|By Marketwired .||
|May 30, 2014 08:05 AM EDT||
DURHAM, NC -- (Marketwired) -- 05/30/14 -- Heat Biologics, Inc. (NASDAQ: HTBX), a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, announced today that its Dose Escalation Committee has approved the expansion of the first cohort to full enrollment in its ongoing Phase 1/2 study of HS-410 (Vesigenpumatucel-L) for the treatment of bladder cancer. The Committee unanimously agreed to expand the cohort to the full nine patients without delay.
The decision was based on pre-specified protocol criteria and was made after the initial three patients were dosed with Heat Biologic's off-the-shelf product candidate designed to activate a T-cell mediated pan-antigen immune response for the treatment of non-muscle invasive bladder cancer.
There were no serious adverse events reported in the initial three patients, and all non-serious adverse events and injection site reactions reported were Grade 1.
"We are delighted about the early reports of the safety of HS-410," said Jeff Wolf, CEO of Heat. "This early data appears to be consistent with the data from our successful Phase 1 lung cancer trial with our product candidate HS-110 (Viagenpumatucel-L) based on the same ImPACT platform."
The multi-center Phase 1/2 bladder cancer study of HS-410 (Vesigenpumatucel-L) will enroll approximately 93 patients after transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG). The Phase 1 portion of the trial is designed to evaluate the safety of two doses of HS-410 in bladder cancer patients. In the Phase 2 portion, the trial is designed to evaluate whether vaccination with HS-410 extends the time to disease recurrence compared to placebo.
Heat's proprietary Immune Pan Antigen Cytotoxic Therapy ("ImPACT") reprograms live cancer cells from a single tumor source to continually secrete gp96, a chaperone protein found in all human cells. In turn, gp96 chaperones tumor antigens to T-cells to activate a robust, pan-antigen T-cell immune response and direct killer T-cells to attack the patient's cancer. Heat's ImPACT technology holds promise for treating a wide variety of different cancers.
According to the American Cancer Society, in 2012, there were 73,000 new cases of bladder cancer reported and 15,000 deaths from the disease in the U.S. alone. More than 500,000 people in the U.S. have been treated for bladder cancer. Importantly, the U.S. Food and Drug Administration "FDA" has not approved any new drugs to treat bladder cancer in more than 25 years. Heat's HS-410 (Vesigenpumatucel-L) represents a viable opportunity to address a significant unmet medical need.
About Heat Biologics, Inc.
Heat Biologics, Inc. (www.heatbio.com) is a clinical-stage biopharmaceutical company focused on developing its novel, "off-the-shelf" ImPACT therapeutic vaccines to combat a wide range of cancers. Our ImPACT Therapy is designed to deliver live, genetically-modified, irradiated human cells which are reprogrammed to "pump out" a broad spectrum of cancer-associated antigens together with a potent immune adjuvant called "gp96" to educate and activate a cancer patient's immune system to recognize and kill cancerous cells. Heat's Viagenpumatucel-L (HS-110) will be entering Phase 2 trials against non-small cell lung cancer and its Vesigenpumatucel-L (HS-410) is being evaluated in an ongoing Phase 1/2 clinical trial against bladder cancer.
Forward Looking Statements
This press release includes forward-looking statements on our current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and include statements regarding the potential for Heat's ImPACT Therapy. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability for Heat's ImPACT Therapy to perform as designed and ability to enroll patients as planned. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Mar. 29, 2017 03:30 AM EDT Reads: 3,311
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
Mar. 29, 2017 03:30 AM EDT Reads: 3,180
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Mar. 29, 2017 03:30 AM EDT Reads: 11,696
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
Mar. 29, 2017 03:30 AM EDT Reads: 3,195
Mar. 29, 2017 03:00 AM EDT Reads: 6,048
Mar. 29, 2017 01:45 AM EDT Reads: 5,391
Mar. 29, 2017 01:15 AM EDT Reads: 2,466
Mar. 29, 2017 01:15 AM EDT Reads: 9,171
Mar. 29, 2017 01:00 AM EDT Reads: 1,087
Mar. 29, 2017 12:15 AM EDT Reads: 1,372
Mar. 29, 2017 12:15 AM EDT Reads: 8,461
Mar. 28, 2017 11:15 PM EDT Reads: 3,455
Mar. 28, 2017 09:30 PM EDT Reads: 3,736
Mar. 28, 2017 09:30 PM EDT Reads: 3,838
Mar. 28, 2017 09:30 PM EDT Reads: 2,226