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8-K – Current report

On October 7, 2014 Bio-Path Holdings reported that it has successfully completed Cohort 6 of its Phase I clinical trial evaluating lead compound, Liposomal Grb-2, in blood cancers (Filing 8-K , Bio-Path Holdings, OCT 8, 2014, View Source [SID:1234500808]). Bio-Path now plans to move the compound into Phase II clinical trials.

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Three patients were evaluated in Cohort 6 of the Phase I clinical trial and this cohort was consistent with previous cohorts in demonstrating that Liposomal Grb-2 is safe and well tolerated with the drug showing signs of anti-leukemia activity. As a result of the safety profile of the drug, a maximum tolerated dose has yet to be reached.

A total of 34 patients, of which 21 were evaluable, enrolled into the Phase I clinical trial, which evaluated escalating doses of Liposomal Grb-2 (5, 10, 20, 40, 60 and 90 mg/m2 ). Patients were treated twice a week for four weeks, for a total of eight doses.

Bio-Path is now completing an analysis of the Phase I data to submit to the U.S. Food and Drug Administration (FDA). It expects to begin its Phase II program by the end of 2014. It is anticipated that the first of three Phase II clinical trials will evaluate Liposomal Grb-2 as a combination therapy in Acute Myeloid Leukemia (AML).

"The completion of Cohort 6 is a significant milestone for Bio-Path and moves the Company into its next phase of development with its novel liposomal delivery technology," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "We will now move this program into Phase II while also extending the Phase I portion to continue testing higher doses since we have not yet reached a maximum tolerated dose."

(Press release, Second Genome, OCT 7, 2014, View Source [SID:1234503356])

OXiGENE Announces First Patient Enrolled in Phase 1b/2 Study of Fosbretabulin Combined With Pazopanib in Patients With Advanced Recurrent Ovarian Cancer

On October 7, 2014 OXiGENE reported that the first patient has been enrolled in a Phase 1b/2 clinical study that will evaluate fosbretabulin in combination with Votrient (pazopanib) in patients with recurrent ovarian cancer (Press release OXiGENE, OCT 7, 2014, View Source [SID:1234500802]).

The randomized, controlled clinical study consists of a Phase 1b dose escalation portion with the combination of fosbretabulin and pazopanib and a Phase 2 portion comparing fosbretabulin and pazopanib versus pazopanib alone. The study is estimated to enroll up to 128 patients at sites in the United Kingdom. The primary endpoint is progression-free survival, and secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.

"This study is an important first step to evaluate the potential combination of a vascular disrupting agent (VDA) with an oral anti-angiogenic agent," said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the study. "Recent clinical data suggest that combining fosbretabulin with the anti-angiogenic agent bevacizumab may provide a complementary effect in ovarian cancer patients, and we are hopeful to see a positive result in this new study that would further advance non-chemotherapeutic treatment approaches for patients with relapsed ovarian cancer."

The study is sponsored by The Christie Hospital NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). Fosbretabulin and pazopanib are being provided by OXiGENE and GlaxoSmithKline, respectively.

"The data from this trial will further the body of knowledge about fosbretabulin as part of a non-chemotherapeutic regimen in treating ovarian cancer," said Dai Chaplin, Ph.D., CEO at OXiGENE. "We are delighted to support this important study, along with others, as it provides OXiGENE an important development opportunity in Europe and delivers on our strategy to leverage collaborations that advance the clinical knowledge about fosbretabulin."

Halozyme Announces Issuance Of U.S. Patent For Companion Diagnostic For PEGPH20

On October 7, 2014 Halozyme Therapeutics reported the issuance of U.S. Patent No. 8,846,034 claiming methods for selecting a subject for treatment of a hyaluronan-associated disease with an anti-hyaluronan agent, such as PEGPH20, as well as diagnostic agents for the detection and quantification of hyaluronan in a biological sample in patients (Press release Halozyme, OCT 7, 2014, View Source [SID:1234500800]). Combinations and kits for use in practicing the methods are also provided. PEGPH20 is an investigational PEGylated form of rHuPH20 under development by Halozyme, which degrades the hyaluronan coating that may provide a supportive environment in many solid tumors.

"We are pleased to receive recognition for these biotechnology innovations," commented Dr. Helen Torley, President and CEO. "This companion diagnostic will provide important data for identifying and evaluating those patients and tumors that can benefit most from PEGPH20 therapy."

The issued U.S. patent is anticipated to expire on October 28, 2032, which includes the patent term adjustment. To date, similar claims are pending in eleven countries, as well as the Eurasian and European regions. Additional information about these patents may be found on the U.S. Patent and Trademark Office and on the European Patent Office Web sites.

NeoStem Announces USAN Approval of Generic Name ‘Eltrapuldencel-T’ for Investigational Patient-Specific Targeted Cancer Immunotherapy

On October 6, 2014 NeoStem reported that the United States Adopted Name Council (USAN) has approved the generic name "eltrapuldencel-T" for the Company’s patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma (Press release NeoStem, OCT 6, 2014, View Source [SID:1234500876]). This investigational treatment, planned to be evaluated in the Company’s Phase 3 Intus study, has been granted Orphan Drug, and Fast Track designations by the U.S. Food and Drug Administration and will be conducted under a protocol that has been granted Special Protocol Assessment (SPA). NeoStem plans to begin the trial by the end of 2014.

Eltrapuldencel-T is an autologous immunotherapy intended to eliminate cancer-initiating (stem) cells capable of causing disease recurrence and progression. Creation of the therapy begins with cancer initiating (stem) cells that have been isolated from the patient’s resected tumor sample, enriched and inactivated. These newly created cancer initiating (stem) cells are then combined with dendritic cells (antigen-presenting immune cells) derived from the patient’s own blood, and granulocyte-macrophage colony stimulating factor (GM-CSF, a natural growth factor that stimulates white blood cells in the body). The product is then introduced back into the patient via a series of subcutaneous injections.

"We welcome the receipt from USAN of the generic name for use in this important program and look forward to the launch of our pivotal Phase 3 trial to evaluate eltrapuldencel-T," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

Eltrapuldencel-T was developed by recent NeoStem acquisition California Stem Cell, Inc., based on a technology developed over the course of 10 years at Hoag Memorial Hospital Presbyterian in Newport Beach, California. Two previous Phase 2 clinical studies conducted at Hoag had resulted in a combined median 5-year survival of 50% in patients with Stage IV melanoma, double that of any current treatment.

Following on the success of those trials, the Intus study is a multi-national randomized, double-blind Phase 3 clinical trial in which patients will be randomized in a 2:1 ratio to receive either eltrapuldencel-T or a control treatment (autologous mononuclear cells in GM-CSF). An expected 250 enrolled patients throughout the U.S., Canada, Australia and New Zealand will receive weekly injections for three consecutive weeks, and then once monthly for five months.