under the companies' licensing agreement to develop and market Can-Fite's lead drug, CF101, for autoimmune diseases in Japan.
Chemokine Therapeutics Corp., of Vancouver, British Columbia, said it has received approval from the FDA to start a Phase II study of CTCE-9908, a peptide analogue of the chemokine SDF-1, and an antagonist of its receptor CXCR4, in patients with liver cancer. The multicenter, randomized, controlled, open-label study will assess the efficacy and safety of CTCE-9908 administered at a dose of 5 mg/kg. The primary endpoint will be to determine the response rate of tumors in patients with liver cancer treated with CTCE-9908 following transarterial chemoembolization, a therapy used for nonresectable liver cancer, compared with patients receiving TACE alone.
Compellis Pharmaceuticals Inc., of Boston, said its collaborator Pennington Biomedical Research Institute at Louisiana State University has received approval from the FDA to start human clinical Phase I studies of its antiobesity compound CP404, a calcium channel blocker used in a nasal formulation to block olfactory activity and alter behavior to reduce food intake. Enrollment for the program will begin in the first quarter of 2008 with an expected completion date in the second half of the year, the company said.
Corthera Inc., of San Mateo, Calif., initiated a Phase II trial of Relaxin in acute heart failure. The randomized, double-blind, placebo-controlled trial will enroll 330 patients. Corthera is a naturally occurring peptide hormone that acts as a targeted vasodilator with systemic and renal hemodynamic effects.
Emergent BioSolutions Inc., of Rockville, Md., said a final analysis from a recently completed, randomized, placebo-controlled, blinded Phase II clinical study showed that 97 percent of children developed an immune response after receiving a single-dose of the firm's drinkable typhoid vaccine candidate. For the study, 151 Vietnamese children ages 5 to 14 were enrolled, with 101 children administered the vaccine candidate and 50 the placebo. About 93 percent of the children developed responses as measured by increases in Salmonella typhi LPS-specific IgG antibody levels suggestive of systemic protective immunity, and 94 percent developed an immune response as measured by increase in Salmonella typhi LPS-specific IgA antibody levels suggestive of mucosal protective immunity, the company said. No serious adverse events or deaths were reported.
Glycotex Inc., of Rockville, Md., received FDA clearance to begin a randomized, double-blind, placebo-controlled, Phase IIa trial with GLYC-101 for the topical treatment of burn wounds. GLYC-101 is designed to stimulate and modulate the natural cascade of wound healing.
Halozyme Therapeutics Inc., of San Diego, reported data from a volunteer subject study showing that clinically relevant fluid volumes can be delivered rapidly subcutaneously with Hylenex in a well-tolerated manner without the need for an infusion pump. Those findings, published in the Journal of Palliative Medicine, suggested that method of hydration potentially could replace intravenous infusions and that further studies with Hylenex in patients are warranted. Hylenex is a liquid injectable drug formulation that includes recombinant human hyaluronidase and is approved as a spreading agent to increase the absorption and dispersion of other injected drugs and for subcutaneous fluid administration.
Icagen Inc., of Research Triangle Park, N.C., said the FDA accepted its investigational new drug application for senicapoc, an oral small-molecule inhibitor of the KCa3.1 potassium ion channel, in asthma. The IND submission was based on data linking KCa3.1 to immune cell activation and cellular proliferation and efficacy data from a recent study showing the ability of senicapoc to reverse the antigen-induced changes in late phase airway resistance and airway hyperactivity in a sheep model of asthma. Dosing of subjects in a Phase Ib trial will begin later this month, and the firm expects to start Phase II testing in the second half of this year.
Incyte Corp., of Wilmington, Del., reported that preliminary results from an ongoing 28-day Phase IIa placebo-controlled, dose-ranging trial showed that three of four patients with rheumatoid arthritis administered INCB18424, an oral JAK inhibitor, have achieved ACR50 criteria, and two of whom also met ACR90 criteria, one within two weeks. The two patients receiving placebo have not shown significant responses, the firm said. In addition, the company reported that results from an ongoing Phase Ib/IIa trial of 25-mg INCB18424 was effective in patients with myelofibrosis, a serious neoplastic condition characterized by bone marrow failure, life-threatening splenic enlargement. Results from a 28-day Phase IIa trial of the topical form of INCB18424 in patients with mild-to-moderate psoriasis showed that the compound provides at least comparable efficacy to the topical steroid diprolene, the firm said. Data from a Phase IIa 28-day hyperinsulinemic clamp study in patients with Type II diabetics showed that INCB13739, an oral 11-beta-HSD1 inhibitor improved fasting plasma glucose, LDL cholesterol, total cholesterol, triglycerides, clamp-measured liver glucose production and clamp-measured peripheral glucose uptake, Incyte said. Based on those results, the company said it plans to initiate a three-month Phase IIb study to evaluate multiple once-daily doses of INCB13739 in combination with metformin in patients with Type II diabetes with poorly controlled hyperglycemia.
Javelin Pharmaceuticals Inc., of Cambridge, Mass., said results of a Phase I study of Dyloject (injectable diclofenac sodium) showed minimal effects upon platelet function at a clinically effective dose, in contrast to aspirin and ketorolac, which each impaired platelet aggregation significantly. Findings were presented at the JPMorgan Healthcare Conference in San Francisco.
Medarex Inc., of Princeton, N.J., said the FDA cleared its investigational new drug application for MDX-1411, a fully human monoclonal antibody targeting CD70-expressing cancers. Medarex plans to initiate a 40-patient, open-label, dose-escalation, multidose Phase I trial in clear cell renal cell carcinoma.
Nastech Pharmaceutical Co., of Bothell, Wash., completed enrollment of 551 patients in its Phase II trial of PYY3-36 Nasal Spray for obesity. The randomized study will compare multiple doses of PYY3-36 Nasal Spray to placebo and Meridia (sibutramine HCl monohydrate capsules C-IV, Abbott). PYY is a naturally occurring hormone thought to act as a physiologic inhibitor of food intake.
Nektar Therapeutics Inc., of San Carlos, Calif., started a Phase II program to test NKTR-102 (PEG-irinotecan), the firm's lead oncolytic candidate using its small-molecule PEGylation platform, in colorectal cancer. The first study in the program will investigate the drug in combination with cetuximab (Erbitux, ImClone Systems Inc.) in second-line colorectal cancer in irinotecan-naïve patients vs. cetuximab plus standard irinotecan. That study will have two parts. The Phase IIa portion will be a dose-finding trial in multiple solid tumor types refractory to curative or palliative therapies, while the Phase IIb portion will randomize patients to receive cetuximab plus either irinotecan or NKTR-102. The Phase IIb stage is expected to begin in mid-2008 and will measure progression-free survival as its primary endpoint. Secondary endpoints include response rate, response duration, overall survival, standard pharmacokinetics and incidence of toxicities.
Neurogen Corp., of Branford, Conn., said based on results of a follow-up component of a Phase I multiple-ascending-dose (MAD) study with NGD-4715, an MCH-1 receptor antagonist being investigated for the treatment of obesity, it will not advance the compound into Phase II testing at this time, but will consider an out-licensing deal. The initial phase of the MAD study used three-times-daily dosing for 14 days in healthy obese subjects exposed to a high caloric diet in which moderate induction of the liver enzyme CYP 3A4 occurred, increasing the probability of accelerating metabolism of other drugs administered concomitantly. In addition, lipid-lowering effects were observed. In the follow-up study, CYP3A4 induction was reduced substantially as measured by treatment with midazolam, a drug sensitive to changes in CYP 3A4 levels. However, no effect on lipids was observed, the company said.
Seattle Genetics Inc., of Seattle, said it will receive a $4 million milestone payment from partner Genentech Inc., of South San Francisco, due to Genentech's initiation of a Phase Ib trial of SGN-40 in combination with Rituxan (rituximab) for relapsed follicular or marginal zone non-Hodgkin lymphoma. SGN-40 is a humanized monoclonal antibody targeting the CD40 antigen. Genentech is conducting Phase I and Phase II trials with the drug in NHL and multiple myeloma, following a potential $860 million deal signed with Seattle Genetics early last year. (See BioWorld Today, Jan. 9, 2007.)
Surface Logix, of Boston, said results of a randomized, double-blind, placebo-controlled crossover Phase IIa study in 60 patients with uncontrolled hypertension demonstrated that SLx-2101 caused clinically significant reductions in blood pressure and was well tolerated. The trial was designed to examine the safety, tolerability and effect on blood pressure in patients of repeat once-daily oral doses for 14 days of SLx-2101, an oral, selective, fast-onset, long-acting PDE5 inhibitor. While PDE5 inhibitors typically are used to treat erectile dysfunction, the firm said it designed SLx-2101 to expand the therapeutic potential of PDE5 inhibition beyond the condition into larger cardiovascular markets, such as hypertension.
ZymoGenetics Inc., of Seattle, initiated a Phase II trial of recombinant Interleukin 21 (IL-21) combined with Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer Pharmaceuticals Corp.) in advanced renal cell cancer. The 30-patient, open-label study will build on a recently completed Phase I trial. ZymoGenetics also is studying IL-21 in metastatic melanoma.