SpineThera Receives $2 Million Grant From U.S. Army

SpineThera, Inc., a privately held pharmaceutical company, announced today that the United States Army has awarded the company a grant to support the further development of SX600, a sustained-release, injectable, micro-suspension corticosteroid in development to address the unique requirements of an epidural injection to treat back pain.

Back pain is a significant medical problem for the Armed Forces resulting in evacuations, treatments, and training of replacement personnel. Prevalence among deployed personnel is 21-27%, and it is the most common condition for which medical treatment is sought in the military.

Jeff Missling, Founder and CEO of SpineThera, stated, “We are honored and thankful to receive this $2,019,442 award from the United States Army. Army doctors have shown that treating back pain in forward deployed pain clinics results in return-to-duty rates greater than 90%, but have also reported that 35% of coalition forces who received an epidural steroid injection for back pain returned to these forward deployed pain clinics for another injection. The typical interval between injections was 2-4 weeks. Our goal with SX600 is to offer a long-acting injectable drug that provides pain relief and reduces the need for repeat or frequent epidural steroid injections. Knowing that our drug has potential benefits to deployed military personnel, in addition to non-deployed military personnel and the general patient population, adds further meaning to our work. We aim to offer back pain patients a better treatment option than exists today.”

About the Award:

The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Broad Agency Announcement under Award No. W81XWH-17-1-0014. Opinions, interpretations, conclusions and recommendations are those of the SpineThera and are not necessarily endorsed by the Department of Defense. In conducting research using animals, SpineThera adheres to the laws of the United States and regulations of the Department of Agriculture.

About SpineThera:

SpineThera designs and develops sustained-release, injectable drugs to meet the unique safety requirements for administration in and near the spine. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs. SX600 is an investigational drug.

SpineThera’s Second U.S. Patent to Issue 21 Feb 2017

SpineThera, a privately held, pre-clinical stage pharmaceutical company, announced today that the United States Patent and Trade Mark Office has provided official notice that US Patent 9,572,771 covering sustained-release, injectable drug formulations for the treatment of back pain will issue on 21 Feb 2017.   

“This second patent strengthens the protection of our lead drug, SX600, a sustained-release, injectable, micro-suspension corticosteroid that we have developed to address the unique requirements of an epidural injection to treat back pain,” said Jeff Missling, Founder and CEO of SpineThera. “We are continuing to pursue rapid development of SX600 as we know that 4 million patients receive an epidural steroid injection every year in the United States for back pain despite there being no FDA approved drug for this use.  We aim to replace those off-label epidural steroid injections with SX600 and to improve the duration of pain relief from a single epidural injection.”

SpineThera had previously announced in October 2016 that the United States Patent and Trademark Office had issued a Notice of Allowance for U.S. Patent Application Serial Number 14/561,797. SpineThera has now received an Issue Notification for this application stating that it will issue on 21 Feb 2017 as US Patent 9,572,771.

About SpineThera:

SpineThera designs and develops sustained-release, injectable drugs to meet the unique safety requirements for administration in and near the spine. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs.

SpineThera Announces Allowance of Patent

SpineThera Inc., a privately held pharmaceutical company, announced today that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/561,797.  Jeff Missling, CEO, commented, “This new patent builds on our previously issued patent and furthers our intellectual property protection of our sustained-release, injectable micro-suspension technology, including our lead drug product candidate.”  SpineThera expects the patent to be issued within the next few months.

 About SpineThera:

SpineThera designs and develops sustained-release, injectable drugs to meet the unique safety requirements for administration in and near the spine. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs.

SpineThera Featured at BIO - NIH SBIR Innovation Zone

SpineThera, a privately held, pre-clinical stage pharmaceutical company, has been selected to participate in the National Institutes of Health SBIR Innovation Zone at the BIO International convention to be held in San Francisco, June 6-9, 2016.

About BIO: As the world's largest biotechnology conference and exhibition, this annual event attracts 15,000 biotech leaders from 65 countries and covers the wide spectrum of life science innovations and application areas including drug discovery, bio manufacturing, genomics, biofuels, nanotechnology, cell therapy, and more.

About the BIO Innovation Zone: The NIH and NSF have continued their partnership with BIO, where nearly 100 of the most promising SBIR/STTR grantees will showcase and discuss their technologies in the exciting Innovation Zone, a premier partnering opportunity, at the BIO International Convention on June 6-9, 2016, in San Francisco, CA.

Mr. Jeff Missling, CEO of SpineThera said, "We are grateful for the support of NIH who previously funded our Phase 1 SBIR grant and now is providing this opportunity to be featured at BIO 2016. Emily Meyering, our Director of R&D, and I are looking forward to telling SpineThera's story at BIO and welcome invitations for 1:1 meetings with interested parties."

Foster and Wood Join Board of Directors

SpineThera, a privately held, pre-clinical stage pharmaceutical company, announced that John Foster and David Wood have joined its Board of Directors.

Mr. Foster previously led CNS Therapeutics through development of a 505(b)2 pain drug for site-specific administration to the central nervous system to treat intractable chronic pain. CNS was acquired by Mallinckrodt. He is currently the CEO and Chairman of NTF Therapeutics and Vice Chairman of Gillette Children's Specialty Healthcare. Jeff Missling, Chairman and CEO of SpineThera, said, "John's success in commercializing injectable drugs is directly relevant to SpineThera. He brings strong knowledge of clinical, commercial, and regulatory processes to our Board." 

Mr. Wood previously led Spinal Modulation through commercialization of a novel, implantable neuro-stimulator designed to treat intractable neuropathic pain. Spinal Modulation was acquired by St. Jude Medical. John was previously the COO of CardioNet and VP and General Manager of the Drug Delivery Business Unit at SurModics. Mr. Missling said, "Dave has excellent relationships with leading Interventional Pain physicians in the United States and abroad. He is above all a strategist with a keen focus on speed and execution." 

Foster and Wood join Mr. Jerry Jerome and Mr. Wayne Kelly on SpineThera's Board. Missling commented, "I am delighted and grateful to have John and Dave join SpineThera's Board. They both have a track record of raising significant capital from venture firms and strategic partners, and of leading a start-up through the acquisition process. In addition, they bring relevant experience from pain medicine product development. They undoubtedly strengthen SpineThera's board and position us for longer term success."

Biotech Showcase: SX600 Presentation

SpineThera, a privately held, pre-clinical stage pharmaceutical company, announced that Jeff Missling, CEO, will give a company presentation at the BioTech Showcase in San Francisco, CA on Tuesday, 12 Jan 2016 at 4:15 pm. Missling said, "Meeting participants can expect to learn more about our patented micro-suspension, sustained-release corticosteroid technology at this presentation. Our lead product candidate, SX600, is a 505(b)2 drug in development for epidural administration. Physicians routinely administer epidural injections of relatively short-acting generic steroids to treat lumbosacral radiculopathy and other back pain conditions. We aim to develop improved drugs for this underserved market."

Presentation Details:

Parc 55 Hotel, 55 Cyril Magnin Street, San Francisco, California, USA, 94102

12 Jan 2016, 4:15 pm; Track E-Davidson (4ths Floor)

Attend BioTech 2016

Closing of Series B-2 Stock Offering

SpineThera, a privately held, pre-clinical stage pharmaceutical company, announced the closing of a $2.81M preferred stock offering. SpineThera Founder and CEO, Jeff Missling, said, "With support from both existing and new investors, I am pleased to announce the closing of our Series B-2 stock offering. Raising this additional capital will enable us to aggressively pursue further development of our patented micro-suspension, sustained-release corticosteroid for epidural administration to treat back pain."

Lieutenant Governor Hosts Angel Investor Tax Credit Roundtable at SpineThera, Inc.

Founder and CEO Jeff Missling, along with 5 other Minnesota life science start-ups, participated. During the roundtable, Missling shared his experience with the Lt. Governor, stating "50% of the capital SpineThera has raised came from outside the state of Minnesota, including 5 states and 2 countries. All of our investors have participated in the Angel Tax Credit program, and it resulted in a net import of capital to Minnesota."

Read the full article here.