CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Moves Closer to IND Filing as Manufacturing of Lead Drug Candidate Commences

October 23, 2020 12:11:43
  • Berubicin Expected to Commence Trials for the Treatment of Glioblastoma, An Aggressive Form of Brain Cancer Currently Considered Incurable
  • Production of Berubicin Begins in the U.S. and Europe
  • Dual Manufacturing Facilities Engaged to Reduce Supply Chain Interruptions
  • IND for Berubicin Could Be Filed by Year End

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) expects to have an Investigational New Drug Application (“IND”) ready for its lead drug candidate, Berubicin, by the end of 2020. An approved IND would give the biotech company, which is developing treatments for primary and metastatic cancers of the brain and central nervous system, the green light to go ahead with clinical trials. In June, CNS Pharmaceuticals signed agreements with two manufacturing entities—one in the U.S., the other in Italy—for the production of Berubicin. Three months later, the manufacturing process has commenced, taking the company a step closer to getting an IND approved by the Food and Drug Administration (“FDA”). Berubicin has been specifically developed to target cancers of the brain, including the first targeted indication of glioblastoma multiforme (“GBM”), an aggressive form of brain cancer currently considered incurable. To increase awareness of this destructive disease, a segment on “The Balancing Act, Behind the Mystery,” which airs on Lifetime TV, is focused on glioblastoma. The segment can be viewed here: (click for link).

The manufacturing of Berubicin marks an important milestone on the way to initiating clinical studies on GBM patients. CNS Pharmaceuticals has already completed synthesis of the Berubicin Active Pharmaceutical Ingredient (“API”), which has been shipped to Pii and BSP, manufacturing entities that will prepare an injectable form of Berubicin ready for clinical use. In June, CNSP hired USA-based Pharmaceutics International, Inc. (“Pii”) and Italian BSP Pharmaceuticals S.p.A. (“BSP”) to handle production. With this dual-track approach to manufacturing, the company reduces the risk of failing to meet its clinical timeline due to drug supply. Moreover, situating production in Europe as well as the U.S., provides localized availability of Berubicin for the upcoming Phase I pediatric and Phase II adult studies in Poland and the U.S. Phase II trial.

CNSP has also advanced its clinical agenda. The company recently hired Worldwide Clinical Trials as the contract research organization, Image Analysis Group (“IAG”) as the imaging partner, and Berry Consultants as a biostatistical advisor for its Phase 2 trial design. The company also added Dr. Patrick Wen, a renowned neuro-oncologist, to its Scientific Advisory Board. It has reiterated its expectation to initiate a U.S. Phase 2 trial for Berubicin in Q1 of 2021.

Glioblastoma is one of the most aggressive primary brain cancers in adults, with approximately 13,000 new patients diagnosed each year in the U.S.—the highest diagnosis rate of all malignant brain tumors. Yet, awareness of this pernicious malignancy is sorely lacking, although this may be changing after it struck down a number of well-known figures, including Senators Ted Kennedy and John McCain, as well as Beau Biden, son of Vice-President Joe Biden. However, press reports provide scant details of the affliction, an omission CNSP hopes the broadcast on the Lifetime TV show “The Balancing Act, Behind the Mystery” devoted to glioblastoma will correct. The segment relates the story of a glioblastoma patient, complemented by commentary on the rare and difficult-to-treat disease from Dr. Sigmund Hsu, a member of the Scientific Advisory Board of CNS Pharmaceuticals. Aired on October 12, the segment will be re-broadcast on October 23, 2020.

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