Moleculin Requests Authorization from the Polish Government

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
446
Moleculin Requests Authorization from the Polish Government to Advance Annamycin

HOUSTON, TX --(Marketwired - October 24, 2017) - Moleculin Biotech, Inc., ( NASDAQ : MBRX ) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that has submitted its request for Clinical Trial Authorization ("CTA") in Poland which, if allowed, will enable a clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") in Poland. This will be in addition to the previously announced allowance of its Investigative New Drug filing with the Food & Drug Administration in the US.

"Consistent with our prior guidance, we have now taken the final step required to expand our Annamycin clinical trial to Poland," commented Walter Klemp, Chairman and CEO of Moleculin. "Unlike the US, the process for beginning a clinical trial in Poland requires a hospital contract before a request for CTA can be made. We recently announced the required hospital contract and this announcement now marks the formal request for Polish approval."

Mr. Klemp continued: "The CTA request process in Poland normally takes 60 days, so we hope to be enrolling patients there near year-end. Increasing the breadth of clinical trial sites beyond the US will give Moleculin access to more potential patients, and, hopefully, speed the Phase IIa portion of the trial."

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com .

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to demonstrate safety and efficacy in cancer patients and the ability of Moleculin to receive approval to conduct clinical trials in Poland. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts Joe Dorame, Robert Blum or Joe Diaz Lytham Partners, LLC 602-889-9700 mbrx@lythampartners.com

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Medicare Competitive Bidding May Slash Jobs, Access

Updated Category News Views 4

Medicare's New Program: Potential Knockout Punch? Today, we dive into Medicare's latest shake-up that might just be the unseen wrecking ball swinging toward thousands of jobs and small businesses in the healthcare sector. Two years from now, starting January 2028, the Competitive Bidding Program is set to reroute the entire landscape for suppliers of key medical products...

Continue Reading
Lyric Health's AI System Promises Data-Driven Revolution

Updated Category News Views 4

A Bold Step in Healthcare Coordination No doubt about it, healthcare is a mess. It's like trying to patch a leaking ship with duct tape—point solutions here, add-ons there, and nothing truly working in harmony. And in storms in Lyric Health, claiming they've got the answer. They've launched an AI-powered Healthcare Operating System meant to unify these disjointed pieces...

Continue Reading
Finastra Recognized as 2026 Leader in Payment Platforms

Updated Category News Views 4

Finastra Steals the Spotlight in Payments Innovation When it comes to the modern world of finance, nothing screams ‘adapt or fade into oblivion’ like the payments industry. Well, here’s a reality check from QKS Group: Finastra has snatched the spotlight in their SPARK Matrix™ for 2026 as a powerhouse in integrated bank payments platforms. Clearly, this ain’t...

Continue Reading
B2B Growth Hinges on Narrative Coherence, Study Shows

Updated Category News Views 5

Clear Stories, Stronger Growth If companies can't tell a clear story that their buyers understand and believe, they're destined to stagnate. That's the blunt reality kompeld is pushing with their H2 2026 Narrative Coherence Benchmark. The report scores 150 B2B tech companies on their narrative coherence, showing there's a stark correlation between storytelling and growth....

Continue Reading
ScholarShare 529 Launches $50 Back-to-School Promo

Updated Category News Views 5

California Families Get a Boost With New 529 Plan Offer Everywhere you turn, it's 'back to school' mania right now, and ScholarShare 529 aims to ride that wave by sweetening the pot for parents ready to think ahead. So here's the gist—California's official college savings plan is handing out a $50 gift card for new accounts opened between now and September 30th. Setting...

Continue Reading
OrthoAtlanta Expands with Dr. Smith's Expertise Hire

Updated Category News Views 4

OrthoAtlanta Welcomes New Orthopedic Surgeon In a world where healthcare organizations are constantly stretching their wings, this new addition of Dr. Carson J. Smith to the fold at Piedmont Orthopedics | OrthoAtlanta stands out. This isn't just some cosmetic face-lift, folks. It's a real investment in the community, not to mention a crucial broadening of what this...

Continue Reading
Jacob Walthour to Be Honored for Economic Leadership

Updated Category News Views 5

The Honoring of Leadership That Goes Beyond Business In a world where financial influence often feels like it funnels into the same familiar pockets, the news of Jacob Walthour Jr.'s upcoming recognition feels like a fresh breeze of change. The Alpha Phi Alpha's Alpha Alpha Lambda Chapter is rolling out the red carpet at its Centennial Gala for Walthour, throwing him into...

Continue Reading
2026 CEE Awards Highlight Energy Innovation Leaders

Updated Category News Views 6

Showcasing Cutting-Edge Home Energy Innovations It's that time of year again when the brightest innovators in home energy solutions get a nod from the Consortium for Energy Efficiency (CEE). This year's Integrated Home Competition spotlighted five trailblazing products that promise to reshape how we think about energy efficiency, demand flexibility, and sheer user comfort...

Continue Reading
Koogler's Sale to ALL4: A Game-Changer for the Southeast

Updated Category News Views 5

A Strategic Alignment Unfolds in Environmental Engineering Ever notice how those industry shifts often sneak up on you, only to leave a mark that's hard to ignore? That's exactly what's playing out with Koogler & Associates' recent hookup with ALL4 LLC. Set aside that coffee, this one's too important to miss if you've got a stake in the environmental consulting game or...

Continue Reading
American Savings Bank IPO Hits NYSE: $129M Raised

Updated Category News Views 6

A Big Day for American Savings Bank Buckled up yet? Because American Savings Bank has just shot onto the NYSE, raising a hefty $129 million. A solid start, I’d say, for a Honolulu-based outfit that now struts around with a valuation tipping beyond $1.03 billion. That’s what you get when you price more than eight million shares at $16 a pop. NYSE:ASBH is the new kid on...

Continue Reading

Top 5 Most Recently Viewed Articles

Houlihan Lokey Reaches New Peak with $162.91 Stock Value

Updated Category News Views 145

Houlihan Lokey Achieves All-Time High Recently, shares of Houlihan Lokey (NYSE:HLI) Inc reached an impressive all-time high of $162.91. This milestone is indicative of the strong market confidence and positive investor sentiment surrounding the global investment bank. The stock has experienced remarkable growth, rising by 50.22% within the last year, largely driven by the...

Continue Reading
Mister Car Wash Transitioning Stock Listing to Nasdaq Markets

Updated Category News Views 113

Mister Car Wash Transitioning to Nasdaq Mister Car Wash, Inc. (NYSE: MCW), recognized as the largest car wash brand in the nation, is making a significant move in the financial market. The company has announced its intention to voluntarily transfer its common stock listing from the New York Stock Exchange to the Nasdaq Global Select Market. This transition is set to occur...

Continue Reading
Polaris Inc. Announces Upcoming Earnings Call for 2024

Updated Category News Views 201

Polaris Inc. Earnings Conference Call Announcement Polaris Inc. (NYSE: PII) has exciting news to share regarding their financial reporting schedule. The company is set to release its fourth quarter and full year 2024 financial results soon. This report will be made available on the company’s official website, providing insights into their performance over the past year....

Continue Reading
Charmaine Carmichael Joins Trifork as COO and UK Director

Updated Category News Views 426

Trifork Welcomes Charmaine Carmichael Trifork, a leading technology innovation partner, has recently made an exciting announcement regarding its leadership structure. The company has appointed Charmaine Carmichael to the newly created position of Group Chief Operating Officer (COO) and Director of Trifork UK. This strategic move aims to reinforce their commitment to...

Continue Reading
Duchesnay Pharmaceutical Group Achieves 2025 Healthiest Workplace

Updated Category News Views 209

Duchesnay Pharmaceutical Group Achieves Prestigious Recognition Duchesnay Pharmaceutical Group (DPG) has recently been awarded the 2025 Healthiest Workplace Award by Dialogue Health Technologies Inc. This accolade marks a significant achievement for DPG, showcasing the company's unwavering commitment to the well-being of its employees. Known for its innovative approaches...

Continue Reading