CytRx Announces Clinical Hold Lift By FDA Print E-mail
By M.E.Garza   
Wednesday, 02 December 2009 08:43
As anticipated and reported by BioMedReports on Novermber 23rd, CytRx Corporation (NASDAQ:CYTR) appears to be shaping up into quite a rebound story. This morning, officials at the company have announced that they are permitted to re-enter the clinic with its orally administered molecular chaperone drug candidate arimoclomol as a therapeutic treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), following the U.S. Food and Drug Administration’s (FDA) acceptance of a revised clinical trial protocol.

“We are delighted with the FDA’s decision to approve a protocol that provides a safe and efficient avenue to ascend arimoclomol dosing to the target dosage level of 400 mg three times daily, which we believe will prove most effective in treating ALS patients,” said CytRx President and CEO Steven A. Kriegsman. “Arimoclomol’s underlying molecular chaperone amplification method of action has shown promising clinical and preclinical study results in inhibiting the progression of ALS, a debilitating disease that currently lacks effective therapeutic treatment. We believe that this drug candidate has the potential to be a breakthrough drug with application in a number of other neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and Huntington’s disease, and as a treatment for stroke recovery and neuropathy. Recent independent findings also indicate that molecular chaperone technology represents a significant strategy in the future design of anti-aging pharmaceuticals.

“We have attracted significant interest from several pharmaceutical companies as potential partners to advance development of our molecular chaperone programs, and we view clearance to resume arimoclomol clinical testing as a key step in moving these negotiations forward. Given the significant opportunity arimoclomol presents in ALS, we are prepared to resume the clinical trial in parallel with our discussions,” he added.

CytRx Chief Medical Officer Daniel J. Levitt, M.D., Ph.D., said in a prepared statement that, “The revised protocol allows for a safety assessment and a preliminary efficacy evaluation in ALS patients treated with arimoclomol at levels up to four times the dose administered in our prior Phase IIa clinical trial and open label extension study. Arimoclomol will be administered in combination with riluzole (Rilutek®), the only currently FDA-approved treatment for ALS, which typically prolongs life by approximately two months. We currently estimate that data from this trial, should all tiers be completed, will be available approximately 18 months from the time the trial starts.”

We have been anticipating good news for the stock that fell out of grace on the day the FDA placed this clinical hold on their Phase IIb clinical trial for Arimoclomol- a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

Recently, there has been a sudden injection of interest and excitement in the company has not been seen since early 2008, when the U.S. Food and Drug Administration surprised many in the biotech community by placing the company's promising Lou Gehrig's drug Arimoclomol on ice.

Months earlier, the drug had been making headlines and offering tremendous hope to those suffering with the disease. In fact, prior to the surprise announcement, the company had been looking forward to showcasing the substantial potential for arimoclomol for ALS, stroke recovery and other neurodegenerative diseases.

Just yesterday, the company took a very telling step in the direction which has been rumored to be a new focus for the company: a headstrong march into the very hot oncology sector of the market. Cytrx named industry veteran Scott Geyer Senior Vice President of Manufacturing. Geyer brings Cytrx more than 28 years of manufacturing and technical operations knowledge overseeing all aspects of product manufacturing in oncology and other fields, including direct experience with small molecules, biologics and topicals.

BiomedReports has been hearing rumors that the company has been considering acquiring "a company or two" with oncology drugs in Phase II and III of development. Company officials would not comment specifically about those rumors, but industry sources say that CEO Steve Kreigsman and his team have been "kicking tires and looking closely under the hood" of as many as a dozen companies which may either be in need of capital or seeking partnerships. Cytrx announced suprise earnings last quarter and are well equiped to go out and make such a deal given their healthy stash of cash.

"Kreigsman is very sharp when it comes to finding good companies for a great price given his background in finance," said one former broker who knows the company CEO. "It would not surprise me to see the company make such a move at all from him. He knows how to find and pick winners."

In a prepared statement yesterday, Kreigsman said, "We are assembling a team of prominent leaders within their respective fields, bringing CytRx greater expertise and a new, higher energy level that will assist with our aggressive plans to initiate multiple clinical trials next year and achieve our goals of transitioning to a commercial oncology company and building substantial stockholder value... Scott Geyer fills an essential role on our team providing the important manufacturing perspective necessary to conduct clinical trials that will allow us to pursue drug registration or partnering with pharmaceutical or biotechnology companies."

We continue to see a much higher price for this stock in the coming months, especially if the company can continue to meet milestones and position themselves as they are planning to. The lift of this FDA hold is critical because it shows that the company is developing real, innovative science and because credibility is everything in today's volatile market.  Even if they only manage to report positive results of on-going clinical trials for their existing pipeline, share price will be impacted.

Going on record very conservatively, after spending some time speaking to insiders and studying the company closely, we see this as an $8 to $10 stock in twelve to fifteen months as we continue to look for a very positive news flow from Cytrx and some key developments ahead.

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