• Allos Therapeutics Inc., of Westminster, Colo., reported that interim analysis of patient response data from a pivotal Phase II study of PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma exceeded the prespecified threshold for continuation of the trial. The independent data monitoring committee completed an interim analysis of the safety data from the first 35 evaluable patients and recommended that the trial continue. No major safety concerns were identified. The DMC is expected to conduct another interim analysis of safety data from the first 65 evaluable patients, and that safety analysis is expected by the end of 2007. Allos said it expects to complete enrollment in the trial, known as Pralatrexate in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma, or PROPEL, in the second quarter of 2008.

• Alseres Pharmaceuticals Inc., of Hopkinton, Mass., said the independent data safety monitoring board has unanimously authorized expanding the company's Phase I/IIa clinical trial in acute spinal cord injury (SCI) to allow subjects with cervical SCI to be treated with a 9-mg dose of Cethrin. The recommendation is based on the safety analyses of data from thoracic subjects who have been treated at the 9-mg dosage level and overall evaluation of safety of the drug in the clinical trial to date. Cethrin is a recombinant protein intended to facilitate the re-growth of axons during the critical period immediately after a major trauma to the spinal cord.

• Cell Therapeutics Inc., of Seattle, said it began a confirmatory Phase III trial of combination chemotherapy for women with advanced non-small-cell lung cancer. The PGT307 trial, exclusively in women with premenopausal estrogen levels, will evaluate Xyotax (paclitaxel poliglumex) in combination with carboplatin vs. paclitaxel/carboplatin. The company also said it received special protocol assessment approval from the FDA on the design of the trial. The trial is expected to enroll 450 patients who will receive either regimen once every three weeks. Patients will be treated for up to six cycles. The primary endpoint is superior overall survival, with secondary endpoints including progression-free survival, disease control, clinical benefit, response rate, quality of life and safety and tolerability. CTI said it plans to submit a marketing authorization application in Europe in the first half of 2008 for Xyotax as a single agent for first-line treatment of NSCLC in performance status 2 patients, based on results from its Stellar 4 Phase III trial.

• Chelsea Therapeutics International Inc., of Charlotte, N.C., said it plans to begin patient dosing in the fourth quarter for Phase III trials of Droxidopa in neurogenic orthostatic hypotension (NOH). The plan for two pivotal trials evaluating a total of up to 236 patients followed a meeting on trial design with the FDA in August. Both pivotal efficacy trials (Studies 301 and 302) will have a primary endpoint of improvement in dizziness as measured by an orthostatic hypotension symptom assessment scale. The trials are expected to include about 30 U.S. sites and 20 European sites. Symptomatic NOH is a neurogenic disorder resulting from a deficient release of norepinephrine. Droxidopa is an orally active synthetic precursor of norepinephrine designed to increase the supply of norepinephrine. The product has been approved in Japan since 1989.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, said researchers reported that the firm's lead compound Ceflatonin showed clinical activity against Gleevec-resistant, accelerated phase chronic myeloid leukemia (CML) associated with T315I BCR-ABL kinase domain mutation. The firm reported positive clinical outcomes for two CML patients with the T315I BCR-ABL kinase domain mutation, one of whom was treated with Ceflatonin, the other was treated with interferon-alpha. The T315I BCR-ABL mutation results in resistance to tyrosine kinase inhibitor drugs, including Gleevec (imatinib mesylate), Sprycel (dasatinib) and Tasigna (nilotinib) that are currently used to treat CML patients. The patient treated with Ceflatonin experienced a 30 percent reduction of T315I BCR-ABL levels within one month of the initiation of treatment and a complete hematological response after five months.

• CytRx Corp., of Los Angeles, said it will initiate a Phase IIb efficacy trial late this year of its orally administered molecular chaperone-based drug candidate arimoclomol in patients with amyotrophic lateral sclerosis (ALS). The study is a double-blind, placebo-controlled trial and is expected to include 390 ALS patients enrolled at 30 to 40 clinical sites in the U.S. and Canada. Two-thirds of enrolled patients will receive 400 mg of arimoclomol in capsule form three times daily, and the remaining patients will receive placebo administered three times daily. The Phase IIb trial's primary endpoint will be efficacy at nine months. The firm expects to report primary endpoint data about 18 months following the initiation of patient enrollment. CytRx also is continuing to initiate a Phase II clinical trial with arimoclomol in recovering stroke volunteers in the first half of 2008, subject to FDA clearance. The firm said it also plans to initiate a Phase II study in the first half of 2008 of its oral compound iroxanadine in patients with diabetic foot ulcers.

• Encysive Pharmaceuticals Inc., of Houston, said it will move forward with plans to conduct an additional Phase III study evaluating Thelin (sitaxsentan sodium) in patients with pulmonary arterial hypertension. The company has been discussing possible protocols for the trial, to be called STRIDE 5, with its scientific advisory board and other experts. It now plans to work with the FDA to finalize the protocol. The company in June received an approvable letter on its new drug application filing with the FDA, which called for additional study before the product could be approved. As a result of its decision to conduct an additional trial, Encysive said it no longer would pursue the formal dispute resolution process with the FDA over the approvable letter. (See BioWorld Today, June 19, 2007.)

• F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said data from the Phase IV First BEAT trial showed complete removal of metastatic lesions was achieved in almost 80 percent of patients treated with Avastin plus standard chemotherapy for their colorectal cancer. Almost all the patients had been considered inoperable prior to the start of treatment, Roche said, adding that the outcome with Avastin was higher than had been seen previously in trials with other biologics/chemotherapy combinations. The First BEAT trial included 1,965 patients in 41 countries with advanced colorectal cancer, with primarily inoperable metastatic disease. Data were presented at the European Cancer Conference in Barcelona, Spain. Genentech Inc., of South San Francisco, is Roche's partner for Avastin (bevacizumab).

• Knopp Neurosciences Inc., of Pittsburgh, started a Phase I trial with KNS-760704, a small-molecule therapy for treatment of amyotrophic lateral sclerosis. The randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers will be followed closely by a multiple ascending dose study in healthy subjects. Both are designed to evaluate the safety, tolerability and pharmacokinetics of KNS-760704 in humans.

• NitroMed Inc., of Lexington, Mass., said a study showed that two different combinations of individual isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD), used in the Vasodilator-Heart Failure Trials I and II, are not bioequivalent to BiDil, the fixed-dose combination of ISDN and HYD used in the company's African-American heart failure trial. The nonbioequivalence in the formulations used may explain why V-HeFT I, V-HeFT II and A-HeFT had very different results in reducing mortality and morbidity, NitroMed said. Results of the study were published in the current edition of Clinical Pharmacokinetics. Earlier, NitroMed said reimbursement and formulary status of BiDil continues to improve, with about 80 percent of African-Americans who have commercial and government prescription drug insurance coverage in the U.S. having affordable access to the product.

• Pacgen Biopharmaceuticals Corp., of Vancouver, British Columbia, said it plans to initiate a Phase IIb dose-ranging clinical trial by the end of this year of an optimized formulation of its compound PAC-113, a novel treatment for oral Candidiasis infection. The study will be a randomized, examiner-blinded, parallel design trial comparing three different doses of PAC-113 to nystatin, a topical mouth rinse treatment for oral Candidiasis. The study, expected to be completed in the second quarter of 2008, will enroll about 200 seropositive HIV patients with oral Candidiasis in multiple sites in the U.S. and South Africa. A Phase I/II study showed the PAC-113 treated group had a complete clinical cure rate of 44 percent, compared to the protocol nystatin treated group at 40 percent.

• Prana Biotechnology Ltd., of Melbourne, Australia, said it has completed patient enrollment in its Phase IIa clinical trial of PBT2 in patients with early Alzheimer's disease. The Phase IIa trial is a double-blind, placebo-controlled study exploring the safety and tolerability of PBT2 and its effects on the mechanism and progression of the disease by investigating biomarkers of Alzheimer's disease as well as measures of cognition. Prana will complete dosing of the last patient by the end of 2007, and is on track to deliver results in the first quarter of 2008. PBT2 is the firm's first lead compound to be selected from the its proprietary drug library of Metal Protein Attenuating Compounds, which have a unique mechanism of action that may be useful against a range of neurodegenerative conditions.

• PrimeCell Therapeutics LLC, of Irvine, Calif., said results of a clinical study involving the implantation of autologous adult bone-marrow stem cells into 38 patients with spinal cord injuries revealed that some patients experienced restored function. PrimeCell provided research support and preclinical studies as part of the clinical trial program, which was conducted at Luis Vernaza Hospital in Guayaquil, Ecuador. The autologous bone marrow stem cells - cells extracted from the patients' own bone marrow - were taken from the patients' hip bone. Of the 25 patients of whom follow-up data were collected for at least three months and up to 14 months, 15 gained the ability to stand, 10 walked on parallels with braces, seven walked without braces and five walked with crutches. Three of the patients recovered full bladder control and 10 regained some form of sexual function. No adverse events or abnormal reactions to implantation were observed.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said a Phase II trial of PI-88 in combination with docetaxel in patients with advanced non-small-cell lung cancer did not meet its primary endpoint of significantly improving the progression-free rate at six months compared to docetaxel alone. The trial also did not meet its secondary endpoints of improvement in time to progression, response rates, overall survival and quality of life. The company said the result has no impact on its Phase III registration strategy for patients with post-resection liver cancer, which it said Monday was granted fast-track status by the FDA. That trial in 600 patients will evaluate disease-free survival and whether PI-88 can prevent early recurrence following curative hepatic surgery. That study is expected to begin later this year. PI-88, a heparan sulfate mimetic, is designed to inhibit both angiogenesis and metastasis. Progen's stock (NASDAQ:PGLA) fell 18 cents Monday to close at $2.83.