• Allos Therapeutics Inc., of Westminster, Colo., initiated patient enrollment in a Phase I/IIa trial of sequential PDX (pralatrexate) and gemcitabine with vitamin B12 and folic acid supplementation in patients with relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's disease. In the Phase I portion, patients will receive PDX followed the next day by gemcitabine as part of a weekly schedule for three or four weeks with concurrent vitamin B12 and folic acid supplementation, and the Phase IIa portion will enroll an additional 30 patients to assess preliminary efficacy of PDX and gemcitabine. PDX is a small-molecule chemotherapeutic agent designed to inhibit dihydrofolate reductase, a folic acid-dependent enzyme involved in the building of nucleic acids and other processes.

• Cobalis Corp., of Irvine, Calif., said it will delay the release of its Phase III trials of PreHistin due to concerns of apparent inconsistencies in the database for the Phase III trials. The company said concerns included the possibility of incorrect data entry in patient-symptom diaries, and said it must review source documents and conduct other quality control measures as part of its audit. The parallel Phase III trials involved 1,551 patients randomized to receive either 3.3 mg sublingual dosage of PreHistin or placebo twice daily for three weeks prior to the onset of the ragweed allergy season, followed by an additional three weeks into the allergy season. The primary efficacy parameter was the difference in the mean reduction in Total Nasal Symptom Score observed between the treatment and placebo groups over the fourth, fifth and sixth weeks.

• Gentium SpA, of Como, Italy, said results of an independent study supported the prophylactic treatment of patients post-allogeneic stem cell transplant with Defibrotide as a preventative therapy for veno-occlusive disease. Fifty-eight patients received Defibrotide twice-daily for 28 days. Results of the study demonstrated the effectiveness of the drug in reducing both the incidence of VOD as well as potentially severe hemorrhagic complications. No patient met the Baltimore criteria for VOD, and no patients died of suspected VOD within 100 days of transplantation. There were no cases of hemorrhagic complications attributable to Defibrotide. The data were published in Bone Marrow Transplantation.

• Insert Therapeutics Inc., of Pasadena, Calif., a subsidiary of Arrowhead Research Corp., said interim Phase I data of IT-101 in patients with inoperable or metastatic tumors show that the compound is well tolerated with a dose-limiting toxicity of pancytopenia. Results also showed that the stable disease rate, though not yet conclusive, is consistent with promising efficacy. IT-101 is a conjugate of the cancer drug camptothecin and Insert's Cyclosert drug delivery technology. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

• Introgen Therapeutics Inc., of Austin, Texas, reported data from a 22-patient Phase I/II trial of INGN 241, an mda-7/IL-24 tumor suppressor agent, in advance solid tumors. Data showed that the product induced killing in all treated tumors, including in patients who failed prior therapy with other cancer agents. INGN 241 also was well tolerated, and a maximum tolerated dose was not reached. Tumor growth control was observed in 44 percent of treated tumors, and two of five patients treated at the highest dose showed objective responses (greater than 50 percent reduction in tumor size). Those data were presented at the American Society of Gene Therapy meeting in Seattle.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., reported positive results from its 112-patient Phase IIb study of ecabet sodium, which is being developed for dry eye syndrome. Data showed that patients in the treatment group achieved a strong trend in the objective sign of blink rate, and also reported a strong trend in the Ocular Symptom Disease Index and a positive trend in the subjective assessment of patients' most bothersome symptoms. While the study was not powered to statistical significance, the drug did show statistical significance in the OSDI assessment. There were no reports of serious ocular adverse events compared with placebo. Further analyses of those results are ongoing. ISTA anticipates beginning Phase III studies in 2008.

• Marshall Edwards Inc., of Washington, said the first patient has been enrolled in a worldwide Phase III study evaluating oral phenoxodiol in combination with carboplatin in recurring ovarian cancer. The trial will enroll 470 patients randomized to receive either both products or carboplatin alone. Phenoxodiol has received fast-track designation in the U.S.

• Pharmacyclics Inc., of Sunnyvale, Calif., reported promising preliminary results from a Phase II trial of Xcytrin (motexafin gadolinium) injection, the company's lead cancer therapeutic, as a second-line treatment in recurrent metastatic non-small-cell lung cancer who failed at least one platinum-based chemotherapy regimen. Data showed that Xcytrin appeared to be well tolerated and, of the 58 evaluable patients, there was a confirmed response rate of 5.2 percent or three partial responses. Twenty patients (34.5 percent) had stable disease. Median time to progression was seven weeks for all patients, and 13 percent were progression-free at six months. Median survival was eight months, with 62 percent and 30 percent of patients alive at six and 12 months, respectively. The company plans to move into pivotal studies early next year. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

• Poniard Pharmaceuticals Inc., of South San Francisco, said results from an interim safety analysis of two Phase I trials of picoplatin, a next-generation platinum in development as a first-line treatment of metastatic colorectal cancer and metastatic hormone-refractory prostate cancer, showed that the drug can be safely administered with fluorouracil and leucovorin in colorectal cancer patients and with docetaxel in prostate cancer patients. Data were presented at the American Society of Clinical Oncology meeting in Chicago. Poniard anticipates beginning Phase II trials in both indications in the third quarter.

• Rational Therapeutics, of Long Beach, Calif., reported clinical results obtained with its laboratory technique, Ex-Vivo Analysis of Programmed Cell Death (EVA-PCD), which accurately identified patients who are candidates for targeted cancer therapy. Data showed that ex vivo laboratory analysis identified non-small-cell lung cancer patients likely to benefit from the EGFr inhibitor Tarceva (erlotinib, OSI Pharmaceuticals Inc. and Genentech Inc.) Findings were presented at the American Society of Clinical Oncology meeting in Chicago.

• Tercica Inc., of Brisbane, Calif., completed enrollment of its MS308 Phase IIIb trial of its approved formulation of Increlex, recombinant human insulin-like growth factor-1, as a once-daily injection in children with primary IGF-1 deficiency. Increlex is marketed in the U.S. for severe primary IGFD using twice-daily injections. The 45-patient trial is testing Increlex given for 34 weeks, with a primary endpoint of height velocity. Data are expected in the second quarter of 2008. Children who complete the first 34 weeks are eligible to continue the study for up to an additional year.

• Thallion Pharmaceuticals Inc., of Montreal, said preliminary data from its Phase I/II trial of ECO-4601 in advanced cancer patients showed that the product was well tolerated in 14 patients during the Phase I portion, with no maximum tolerated dose reached. Each of those patients received from one to eight cycles of treatment, with seven patients completing at least three cycles. The second portion of the study is designed to enroll up to 15 additional patients and will examine further safety and pharmacokinetic data as well as early indications of the compound's efficacy. ECO-4601 is a small molecule derived from a nonpathogenic microorganism that has demonstrated broad in vitro cytotoxic activity across a range of tumor cell lines. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

• Vakzine Projekt Management GmbH, of Hanover, Germany, said results of a recently completed 30-patient Phase I/II study of VPM4001, an immunotherapeutic in cancer, showed that 73 percent of patients suffering from advanced hormone-resistant prostate cancer responded positively to therapy. The primary study parameter, defined as the PSA doubling time, was increased from 63 days to 114 days on average. Those results were presented at the American Society of Clinical Oncology meeting in Chicago.

• Valeant Pharmaceuticals International, of Aliso Viejo, Calif., will initiate a Phase IIa proof-of-concept trial of retigabine in pain associated with postherpetic neuralgia. The study will evaluate the drug's efficacy vs. placebo, with the primary objective measured by a comparison of the average pain intensity during four weeks of maintenance therapy with maximum tolerated doses of retigabine. A total of 180 patients are expected to be enrolled. Retigabine, a neuronal potassium channel opener, is in Phase III development as an adjunctive treatment for partial-onset seizures in patients with refractory epilepsy.

• Ziopharm Oncology Inc., of New York, received FDA clearance to begin a Phase I trial of an oral capsule form of ZIO-101, a small-molecule organic arsenic compound. The study is expected to include patients with advanced solid tumors and will evaluate safety and pharmacokinetics. The injectable form of ZIO-101 is in three Phase II studies in patients with advanced myeloma, liver cancer and hematological malignancies. Separately, the company reported that the name darinaparsin was approved as the non-proprietary name for ZIO-101 and all other forms of that drug.