Ocular Offers Topline Clinical Data for Second Phase 3 Trial of OTX-DP; Immunomedics to Provide Update on Sacituzumab Govitecan Print E-mail
By William Kent   
Monday, 06 April 2015 19:27
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 6, 2015. 
 
Ocular Therapeutix, Inc., (NASDAQ: OCUL), announced topline data from the Company's second of two Phase 3 clinical trials evaluating the safety and efficacy of its lead product candidate, OTX-DP (Sustained Release Dexamethasone, 0.4mg), for the treatment of ocular inflammation and pain following cataract surgery and reported additional details from the first Phase 3 clinical trial. The two primary efficacy endpoints for the OTX-DP Phase 3 clinical trials were statistically significant differences between the treatment group and the placebo group for the absence of pain on day 8 and absence of inflammatory cells on day 14. Both endpoints need to be met for the trials to be considered successful. In the second Phase 3 clinical trial, OTX-DP met one of the study's two primary efficacy endpoints. In this trial, 77.5% of patients receiving OTX-DP reported an absence of pain in the study eye on day 8 following insertion of the drug product, compared to 58.8% of those receiving placebo vehicle control punctum plug, a difference which was statistically significant (p=0.0025). 39.4% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 31.3% of those receiving placebo vehicle control punctum plug , a difference which was not statistically significant (p=0.2182). Additionally, there were a total of 240 patients enrolled in the second clinical trial, with a 2:1 randomization of treated and control patients.
In March 2015, Ocular Therapeutix reported results from the Company's first Phase 3 clinical trial of OTX-DP, which enrolled 247 patients. In this trial, OTX-DP met both primary efficacy endpoints, achieving a statistically significant improvement in the reduction of inflammatory cells on day 14 and pain on day 8. 33.7% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 14.6% of those receiving placebo vehicle control punctum plug (p=0.0015). In addition, 76.1% of patients receiving OTX-DP reported absence of pain in the study eye on day 8 following insertion of the drug product, compared to 36.1% of those receiving placebo vehicle control punctum plug (p< 0.0001).
Topline safety results have been evaluated for the two Phase 3 clinical trials of OTX-DP. There were no ocular or treatment related serious adverse events in the OTX-DP treatment group in either of the two Phase 3 clinical trials. There were two serious adverse events in the OTX-DP treatment group in the first Phase 3 trial (1.2% incidence), compared with three serious adverse events in the placebo group (3.6% incidence). There were two serious adverse events in the OTX-DP treatment group in the second Phase 3 trial (1.3% incidence), compared with three serious adverse events in the placebo group (3.8% incidence). Overall there were fewer adverse events in the treated group than in the placebo group. The Company expects to be able to use the safety data from these Phase 3 trials to support its other OTX-DP clinical development programs including allergic conjunctivitis.
The secondary efficacy endpoints for the first Phase 3 clinical trial have also been evaluated. Statistically significant differences were seen for the absence of pain at days 2, 4, 14 and 30 in the OTX-DP treatment group compared to the placebo group. Statistically significant differences were seen for the absence of inflammatory cells at day 30 in the OTX-DP treatment group compared to the placebo group, and there were no statistically significant differences seen in the secondary endpoint for absence of inflammatory cells at the other time points in the OTX-DP treatment group in the first Phase 3 trial. Statistically significant differences were seen for the absence of flare at day 8, day 14 and day 30 but not at day 2 or day 4. Data regarding secondary efficacy endpoints for the second Phase 3 trial are still being evaluated.
"Following the favorable results from our first Phase 3 trial, we are disappointed that the second Phase 3 clinical results for resolution of inflammation did not have the same magnitude of differential as what OTX-DP achieved in the first trial," said Amar Sawhney, Ph.D., President and CEO. "Although the efficacy results for the absence of inflammatory cells in the OTX-DP treatment group met our expectations, the placebo group response was significantly higher than expected. We have begun a thorough analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between these two trials that had essentially the same trial design and similar patient populations. We have examined the aggregate result on a post-hoc basis of the absence and very minimal presence of inflammatory cells (defined as 0 and 0.5 on a scale of 0 to 4.0) and the difference between the treatment and placebo groups was found to be highly significant (66.3% in the treatment group and 42.5% in the placebo group, p=0.0004)."
Dr. Sawhney continued, "We plan to meet with the FDA promptly to discuss the Phase 3 OTX-DP clinical trial results and chart the appropriate path forward. The safety data from these two trials further enhances the safety profile of this product and will serve as a foundation for the regulatory submissions for other indications with this product. We look forward to advancing our OTX-DP and OTX-TP clinical development programs to the next stage."
OTX-DP is a product candidate placed in the canaliculus and designed to deliver dexamethasone to the ocular surface for approximately four weeks. Following treatment, OTX-DP resorbs and exits the nasolacrimal system without need for removal. In March 2015, Ocular announced results from its first Phase 3 trial of OTX-DP in post-operative ocular inflammation and pain, which met both its primary efficacy endpoints, with OTX-DP-treated patients achieving a statistically significant improvement in the reduction of inflammatory cells and pain compared to those receiving placebo. In November 2014, the Company announced encouraging data from its Phase 2 clinical trial evaluating the safety and efficacy of OTX-DP in allergic conjunctivitis, and the Company plans to initiate Phase 3 clinical trials for this indication in the middle of 2015. The Company also initiated an exploratory Phase 2 clinical trial of OTX-DP for the treatment of inflammatory dry eye in January 2015. The Company is currently enrolling patients into a Phase 2b clinical trial of its second sustained release product candidate, OTX-TP (Sustained Release Travoprost), for the treatment of glaucoma and ocular hypertension, and this trial is over 70% enrolled. Top-line efficacy data from this trial is expected in the fourth quarter of 2015.
About the OTX-DP Post-Surgical Inflammation and Pain Clinical Trials -- Two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled Phase 3 clinical trials were completed with a total of 487 patients (247 patients in the first Phase 3 trial and 240 patients in the second Phase 3 trial) undergoing unilateral clear corneal cataract surgery. Patients were randomized 2:1 to receive either OTX-DP or a placebo vehicle control punctum plug without active drug. Both primary efficacy endpoints, differences in the proportion of patients in each treatment group with absence of cells in the anterior chamber of the study eye, as measured using slit lamp examination, at day 14 and absence of pain, as graded by a patient-reported score of zero on a scale from zero to ten, at day 8 were recorded at each study visit. Secondary efficacy endpoints were absence of flare in the anterior chamber of the study eye at each evaluation date and absence of inflammatory cells in the anterior chamber of the study eye and absence of pain in the study eye at each evaluation date other than the day used for the primary efficacy measure.
About Post- Surgical Ocular Inflammation and Pain -- Ocular inflammation and pain are common side effects following ophthalmic surgery. Physicians prescribe anti-inflammatory drugs, such as corticosteroids, as the standard of care. If left untreated, inflammation of the eye may result in further ocular complications, including scarring and vision loss. Market Scope estimated approximately 5 million ocular surgeries were to have been performed in the United States in 2014.
  
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Immunomedics, Inc., (Nasdaq:IMMU) today announced that at the upcoming 2015 Annual Meeting of the American Association for Cancer Research (AACR), the Company will provide an update on the multicenter Phase 1/2 study of its lead investigational antibody-drug conjugate (ADC), sacituzumab govitecan, in patients with various solid cancers.
The Company has previously reported meaningful objective response rates, which were determined by computed tomography, in three major indications. Patient populations included triple-negative breast cancer, small cell lung cancer and non-small cell lung cancer. The oral presentation at AACR will include updated results in these three indications, and also the first therapy results in patients with advanced, heavily-pretreated colorectal and esophageal cancers.
Dr. Alexander N. Starodub of Indiana University Health Center for Cancer Care, Goshen, Indiana, one of the Principal Investigators of the multicenter study, will present the updated results. The oral presentation, entitled: "Advanced Solid Cancer Therapy with a Novel Antibody-Drug Conjugate (ADC), Sacituzumab Govitecan (IMMU-132): Key Preclinical and Clinical Results," is scheduled for Monday, April 20, 2015 at 3:10 PM – 3:30 PM in Room 103 of the Pennsylvania Convention Center.
Also Monday:
 
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that it is entering into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group (RTOG) Foundation to evaluate the safety and efficacy of Advaxis's lead cancer immunotherapy, ADXS-HPV (ADXS11-001), in a pivotal Phase 2/3 anal cancer trial, which will be run by NRG Oncology. ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene.
Avinger, Inc., (Nasdaq:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that John Borrell has been named Vice President of Sales, effective April 20, 2015. 
Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of revolutionary bone grafts, is pleased to announce that the United States Patent and Trademark Office has issued US Patent No. 8,992,964 entitled "Process for Demineralization of Bone Matrix with Preservation of Natural Growth Factors." 
Capnia, Inc. (Nasdaq:CAPN), focused on the development of novel products based on its proprietary technologies for precision metering of gas flow, today announced it has been awarded a Small Business Innovation Research (SBIR) Phase I grant totaling approximately $220,000 by the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH). 
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced the initiation of a Phase 1/2 safety pilot and expansion study examining the investigational combination of varlilumab and ipilimumab (Yervoy®; Bristol-Myers Squibb) in patients with Stage III or IV metastatic melanoma. Varlilumab is Celldex's fully human monoclonal antibody that targets CD27, a critical co-stimulatory molecule in the immune activation cascade. Ipilimumab, a recombinant, human monoclonal antibody that blocks CTLA-4, is FDA approved for the treatment of unresectable or metastatic melanoma. 
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that data from the Phase 2 EMERGE study of glembatumumab vedotin in metastatic breast cancer have been published in the Journal of Clinical Oncology.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced that its GMP laboratory and production facility in Shanghai has successfully passed a fourth consecutive China Food and Drug Administration (CFDA) inspection.
Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead proprietary drug candidate, CUDC-907 for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL).
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases, today announced the completion of its previously announced underwritten public offering of 1,200,000 shares of its common stock. 
Juno Therapeutics, Inc. (Nasdaq:JUNO) today announced that it entered into a settlement agreement to resolve litigation with the Trustees of the University of Pennsylvania ("Penn") and Novartis Pharmaceuticals Corporation ("Novartis"). Juno became a party to the litigation after it entered into a December 2013 license agreement with St. Jude Children's Research Hospital ("St. Jude"), also a party in the litigation, for patent rights owned by St. Jude.
Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced articles being published in the current issue of Science, one article by the Company's Cooperative Research and Development Agreement (CRADA) collaborators at the National Cancer Institute (NCI) and the second article by the Netherlands Cancer Institute (NKI). 
NeoStem, Inc. (Nasdaq:NBS), a biopharmaceutical company developing novel cell-based personalized medicine therapies, announced today that the Company's management and experts will present at multiple conference in April.
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize heat therapy to treat cancer, today announced the appointment of Brian A, Meltzer, M.D. as Chief Medical Officer and Vice President of Business Development, effective April 1, 2015. 
Phibro Animal Health Corporation (Nasdaq:PAHC) Chairman, President and Chief Executive Officer Jack Bendheim and Chief Financial Officer Richard Johnson will address financial analysts and investors at the Bank of America Merrill Lynch 2015 Health Care Conference.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the European Medicines Agency (EMA) has informed the Company, through Repros' wholly owned subsidiary, that its enclomiphene citrate capsules are eligible for submission for a centralized marketing authorization application (MAA) as a New Active Substance. 
RestorGenex Corporation (OTCQB:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, reported on its cash balance as of December 31, 2014 and its financial results for the year ended December 31, 2014. 
Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, today announced its wholly owned Quad Video Halo, Inc. subsidiary will be exhibiting its latest version of its proprietary Quad Video Halo 3.0™ System ("QVH") at the 2015 American Society of Interventional Pain Physicians (ASIPP) Annual Meeting in Orlando, Florida, April 9-11. 
VBI Vaccines Inc. (Nasdaq:VBIV) announced today that it has entered into a research collaboration with Sanofi Pasteur to apply VBI's LPV™ (Lipid Particle Vaccine) formulation technology to further the development of a key Sanofi Pasteur vaccine candidate.



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